A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Phase: PHASE3
Conditions: Metastatic Castration-sensitive Prostate Cancer
Sponsor: Janssen Research & Development, LLC

CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
1
Status: Approved, Date: 28 August 2023
Janssen Research & Development *
Clinical Protocol
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in
Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and
Prednisone for the Treatment of Participants with Deleterious Germline or Somatic
Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive
Prostate Cancer (mCSPC)
AMPLITUDE
Protocol 67652000PCR3002; Phase 3
AMENDMENT 4
CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
*Janssen Research & Development is a global organization that operates through different legal entities in
various countries/territories. Therefore, the legal entity acting as the sponsor for Janssen Research &
Development studies may vary, such as, but not limited to Janssen Biotech, Inc.; Janssen Products, LP;
Janssen Biologics, BV; Janssen-Cilag International NV; Janssen, Inc; Janssen Pharmaceutica NV; Janssen
Sciences Ireland UC; Janssen Biopharma Inc.; or Janssen Research & Development, LLC. The term
“sponsor” is used throughout the protocol to represent these various legal entities; the sponsor is
identified on the Contact Information page that accompanies the protocol.
United States (US) sites of this study will be conducted under US Food & Drug Administration
Investigational New Drug (IND) regulations (21 CFR Part 312).
IND: 131190
EudraCT NUMBER: 2020-002209-25
EU Trial Number: 2023-506365-64
Status: 
Approved
Date: 
28 August 2023
Prepared by: Janssen Research & Development, LLC
EDMS number: 
EDMS-ERI-207490517, 8.0
GCP Compliance: This study will be conducted in compliance with Good Clinical Practice, and applicable regulatory
requirements.
Confidentiality Statement
The information provided herein contains Company trade secrets, commercial or financial information that the Company
customarily holds close and treats as confidential. The information is being provided under the assurance that the recipient
will maintain the confidentiality of the information under applicable statutes, regulations, rules, protective orders or
otherwise.
NCT04497844 

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
2
Status: Approved, Date: 28 August 2023
PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE
DOCUMENT HISTORY
Amendment 4 
28 August 2023
Amendment 3 
09 February 2023
Amendment 2 
25 October 2021
Amendment 1 
21 December 2020
Original Protocol 
10 June 2020
Amendment 4 (28August 2023)
Overall Rationale for the Amendment: The overall rationale for this amendment is to modify the
secondary  efficacy endpoint from “Symptomatic progression free survival” to “Time to symptomatic
progression”. In addition, this amendment consolidates the protocol for European Clinical Trial Regulation
(EU CTR) transition.
The changes made to the clinical protocol 67652000PCR3002 as part of Protocol Amendment 4 are listed
below, including the rationale of each change and a list of all applicable sections. Changes made in previous
protocol amendments are listed in Section 10.12 Appendix 12: Protocol Amendment History.
Section number 
and Name
Description of Change 
Brief Rationale
Title page 
Added IND and EU Trial numbers. 
To comply with EU CTR
requirements.
1.1. Synopsis 
Added reference to protocol version and date, 
including IND, Eudra CT, and EU Trial 
numbers.
To comply with EU CTR
requirements.
1.1. Synopsis 
Added a Benefit-risk Assessment subsection. 
To comply with EU CTR
requirements.
1.1. Synopsis 
Deleted text: “All participants will receive 
ADT (ie, gonadotropin-releasing hormone 
analogue or surgical castration).”
Removed as this is not included
as study treatment.
1.3. Schedule of Activities 
(SoA), Table 2 
New Footnote “a” added to title of Table 2: 
“The Open-label Extension Phase and/or 
Long-term Extension Phase will begin upon
notification from the Sponsor. At that time, the
applicable procedures should be followed, as
detailed in Appendix 10: Open-label Extension
Phase and Appendix 11: Long-term Extension
Phase.”
Subsequent footnote order modified.
To clarify details of the OLE
and LTE Phases.
1.3. Schedule of Activities 
(SoA), Table 2 
Modified language for CT or MRI Note: 
“Until radiographic progression. See 
Section 8.1.1 for details.”
To encourage the submission of
imaging in trial follow-up phase.
1.3. Schedule of Activities 
(SoA), Table 2 
Survival status Footnote “c” added: “May be 
obtained at a shorter interval than every 
4 months during follow-up if required for
database lock.”
To clarify that more frequent
follow-up is permitted.
3. Objectives and 
Endpoints; 9.4.3. 
Secondary Endpoints 
Modify the secondary efficacy endpoint from 
“Symptomatic progression free survival” to 
“Time to symptomatic progression”. 
To capture a patient-centered
endpoint. As death for any cause
is captured in radiographic
progression-free survival (rPFS)
and overall survival, it was
removed from the endpoint
related to symptomatic
progression.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
3
Status: Approved, Date: 28 August 2023
Section number 
and Name
Description of Change 
Brief Rationale
No changes were made to the
corresponding objective.
3. Objectives and 
Endpoints; 9.4.4. Other 
Endpoints 
“Overall response” to “Objective response”. 
To align protocol with Response
Evaluation Criteria in Solid
Tumors (RECIST) terminology.
3. Objectives and 
Endpoints; 9.4.3 
Secondary Endpoints 
Footnote “b”: "Death from any cause" removed 
from definition of endpoint. 
Updated to correspond to the
secondary endpoint
modification.
4.4. End of Study 
Definition  
Language added to include the Open-label 
Extension (OLE) and Long-term Extension 
(LTE) Phases as part of End of Study
Definition.
Definition updated to align with
EU regulations.
5.4. Screen Failures 
Text added to specify whether the investigator 
will use interactive web response system 
(IWRS) to directly generate screening and 
enrollment logs.
IWRS language added to align
with sponsor template
requirement.
6.1. Study Medication(s) 
Administered 
Table added providing designations of the 
study medicinal products (investigational 
medicinal product [IMP], non-IMP/Auxiliary
Medicinal Product [AxMP]) to clarify
medicinal product designations and conform
with the definitions under EU CTR.
To comply with EU CTR
regulations.
6.1.2. Study Medication, 
Table 6 
Niraparib dosage formulation updated to 
include “or tablet”.
Added footnote: “*Niraparib tablet may only
be used during the Open-Label
Extension/Long-Term Extension Phase after
regulatory approval in the jurisdiction as
applicable.”
To align with available supply.
6.5. Dose Modification, 
Table 9 
Sub-bullet in Hematological Toxicities notes 
section changed from “or” to “and”.
Minor edit to improve clarity.
6.8. Concomitant Therapy  
The text “study medication” was removed. 
Text removed to include only
relevant items in this section.
8.1.1. Evaluations for 
Primary Efficacy 
Assessment 
Language added: “Sites are encouraged to 
continue submitting scans until radiographic 
progression is confirmed by both the
investigator and blinded independent central
review.”
To encourage the submission of
imaging in trial follow-up phase.
8.3.4. Regulatory 
Reporting Requirements 
for Serious Adverse Events
and Anticipated Events
First sentence modified to include mandatory 
safety reporting text. 
To align with sponsor template
requirement.
8.6. Biomarkers 
Language added: “Sample collection and 
testing will comply with local regulations.” 
To align with sponsor template
requirement.
9.4.6 Other Analyses 
Text deleted: “For each treatment group,” 
Text deleted to improve clarity.
10.1. Appendix 1: 
Abbreviations 
The list of abbreviations was updated. 
The list is updated to include
new terms and abbreviations
used in revised text.
10.2. Appendix 2: 
Regulatory, Ethical, and 
Study Oversight 
Considerations
Under Subheading “Informed Consent 
Process”, modification was made to the 
preference to allow virtual reconsent.
To clarify where virtual
reconsent is allowed.
10.2. Appendix 2: 
Regulatory, Ethical, and 
New subsection added, “Recruitment Strategy”. To comply with EU CTR
regulations and sponsor template
requirements.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
4
Status: Approved, Date: 28 August 2023
Section number 
and Name
Description of Change 
Brief Rationale
Study Oversight
Considerations
10.2. Appendix 2: 
Regulatory, Ethical, and 
Study Oversight 
Considerations 
Updated the section on data protection to 
comply with EU CTR requirements and 
sponsor template. 
To clarify rules on protection of
personal data to comply with EU
CTR regulations and sponsor
template.
10.5. Appendix 5: 
Guidance on Study 
Conduct During the
COVID-19 Pandemic
Full references updated to align with reference 
standard in the protocol. 
To align with the sponsor
template requirement.
10.10. Appendix 10: 
Open-label Extension 
Phase 
Text rewritten to clarify the details of the OLE 
Phase. 
Text updated to clarify
procedures during the OLE
Phase.
10.11. Appendix 11: 
Long-term Extension 
Phase
Language added to clarify the end of 
participation in the LTE Phase. 
To clarify details of the LTE
Phase.
10.12. Appendix 12: 
Protocol Amendment 
History
The Protocol Amendment 3 Summary of 
Changes table was moved to Appendix 12. 
To align with the sponsor
template requirement.
Throughout the protocol 
Minor grammatical, formatting, or spelling 
changes were made.
Minor errors were noted.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
5
Status: Approved, Date: 28 August 2023
TABLE OF CONTENTS
PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE ............................................................... 2
TABLE OF CONTENTS ............................................................................................................................... 5
LIST OF IN-TEXT TABLES AND FIGURES................................................................................................ 8
1. 
PROTOCOL SUMMARY..................................................................................................................... 9
1.1. 
Synopsis........................................................................................................................................... 9
1.2. 
Schema.......................................................................................................................................... 12
1.3. 
Schedule of Activities (SoA)........................................................................................................... 13
2. 
INTRODUCTION................................................................................................................................ 20
2.1. 
Study Rationale.............................................................................................................................. 21
2.1.1. 
Background on mCSPC.............................................................................................................. 21
2.1.2. 
Role of Deleterious Germline or Somatic HRR Gene Alterations in Prostate Cancer ............... 21
2.2. 
Background.................................................................................................................................... 22
2.2.1. 
Summary of Available Nonclinical and Clinical Data for Niraparib............................................. 22
2.2.2. 
Summary of Available Nonclinical and Clinical Data for AA Plus Prednisone ........................... 23
2.2.3. 
Summary of Available Clinical Data for Niraparib and AA Plus Prednisone in Prostate
Cancer........................................................................................................................................ 24
2.3. 
Benefit-Risk Assessment............................................................................................................... 26
3. 
OBJECTIVES AND ENDPOINTS ..................................................................................................... 27
4. 
STUDY DESIGN ................................................................................................................................ 29
4.1. 
Overall Design................................................................................................................................ 29
4.2. 
Scientific Rationale for Study Design............................................................................................. 30
4.2.1. 
Participant Input into Design....................................................................................................... 31
4.2.2. 
Study-Specific Ethical Design Considerations ........................................................................... 32
4.3. 
Justification for Dose...................................................................................................................... 32
4.4. 
End of Study Definition................................................................................................................... 33
5. 
STUDY POPULATION ...................................................................................................................... 33
5.1. 
Inclusion Criteria............................................................................................................................ 35
5.2. 
Exclusion Criteria........................................................................................................................... 37
5.3. 
Lifestyle Considerations................................................................................................................. 39
5.4. 
Screen Failures.............................................................................................................................. 40
6. 
STUDY MEDICATION AND CONCOMITANT THERAPY................................................................ 41
6.1. 
Study Medication(s) Administered ................................................................................................. 41
6.1.1. 
ADT Administration..................................................................................................................... 41
6.1.2. 
Study Medication ........................................................................................................................ 41
6.1.3. 
Special Dosing Instructions for Pharmacokinetic Visits.............................................................. 45
6.2. 
Preparation/Handling/Storage/Accountability ................................................................................ 45
6.3. 
Measures to Minimize Bias: Randomization and Blinding............................................................. 46
6.4. 
Study Medication Compliance ....................................................................................................... 47
6.5. 
Dose Modification........................................................................................................................... 48
6.5.1. 
Posterior Reversible Encephalopathy Syndrome (PRES).......................................................... 52
6.6. 
Continued Access to Study Medication After the End of the Study............................................... 52
6.7. 
Treatment of Overdose .................................................................................................................. 53
6.8. 
Concomitant Therapy..................................................................................................................... 53
6.8.1. 
Permitted Supportive Care and Interventions............................................................................. 53
6.8.2. 
Prohibited Concomitant Therapies ............................................................................................. 54
6.8.3. 
Restricted Concomitant Medications.......................................................................................... 54
7. 
DISCONTINUATION OF STUDY MEDICATION AND PARTICIPANT
DISCONTINUATION/WITHDRAWAL............................................................................................... 55

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
6
Status: Approved, Date: 28 August 2023
7.1. 
Discontinuation of Study Medication.............................................................................................. 55
7.2. 
Participant Discontinuation/Withdrawal From the Study................................................................ 55
7.2.1. 
Withdrawal From the Use of Research Samples ....................................................................... 57
7.3. 
Lost to Follow-up............................................................................................................................ 57
8. 
STUDY ASSESSMENTS AND PROCEDURES ............................................................................... 58
8.1. 
Efficacy Assessments .................................................................................................................... 61
8.1.1. 
Evaluations for Primary Efficacy Assessment............................................................................ 61
8.1.1.1. 
Criteria for Primary Endpoint................................................................................................... 61
8.1.2. 
Evaluations for Other Efficacy Assessments.............................................................................. 62
8.1.2.1. 
Patient Reported Outcomes .................................................................................................... 62
8.1.2.1.1. 
BPI-SF.................................................................................................................................. 63
8.1.2.1.2. 
FACT-P ................................................................................................................................ 63
8.1.2.1.3. 
EQ-5D-5L............................................................................................................................. 63
8.1.2.1.4. 
PRO CTCAE ........................................................................................................................ 64
8.1.2.2. 
ECOG Performance Status ..................................................................................................... 64
8.2. 
Safety Assessments....................................................................................................................... 64
8.2.1. 
Physical Examinations................................................................................................................ 64
8.2.2. 
Vital Signs................................................................................................................................... 64
8.2.3. 
ECGs .......................................................................................................................................... 65
8.2.4. 
Clinical Safety Laboratory Assessments .................................................................................... 65
8.3. 
Adverse Events and Serious Adverse Events ............................................................................... 66
8.3.1. 
Time Period and Frequency for Collecting Adverse Event and Serious Adverse Event
Information.................................................................................................................................. 66
8.3.2. 
Method of Detecting Adverse Events and Serious Adverse Events .......................................... 67
8.3.3. 
Follow-up of Adverse Events and Serious Adverse Events ....................................................... 67
8.3.4. 
Regulatory Reporting Requirements for Serious Adverse Events and Anticipated
Events......................................................................................................................................... 67
8.3.5. 
Pregnancy................................................................................................................................... 68
8.3.6. 
Disease-Related Events and Disease-Related Outcomes Not Qualifying as Adverse
Events or Serious Adverse Events............................................................................................. 68
8.3.7. 
Adverse Events of Special Interest............................................................................................. 69
8.4. 
Pharmacokinetics........................................................................................................................... 69
8.4.1. 
Evaluations ................................................................................................................................. 69
8.4.2. 
Analytical Procedures................................................................................................................. 69
8.4.3. 
Pharmacokinetic Parameters and Evaluations........................................................................... 70
8.5. 
Genetics ......................................................................................................................................... 70
8.6. 
Biomarkers..................................................................................................................................... 70
8.6.1. 
Evaluations ................................................................................................................................. 71
8.6.1.1. 
Plasma for RNA....................................................................................................................... 71
8.6.1.2. 
Plasma for DNA....................................................................................................................... 71
8.6.1.3. 
Tumor Tissue Analysis ............................................................................................................ 71
8.7. 
Medical Resource Utilization and Health Economics .................................................................... 71
8.8. 
Qualitative Exit Interview................................................................................................................ 72
9. 
STATISTICAL CONSIDERATIONS.................................................................................................. 72
9.1. 
Statistical Hypotheses.................................................................................................................... 72
9.2. 
Sample Size Determination ........................................................................................................... 73
9.3. 
Populations for Analyses................................................................................................................ 73
9.4. 
Statistical Analyses ........................................................................................................................ 73
9.4.1. 
General Considerations.............................................................................................................. 74
9.4.1.1. 
Multiplicity Adjustment for Testing of Primary and Key Secondary Endpoints........................ 74
9.4.2. 
Primary Endpoint ........................................................................................................................ 74
9.4.3. 
Secondary Endpoints.................................................................................................................. 74
9.4.4. 
Other Endpoints.......................................................................................................................... 74
9.4.4.1. 
Patient-reported Outcomes Analyses...................................................................................... 75
9.4.5. 
Safety Analyses.......................................................................................................................... 75
9.4.6. 
Other Analyses ........................................................................................................................... 76

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
7
Status: Approved, Date: 28 August 2023
9.5. 
Interim Analysis for Overall Survival .............................................................................................. 78
9.6. 
Data Monitoring Committee or Other Review Board ..................................................................... 78
10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ............................ 79
10.1. 
Appendix 1: Abbreviations ............................................................................................................. 79
10.2. 
Appendix 2: Regulatory, Ethical, and Study Oversight Considerations......................................... 81
REGULATORY AND ETHICAL CONSIDERATIONS .......................................................................... 81
FINANCIAL DISCLOSURE .................................................................................................................. 84
INFORMED CONSENT PROCESS ..................................................................................................... 84
RECRUITMENT STRATEGY............................................................................................................... 85
DATA PROTECTION ........................................................................................................................... 85
LONG-TERM RETENTION OF SAMPLES FOR FUTURE RESEARCH............................................. 86
COMMITTEES STRUCTURE .............................................................................................................. 86
PUBLICATION POLICY/DISSEMINATION OF CLINICAL STUDY DATA........................................... 87
DATA QUALITY ASSURANCE ............................................................................................................ 88
CASE REPORT FORM COMPLETION ............................................................................................... 88
SOURCE DOCUMENTS ...................................................................................................................... 89
MONITORING ...................................................................................................................................... 90
ON-SITE AUDITS................................................................................................................................. 90
RECORD RETENTION ........................................................................................................................ 90
STUDY AND SITE START AND CLOSURE........................................................................................ 91
10.3. 
Appendix 3: Additional Information on CYP450 Drug Interactions ................................................ 92
10.4. 
Appendix 4: Adverse Events, Serious Adverse Events, Product Quality Complaints, and
Other Safety Reporting: Definitions and Procedures for Recording, Evaluating, Follow-up,
and Reporting................................................................................................................................. 93
ADVERSE EVENT DEFINITIONS AND CLASSIFICATIONS.............................................................. 93
ATTRIBUTION DEFINITIONS.............................................................................................................. 94
SEVERITY CRITERIA.......................................................................................................................... 94
SPECIAL REPORTING SITUATIONS ................................................................................................. 94
PROCEDURES .................................................................................................................................... 95
CONTACTING SPONSOR REGARDING SAFETY............................................................................. 96
PRODUCT QUALITY COMPLAINT HANDLING.................................................................................. 96
10.5. 
Appendix 5: Guidance on Study Conduct During the COVID-19 Pandemic ................................. 98
GUIDANCE SPECIFIC TO THIS PROTOCOL .................................................................................... 98
10.6. 
Appendix 6: ECOG Performance Status...................................................................................... 101
10.7. 
Appendix 7: Clinical Laboratory Tests ......................................................................................... 102
10.8. 
Appendix 8: Anticipated Adverse Events..................................................................................... 103
10.9. 
Appendix 9: Child-Pugh Criteria................................................................................................... 105
10.10. Appendix 10: Open-label Extension Phase ................................................................................. 106
10.11. Appendix 11: Long-term Extension Phase................................................................................... 110
10.12. Appendix 12: Protocol Amendment History................................................................................. 112
11. REFERENCES................................................................................................................................. 124
INVESTIGATOR AGREEMENT............................................................................................................... 127

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
8
Status: Approved, Date: 28 August 2023
LIST OF IN-TEXT TABLES AND FIGURES
TABLES
Table 1: 
Schedule of Activities for Prescreening Phasea........................................................................ 13
Table 2: 
Schedule of Activities for Screening, Treatment, and Follow-up Phasesa ............................... 14
Table 3: 
Schedule of Pharmacokinetic Assessments............................................................................. 19
Table 4: 
Eligible HRR Gene Alterations.................................................................................................. 31
Table 5: 
Description of Study Medications ............................................................................................. 43
Table 6: 
Single-Agent Formulations ....................................................................................................... 44
Table 7: 
Low-strength niraparib FDC Formulations for Use When Dose Modification is
Required and When Available .................................................................................................. 44
Table 8: 
Guidelines for Dose Modification.............................................................................................. 48
Table 9: 
Guidelines for Dose Modification on Specific Adverse events ................................................. 49
Table 10: Minimum Clinically Important Differences................................................................................. 75
FIGURES
Figure 1: Schematic Overview of the Study............................................................................................. 12
Figure 2. Determination of Molecular Eligibility........................................................................................ 34

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
9
Status: Approved, Date: 28 August 2023
1. 
PROTOCOL SUMMARY
1.1. 
Synopsis
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with
Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of
Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR)
Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Synopsis based on Protocol 67652000PCR3002 Amendment 4, finalized on 23August 2023.
IND: 131190
EudraCT number: 2020-002209-25
EU Trial Number: 2023-506365-64
Niraparib is an orally available, highly selective poly (adenosine diphosphate-ribose) polymerase (PARP)
inhibitor, with potent activity against PARP-1 and PARP-2 deoxyribonucleic acid-repair polymerases.
Abiraterone acetate (AA), the prodrug of abiraterone, inhibits cytochrome P450c17, a critical enzyme in
androgen biosynthesis.
Note: The term mCSPC used throughout this document is synonymous with metastatic hormone-sensitive
prostate cancer (mHSPC).
BENEFIT-RISK ASSESSMENT
The combination of niraparib and AA, plus prednisone is hypothesized to have a positive benefit-risk profile
when used for the treatment of patients with mCSPC, as proposed for this study.
Taking into account the measures incorporated to minimize risk to participants of this study, the potential
risks identified in association with niraparib/AA fixed-dose combination (FDC), niraparib and AA, plus
prednisone are justified by the anticipated benefits that may be afforded to participants with mCSPC.
OBJECTIVES AND ENDPOINTS
 
To determine if niraparib and AA, plus prednisone compared with AA plus prednisone in participants
with deleterious germline or somatic HRR gene-mutated mCSPC provides superior efficacy in
improving radiographic progression-free survival (rPFS).
 
To assess the clinical benefit of niraparib and AA, plus prednisone compared with AA plus prednisone
in participants with deleterious germline or somatic HRR gene-mutated mCSPC.
 
To characterize the safety profile of niraparib and AA, plus prednisone compared with AA plus
prednisone in participants with deleterious germline or somatic HRR gene-mutated mCSPC.
HYPOTHESIS
The primary hypothesis of this study is that niraparib and AA, plus prednisone will improve rPFS
compared with AA plus prednisone in participants with deleterious germline or somatic HRR gene-
mutated mCSPC.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
10
Status: Approved, Date: 28 August 2023
OVERALL DESIGN
This is a randomized, placebo-controlled, double-blind, multinational Phase 3 treatment study to evaluate
the safety and efficacy of niraparib and AA, plus prednisone compared with AA plus prednisone in men
over the age of 18 years with deleterious germline or somatic HRR gene-mutated mCSPC.
Approximately 692 participants will be randomly assigned in a 1:1 ratio to either niraparib 200 mg, and
AA 1000 mg, plus prednisone 5 mg daily or AA 1000 mg plus prednisone 5 mg daily. All participants must
be receiving background androgen deprivation therapy (ADT; ie, gonadotropin-releasing hormone
analogue (GnRHa) or surgical castration).
The study will consist of 4 phases: a Prescreening Phase for biomarker evaluation for eligibility only, a
Screening Phase, a Treatment Phase, and a Follow-up Phase.
Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed according to the Schedule of
Activities (SoA).
Treatment is continuous; however, a treatment cycle is defined as 28 days. Study medication should
continue until disease progression, unacceptable toxicity, death, withdrawal of consent, or termination of
the study by the sponsor. Patients with radiographic progression can remain on therapy if still receiving
clinical benefit.
Participants will be followed until death or termination of the study. In addition to survival follow-up, data
will continue to be collected to evaluate all of the secondary and other endpoints. The Euro-Quality of Life
Questionnaire will also be administered for up to 1 year after study medication discontinuation.
Participants will be monitored for safety during the Prescreening, Screening, and Treatment Phases and up
to 30 days after the last dose of study medication during the follow-up phase. Adverse events (AEs)
including clinically significant laboratory abnormalities reported as AEs, will be graded and summarized
using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.
An Independent Data Monitoring Committee will be commissioned for this study and will perform regular
review of study data.
NUMBER OF PARTICIPANTS
Approximately 692 participants will be randomly assigned in this study.
TREATMENT GROUPS AND DURATION
Participants will be randomized in a 1:1 ratio to 1 of 2 treatments groups:
 
niraparib 200 mg and AA 1000 mg, plus prednisone 5 mg daily (Experimental)
 
AA 1000 mg plus prednisone 5 mg daily (Control).
All study medications will be administered orally once daily. Matching placebos will also be administered.
EFFICACY EVALUATIONS
The primary endpoint for this study is rPFS as assessed by the investigator which will be evaluated using
computed tomography or magnetic resonance imaging scans and whole-body bone scans
(Technetium-99m). Evaluation of rPFS will also be assessed by blinded independent central review.
Additional efficacy assessments are described in the SoA.
PHARMACOKINETIC EVALUATIONS
Venous blood samples collected to measure plasma concentrations are described in the SoA.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
11
Status: Approved, Date: 28 August 2023
BIOMARKER EVALUATIONS
Deleterious germline or somatic HRR gene alterations will be evaluated using the sponsor’s approved
assays to determine molecular eligibility at prescreening from (a) tumor tissue (archival or recently
collected), and (b) germline (eg, blood, saliva), and also (c) plasma (if test is available from the sponsor).
The type of samples, testing methodology, and gene alterations to determine eligibility may be updated by
the sponsor and any changes will be communicated to investigators by letter. In lieu of prescreening, prior
local HRR testing performed in a Clinical Laboratory Improvement Amendment-certified (CLIA) or
equivalent laboratory may be used. Sponsor must approve participant’s HRR alteration status prior to
randomization based on receipt of a redacted biomarker report(s).
All participants will have additional exploratory research samples collected where local regulations allow.
PHARMACOGENOMIC (DNA) EVALUATIONS
A blood or saliva sample will be collected to allow for pharmacogenomic evaluation of deleterious germline
HRR gene alterations (where local regulations permit). Additional research may be done on collected
samples to identify predictors of response to niraparib and AA or to allow for bridging and/or diagnostic
test development where local regulations allow.
SAFETY EVALUATIONS
Safety assessments will be based on review of AE reports and the results of heart rate and blood pressure
measurements, electrocardiograms (ECGs), physical examinations, and clinical safety laboratory tests at
specified timepoints described in the SoA.
STATISTICAL METHODS
Efficacy
Approximately 692 participants will be randomized in a 1:1 ratio to receive niraparib and AA, plus
prednisone or AA plus prednisone. The primary endpoint of rPFS and other event-driven secondary
endpoints will be analyzed when sufficient events have been observed.
Safety
Safety parameters to be analyzed are the incidence, intensity, and type of AEs and clinically significant
changes in the participant’s physical examination, ECGs, heart rate, blood pressure, and clinical laboratory
results.
Pharmacokinetics
If feasible, population PK analysis of plasma concentration-time data and exposure-response analysis for
selected efficacy and safety endpoints may be performed.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
13
Status: Approved, Date: 28 August 2023
1.3. 
Schedule of Activities (SoA)
Table 1: 
Schedule of Activities for Prescreening Phasea
Study Procedure 
Notes
Prescreening Informed Consent 
Must be obtained (written or remote/virtual) before first study-related procedure
Biomarker samples for eligibility –submit (if test is 
available from the sponsor): 
1. Tumor tissue
2. Germline sample (eg. Blood, saliva)
3. Plasma
The type of samples and testing methodology to determine eligibility may be updated by the sponsor and
any changes will be communicated to investigators by letter.
Prescreening related serious adverse events 
Only serious adverse events related to study procedures should be reported from the time the
prescreening informed consent is obtained.
a. For participants who do not have prior results available from local testing, performed at a Clinical Laboratory Improvement Amendment-certified (CLIA) or
equivalent laboratory.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
18
Status: Approved, Date: 28 August 2023
EoT = End-of-Treatment; EQ-5D-5L=Euro Quality of Life Questionnaire; FACT-P=Functional Assessment of Cancer Therapy –Prostate Questionnaire; INR=
International normalized ratio; PRO-CTCAE= Patient-reported Outcomes Common Terminology Criteria for Adverse Events; PT=prothrombin time; LFT=liver
function tests; m=month; MRI=magnetic resonance imaging; PSA=prostate-specific antigen; q=every; RNA=ribonucleic acid; 99mTc=technetium-99m
a. The Open-label Extension Phase and/or Long-term Extension Phase will begin upon notification from the Sponsor. At that time, the applicable procedures
should be followed, as detailed in Appendix 10: Open-label Extension Phase and Appendix 11: Long-term Extension Phase.
b. Re-consenting may be done remotely/virtually as per local regulations and in accordance with the sponsor policy.
c. May be obtained at a shorter interval than every 4 months during follow-up if required for database lock.
d. Where local regulations permit.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
19
Status: Approved, Date: 28 August 2023
Table 3: 
Schedule of Pharmacokinetic Assessments
Phase 
Treatment
Cycle 
Cycle 2a 
Cycle 3a 
Cycles 4 to 7b
Day  
1 
1 
1
Visit Window  
+3 Days
Time 
Predose 
0 
+1-3 h 
Predose 
0 
+1-3 h 
Predose 
0 
>+3 h
Administration of study medication  
X 
X 
X
PK blood sample 
X 
X 
X 
X 
X 
or 
X
PK=pharmacokinetic
a. 
On Day 1 of Cycles 2 and 3, study medications should be taken at the site under the supervision of the investigator or designee and should not be taken at home on
the morning ofthe visits. If the participant takes the study medications prior to the visit, the PK samples should be obtained at the next cycle.
b. 
On Day 1 of Cycles 4 through 7, 1 PK sample is to be obtained either predose or at least 3 hours postdose. If the study visit is in the morning, participants should
refrain from taking the study medications until after the PK sample is obtained at the investigative site. If the visit is in the afternoon, the participant should take
their study medications in the morning as usual and the PK sample will be collected during the study visit.
Note: The date and time of the PK samples and of the study medications administered at the investigative site and prior doses taken at home should be recorded.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
20
Status: Approved, Date: 28 August 2023
2. 
INTRODUCTION
Niraparib is an orally available, highly selective poly (adenosine diphosphate [ADP]-ribose)
polymerase (PARP) inhibitor (PARPi), with potent activity against PARP-1 and PARP-2
deoxyribonucleic acid (DNA)-repair polymerases.29 Niraparib is currently being studied in breast
cancer, ovarian cancer, and non-small cell lung cancer. Niraparib was approved in the United
States (US) by the Food and Drug Administration on 27 March 2017 for the maintenance treatment
of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who
are in a complete or partial response to platinum-based chemotherapy. Niraparib also received
European Commission approval (16 November 2017) for use as a monotherapy for the
maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous
epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or
partial) to platinum-based chemotherapy (EMA/CHMP/574018/2017).
Abiraterone acetate [AA; JNJ-212082]) is a pro-drug of abiraterone (JNJ-589485) 17-(3-pyridyl)
androsta-5,16-dien-3β-ol], which is an androgen biosynthesis inhibitor. Abiraterone selectively
inhibits the enzyme cytochrome P450 (CYP)c17, which is found in the testes and adrenals, as well
as in prostate tissues and tumors.40 The clinical benefits of AA plus prednisone or prednisolone
(AAP) for the treatment of prostate cancer were demonstrated in 3 large, randomized, double-
blind, placebo-controlled Phase 3 studies. These studies included patients with metastatic
castration-resistant prostate cancer (mCRPC) post-chemotherapy (COU-AA-301), chemotherapy-
naïve patients (COU-AA-302), and patients with high-risk metastatic hormone-naïve disease
(LATITUDE).11,20,42,45 Abiraterone acetate plus prednisone is currently approved in more than
100 countries worldwide for the treatment of men with metastatic prostate cancer (exact wording
of indications varies by region).34
This study evaluates the efficacy of niraparib and AA, plus prednisone compared with AA plus
prednisone in men with deleterious germline or somatic homologous recombination repair (HRR)
gene-mutated metastatic castration-sensitive prostate cancer (mCSPC) receiving androgen
deprivation therapy (ADT).
For the most comprehensive nonclinical and clinical information regarding niraparib and AA refer
to the latest version of the Investigator's Brochure (IB) and Addenda for niraparib25 and AA.26
Information regarding the niraparib/AA fixed-dose combination (FDC) is in the niraparib/AA FDC
IB.24
The term “study medication” throughout the protocol, refers to study drugs (ie, FDC, niraparib,
AA, or relevant placebo, and prednisone).
The term "sponsor" used throughout this document refers to the entities listed in the Contact
Information page(s), which will be provided as a separate document.
The term "participant" throughout the protocol refers to the common term "subject".

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
21
Status: Approved, Date: 28 August 2023
The term mCSPC used throughout this document is synonymous with metastatic
hormone-sensitive prostate cancer (mHSPC).
2.1. 
Study Rationale
2.1.1. Background on mCSPC
Prostate cancer is the second most common cancer in men worldwide, with an estimated annual
global incidence in 2018 of 1.3 million and mortality of 358,989.4 In the United States, in 2019,
the incidence was estimated at 174,650 new cases with 31,620 deaths.51 In 2015 in the European
Union (EU), the incidence of new cases was estimated at 365,000 with 77,000 deaths.9 For patients
who develop metastatic disease, the 5-year relative survival is only 30%.54 Prognostic factors that
influence survival in mCSPC include high prostate-specific antigen (PSA) at diagnosis, high
Gleason score, higher primary tumor stage, worse World Health Organization (WHO)
performance status, younger age, and the presence of bone metastases. Bone metastases are the
most common site of metastases in patients with prostate cancer and are a major cause of morbidity
and mortality, and therefore pose a substantial burden as they are associated with skeletal-related
events, pain, and the need for radiation therapy or surgery to bone.52
2.1.2. Role of Deleterious Germline or Somatic HRR Gene Alterations in Prostate
Cancer
Poly (adenosine diphosphate-ribose) polymerases are a family of nuclear protein enzymes
involved with the DNA damage response.15 PARP-1 and PARP-2 are zinc-finger DNA-binding
polymerases that detect damaged DNA and promote DNA repair by several mechanisms. After
detecting DNA damage, PARP activates the base excision repair pathway via an intracellular
signaling mechanism. In cells incapable of DNA repair via homologous repair due to deleterious
alterations, PARP inhibition leads to irreparable DNA double-strand breaks, collapsed replication
forks, and an increased use of the non-homologous end joining pathway. These disruptions result
in genomic instability and ultimately cell death. Treatment with a PARPi represents an opportunity
to selectively kill cancer cells with deficiencies in homologous recombination and other DNA
repair mechanisms.18
Prostate cancer is a heterogenous disease, and not all patients have the same response to therapy.
Recent genomic analyses have highlighted specific germline and somatic alterations and
alternative driver growth signaling pathways in patients with metastatic disease.2,44,57 Deleterious
germline or somatic homologous HRR gene alterations, with breast cancer gene (BRCA) being
the most common, in particular are associated with aggressive disease, rapid progression rates,
treatment resistance, and poor prognosis with death at an early age.1,2,36 Up to 20% to 30% of
advanced prostate cancers may harbor these deleterious germline or somatic HRR gene
alterations.14,32
Based on recent clinical information, National Comprehensive Cancer Network (NCCN)
guidelines (v4  Feb 2019)37 recommend testing for alterations in HRR genes in tumors from
patients with mCRPC and also screening for germline alterations in breast cancer 2 (BRCA2) and
other DNA repair damage genes in all patients with high-risk localized prostate cancer and

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
22
Status: Approved, Date: 28 August 2023
metastatic disease. However, currently there is no approved targeted therapy tailored for patients
with mCSPC and deleterious germline or somatic HRR gene-mutated mCSPC. Current treatment
management sequences result in shorter responses and shorter survival in patients carrying
deleterious germline or somatic HRR gene alterations such as BRCA2.39 The Spanish
PROREPAIR-B Study demonstrated that patients with mCSPC who were carrying breast cancer 1
(BRCA1), (BRCA2), ataxia telangiectasia mutated (ATM), or partner and localizer of BRCA2
(PALB2) germline alterations had shorter median time to reach castration resistance from the start
of ADT: 18.6 months (range: 10.6 to 26.6 months) in carriers versus 28.4 months (range: 24.2 to
32.6 months) in non-carriers. Progression to mCRPC in the ATM/BRCA1/BRCA2/PALB2 group
was frequently accompanied by radiographic progression (61.5%; p=0.015 versus noncarriers),
particularly in BRCA2 carriers (71.4%; p=0.011 versus noncarriers). When DNA-repair gene
defect (DRD) positive patients developed mCRPC, the response to first next generation androgen-
receptor (AR)-targeting agent was poor, and cause specific survival was halved in germline
BRCA2 carriers (17.4 versus 33.2 months; p=0.027), and germline BRCA2 alterations were
identified as an independent prognostic factor for cause-specific survival (hazard ratio [HR]=2.11;
p=0.033).5 Thus, deleterious germline or somatic HRR gene alterations, particularly BRCA2, are
prognostic for a high risk of tumor progression and predictive of the development of resistance to
androgen targeted therapies. Cyclin dependent kinase 12 (CDK12) is thought to have a distinct
role in maintaining genomic stability. In prostate cancer, inactivating CDK12 alterations are found
in 6-7% of cases.3
In mCRPC patients with DNA-repair anomalies, previously treated with 1 line of taxane-based
chemotherapy and >1 line of AR-targeted therapy, niraparib monotherapy at a dose of 300 mg has
demonstrated activity (sponsor study 64091742PCR2001). The effectiveness of PARPi in patients
with deleterious germline or somatic HRR gene-mutated prostate cancer was further justified in
the PROfound study, a Phase 3 study in second line mCRPC patients comparing olaparib to
physician’s choice of either enzalutamide or AAP.11 The primary endpoint was radiographic
progression-free survival (rPFS) by blinded independent central review in patients with alterations
in BRCA1, BRCA2, and ATM. Patients that were in the olaparib arm had a median rPFS of
7.4 months versus patients in the physician’s choice arm who had a median rPFS of 3.6 months
(HR 0.34 [0.25, 0.47] p<0.0001). In a sub-analysis, patients harboring BRCA2 had a median rPFS
of 10.84 months when treated with olaparib, while patients treated with either enzalutamide or
AAP had a median rPFS of 3.48 months. The PROfound sub-analysis also showed patients
harboring CDK12 gene alterations treated with olaparib had a median rPFS of 5.09 months while
those treated with either AAP or enzalutamide had an rPFS of 2.20 months. Based on this data,
patients with CDK12 gene alterations are being included in this protocol.
2.2. 
Background
2.2.1. Summary of Available Nonclinical and Clinical Data for Niraparib
A brief summary of the nonclinical and clinical information available for niraparib to date is
provided below. For the most comprehensive nonclinical and clinical information regarding
niraparib, refer to the latest version of the niraparib IB.25

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
23
Status: Approved, Date: 28 August 2023
In an in vitro model, niraparib inhibited PARP-1 and PARP-2 activity with a half-maximal
inhibitory concentration (IC50) of 3.8 and 2.1 nM, respectively. In cultured cells, niraparib
inhibited PARP-dependent PARylation stimulated by DNA damage with an IC50 of 4 nM and a
90% IC90 of 40 nM. When a PARPi such as niraparib is used to treat tumor cells or xenograft
tumors with HRR pathway bearing alterations for BRCA1 and BRCA2, the tumor cell is unable
to efficiently and accurately repair DNA double-strand breaks, which creates a synthetic lethal
condition leading to tumor cell death and ultimately tumor growth inhibition/improved survival.30
Niraparib is currently approved for the treatment of epithelial ovarian, fallopian tube, or primary
peritoneal cancer in multiple lines of therapy58 and is currently being studied in prostate cancer,
breast cancer, ovarian cancer, and non-small cell lung cancer.
In the Phase 3 registration NOVA study (NCT01847274) for patients with ovarian cancer
previously treated with platinum-based chemotherapy, the most common grade 3/4 adverse
events (AE) were thrombocytopenia (29%), anemia (25%), and neutropenia (20%),58 which
represent the identified important risk of hematological toxicity. The other identified risk is
hypertension. Important potential risks include myelodysplastic syndrome/acute myeloid
leukemia (MDS/AML), second primary malignancy, embryo fetal toxicity, pneumonitis and
thrombo-embolic events.
Niraparib is being evaluated as monotherapy in sponsor Study 64091742PCR2001 for the
treatment of patients with mCRPC and DNA-repair anomalies previously treated with at least 1
taxane-based therapy and at least 1 line of AR-directed therapy. As of 23 May 2019, an objective
response rate of 41% was observed in 46 BRCA patients with measurable disease at baseline.53
Preliminary data from this study in 165 patients show that niraparib 300 mg as monotherapy for
the treatment of patients with mCRPC and DRD has a safety profile that is similar to the known
safety profile of the drug for the treatment of platinum-sensitive ovarian cancer. Hematologic
toxicities are a known side effect of niraparib and were also observed in this study (grade 3/4
hematologic toxicities: anemia 29%, thrombocytopenia 15%, and neutropenia 7%); however, the
hematologic toxicities are manageable with standard outpatient care and dose
interruption/reduction. The most common grade 3 or 4 nonhematologic adverse events were
fatigue and back pain (6% each).
2.2.2. Summary of Available Nonclinical and Clinical Data for AA Plus
Prednisone
A brief summary of the clinical information available for AAP is provided below. For the most
comprehensive nonclinical and clinical information regarding AAP, refer to the latest version of
the AA IB.26
Abiraterone acetate, the prodrug of abiraterone, inhibits CYP17A1, a critical enzyme in androgen
biosynthesis. Abiraterone acetate in combination with prednisone is approved for the treatment of
patients with mCRPC and metastatic high-risk castration-sensitive prostate cancer (mCSPC).
The approval in mCSPC is based on a large, randomized, double blind, placebo-controlled Phase 3
study (LATITUDE).21,21 In the LATITUDE study, 1,199 men with newly diagnosed mCSPC were

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
24
Status: Approved, Date: 28 August 2023
randomly assigned to ADT plus AA 1000 mg plus prednisone 5 mg once daily or to ADT plus
placebo. Patients had high-risk disease (cM1) with the presence of at least 2 of 3 high-risk
parameters: Gleason score ≥8, at least 3 bone lesions, and the presence of measurable visceral
metastasis. The pre-specified interim analysis after 406 deaths (169 deaths with AAP and 237 with
placebo and median follow-up of 30.4 months) showed a statistically significant lower risk of
death in the AAP group compared with placebo group (HR 0.62, 95% CI: 0.51, 0.76, p<0.001).20
Median rPFS was also statistically significantly superior with 33 months in the AAP group and
14.8 months in the placebo group (HR 0.47, 95% CI: 0.39, 0.55, p<0.001). Subsequent therapies
that may prolong overall survival (OS) in mCSPC were used by 21% of patients on AAP and 41%
of patients on placebo. The overall incidence of AEs was 93% in both groups. Grade 3 or 4 AEs
were reported in 63% of patients in the AAP group and 48% in the placebo group. Grade 3 and
Grade 4 hypertension were reported in 20% and 0%, respectively, in the AAP group and 10% and
0.2%, respectively, in the placebo group. Grade 3 and Grade 4 hypokalemia were reported in 10%
and 0.8%, respectively, in the AAP group and 10% and 0.2%, respectively in the placebo group.
In an updated survival analysis after 618 deaths (275 deaths with AAP and 343 with placebo and
median follow-up of 51.8 months), OS was significantly longer in the AAP group (median
53.3 months) compared with the placebo group (median 36.5 months; HR 0.66; 95% CI: 0.56-0.78,
p<0.0001).21 In clinical studies of patients with metastatic prostate cancer, the most common AEs
related to AA include peripheral edema, hypokalemia, urinary tract infection, alanine
aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased, dyspepsia,
hematuria, hypertension, and fractures.20,59 AA should be used with caution in patients with a
history of cardiovascular disease. Caution should be exercised when treating patients whose
underlying medical conditions might be compromised by increases in blood pressure,
hypokalemia, or fluid retention.
Prednisone may be associated with fatigue, increased appetite, insomnia, weakness,
hyperglycemia, ecchymosis, and symptoms related to gastroesophageal reflux. With long-term
glucocorticoid therapy, patients may develop Cushing’s syndrome, characterized by central
obesity, thin skin, easy bruising, bone loss, avascular necrosis of the hip, cataract and proximal
myopathy. Withdrawal of the corticosteroid may result in symptoms that include fever, myalgia,
fatigue, arthralgia, and malaise.
2.2.3. Summary of Available Clinical Data for Niraparib and AA Plus Prednisone
in Prostate Cancer
A summary of the nonclinical and clinical information available for niraparib and AA plus
prednisone to date is provided below. For the most comprehensive nonclinical and clinical
information regarding niraparib and AA, refer to the latest versions of the IBs.26,25,26
PARP1 has been shown to be a potent modulator of both AR function and response to DNA
damage.50 There are preclinical data to suggest that the combination of niraparib and AAP may be
beneficial. In preclinical studies by the sponsor in the human vertebral cancer of the prostate
(VCaP) tumor model, mice bearing VCaP tumors were treated with niraparib either alone, or in
combination with AA. The combination of niraparib plus AA showed better inhibition of tumor

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
25
Status: Approved, Date: 28 August 2023
growth and survival prolongation than the single agents (sponsor data). Therefore, DRD is another
mechanism, in addition to AR, which is active in mCSPC, thus simultaneously addressing both
targets could portend greater long term benefit in a deleterious germline or somatic HRR gene-
mutated population which clearly has a continued unmet medical need.
The sponsor evaluated AA 1000 mg plus prednisone 10 mg in combination with either niraparib
200 mg or 300 mg in a Phase 1b study.46 Pharmacokinetic (PK) data suggest no drug-drug
interaction between niraparib and AAP. The steady-state maximum observed plasma
concentration values at 200 mg or 300 mg niraparib in combination with AAP were both within
the recommended Phase 2 dose target exposure range of 575-2501 ng/mL. The steady-state area
under the concentration time curve (AUC)0-24 values at 200 mg and 300 mg were also with the
recommended Phase 2 dose exposure range of 9159-37324 ng.h/mL. Among 4 patients evaluated
in the niraparib 200 mg cohort there were no AE’s that met the dose-limiting toxicity (DLT)
criteria. Among 8 patients evaluated for DLT in the 300 mg dose, one patient experienced 2 DLT
(Grade 3 fatigue and Grade 4 increase in gamma glutamyltransferase). Two additional patients
among these 8 had Grade 4 neutropenia on cycle 2, day 1. An additional 15 patients were enrolled
in an expansion phase for 200 mg niraparib and AAP, for a total of 19 patients treated with this
dose. The most commonly reported treatment-emergent AEs in this cohort were in the system
organ classes of Gastrointestinal disorders (nausea [63.2%], vomiting [52.6%], diarrhea [21.1%])
and General disorders and administration site conditions (fatigue [36.8%]) (sponsor’s internal
data).
Niraparib 200 mg was selected to be the optimal dose to be combined with AA plus prednisone
based on no DLT, an overall tolerable safety profile, and no drug-drug interactions detected
between AA plus prednisone, and niraparib. A FDC formulation of niraparib and AA is currently
being evaluated in several studies including a Phase 1b-2 study of niraparib combination therapies
for the treatment of mCRPC (Protocol 64091742PCR2002), as well as a Phase 1 bioavailability
and bioequivalence study (Protocol 67652000PCR1001).
The sponsor is also conducting a double-blind, randomized, placebo-controlled Phase 3 study to
evaluate the effectiveness of niraparib in combination with AA plus prednisone compared with
AA 
plus 
prednisone 
and 
placebo 
as 
first-line therapy 
in 
mCRPC 
patients
(Study 64091742PCR3001 [MAGNITUDE]). Cohort 1 of MAGNITUDE enrolled 423 patients
with deleterious HRR alterations (HRR+), with the primary endpoint of rPFS by blinded
independent central review in the BRCA1/2 subgroup as well as All HRR+ patients. In the primary
analysis, niraparib in combination with AAP significantly improved rPFS in both the BRCA1/2
subgroup and the All HRR+ patients, reducing the risk of radiographic progression or death by
47% and 27%, respectively, compared with placebo +AAP. Niraparib in combination with AAP
also delayed time to cytotoxic chemotherapy, time to symptomatic progression and improved the
objective response rate in All HRR+ patients. No new safety signals were seen in comparison to
the niraparib and AAP single agent clinical experiences and the 64091742PCR1001 study. Both
Cohorts 1 and 3 (Cohort 3 enrolled HRR+ patients to open-label treatment with the niraparib/AA
FDC) remain ongoing.28

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
26
Status: Approved, Date: 28 August 2023
2.3. 
Benefit-Risk Assessment
The combination of niraparib and AA, plus prednisone is hypothesized to have a positive
benefit-risk profile when used for the treatment of patients with mCSPC, as proposed for this study.
This hypothesis is based on the following:
 Abiraterone acetate plus prednisone is an established standard of care for the treatment of
patients with mCSPC and is included in widely accepted clinical treatment guidelines.35,37
 The addition of niraparib to the AAP backbone regimen may improve initial disease control
and long-term outcomes compared with AAP alone in a biomarker selected population, as
discussed in Section 2.2.3.
 While niraparib is an investigational agent in the castration-sensitive prostate cancer
population, it has been approved for the treatment of ovarian cancer. The safety profile of
niraparib has been characterized in clinical studies as discussed in Section 2.2.1. Data from
sponsor study 64091742PCR1001 and 64091742PCR3001 suggest that the safety profile
of niraparib 200 mg in combination with AA 1000 mg plus prednisone 10 mg in patients
with mCRPC is similar to that described in the ZEJULA® label.58 Known toxicities for
niraparib include gastrointestinal events, hematological events (ie, thrombocytopenia,
neutropenia, and anemia), hypokalemia, and hypertension. These toxicities are managed
by monitoring the appropriate laboratory values and making the appropriate medical
interventions, such as dose interruptions. This protocol includes a targeted monitoring plan
and treatment guidelines to ensure appropriate management of toxicities, including
hematologic toxicities (see Section 6.5). In addition, participants are required to have
specified hematology laboratory values in the inclusion criteria (see Section 5.1) and
uncontrolled hypertension is included as an exclusion criterion (see Section 5.2). As noted
in the Schedule of Activities (SoA), blood pressure, heart rate, and hematology laboratory
values will be monitored through End of Treatment (EoT).
 The toxicities for AAP are well established and include liver function abnormalities,
hypokalemia, and hypertension. These toxicities are manageable with interventions,
including proactive laboratory monitoring, dose interruptions, and dose reductions, if
needed. Data from sponsor Study 64091742PCR1001 and 64091742PCR3001 (see
Section 2.2.3) show that niraparib 200 mg and AAP may be combined safely.46 This
protocol includes a targeted monitoring plan and treatment guidelines to ensure appropriate
management of the overlapping toxicities of niraparib and AAP, including hypertension,
liver function abnormalities, and hypokalemia (see Section 6.5). In addition, participants
are required to have specified laboratory values in the inclusion criteria (see Section 5.1)
and uncontrolled hypertension and known active hepatitis B and active hepatitis C are
included as exclusion criteria (see Section 5.2). As noted in the SoA, blood pressure, heart
rate, potassium, and liver function tests will be monitored through EoT.
 PK data from Study 64091742PCR1001 also show that exposures for both niraparib and
AA are comparable to when each drug is administered as a single agent.46
 Treatment-emergent AEs and other safety data for the study will be monitored by the
Independent Data Monitoring Committee (IDMC) and the sponsor’s medical monitor and
internal safety management committee during the conduct of the study, as described
throughout this protocol.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
27
Status: Approved, Date: 28 August 2023
 The benefit-risk profile of the niraparib/AA FDC tablets is expected to be the same as for
niraparib and AA administered as single agents.
Given that the data suggest that there is a potential for increased efficacy for the combination of
niraparib and AA plus prednisone in patients with deleterious germline or somatic HRR
gene-mutated metastatic prostate cancer and that the anticipated toxicities of niraparib and AA
plus prednisone are recognizable through medical oversight and laboratory monitoring and are
able to be managed medically, the sponsor considers that there is a positive benefit/risk profile and
strong rationale for evaluating niraparib and AA plus prednisone for the treatment of patients with
mCSPC.
Taking into account the measures incorporated to minimize risk to participants of this study, the
potential risks identified in association with niraparib/AA FDC, niraparib and AA, plus prednisone
are justified by the anticipated benefits that may be afforded to participants with mCSPC.
By-gene analysis from Study 64091742PCR3001 showed no clear evidence of benefit of niraparib
combined with AAP in patients with CDK12 alterations.48 While clinical benefit could not be
excluded, given the distinct biology in CDK12-altered prostate cancer, as well as other emerging
data suggesting limited efficacy of PARP inhibition in this group of patients, participants with
CDK12-only alterations are no longer being enrolled in Study 67652000PCR3002.
More detailed information about the known and expected benefits and risks of niraparib and AA
may be found in the niraparib, AA, and niraparib/AA FDC IBs24,25,26 as well as in the latest version
of the package insert for ZEJULA® (niraparib), ZYTIGA® (AA) and prednisone, that is applicable
for the local country in which the study is being conducted.
3. 
OBJECTIVES AND ENDPOINTS
Objectives 
Endpoints
Primary
 
To determine if niraparib and AA, plus prednisone
compared with AA plus prednisone in participants with
deleterious germline or somatic HRR gene-mutated
mCSPC provides superior efficacy in improving rPFS
 
rPFS by investigator (based on
PCWG3)
Secondary
 
To assess the clinical benefit of niraparib and AA, plus
prednisone compared with AA plus prednisone in
participants with deleterious germline or somatic HRR
gene-mutated mCSPC
 
OSa
 
Time to symptomatic progressionb
 
Time to subsequent therapyc
 
To characterize the safety profile of niraparib and AA,
plus prednisone compared with AA plus prednisone in
participants with deleterious germline or somatic HRR
gene-mutated mCSPC
 
Incidence and severity of adverse
events

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
28
Status: Approved, Date: 28 August 2023
Objectives 
Endpoints
Other
 
To evaluate other efficacy assessments and determine
the clinical benefit of niraparib and AA, plus
prednisone compared with AA plus prednisone in
participants with deleterious germline or somatic HRR
gene-mutated mCSPC
 
PFS2d
 
Objective responsee
 
Time to PSA progressionf
 
To characterize the PK of niraparib when administered
as niraparib/AA FDC plus prednisone
 
Observed plasma concentrations of
niraparib and estimated population
PK and exposure parameters for
niraparib
 
To show the effect of niraparib and AA, plus
prednisone is similar to AA plus prednisone on health-
related quality of life
 
The FACT-P, the EQ-5D-5L, BPI-SF,
and the PRO-CTCAE
 
To evaluate biomarkers predictive of response 
 
Objective response, rPFS, and PSA
response across deleterious germline
or somatic HRR gene alterations
AA=abiraterone acetate; BPI-SF=Brief Pain Inventory Short Form; CDK12=cyclin dependent kinase 12;DR=EQ-
5D-5L=Euro Quality of Life questionnaire; FACT-P=Functional Assessment of Cancer Therapy-Prostate;
PRO-CTCAE= Patient-reported Outcomes Common Terminology Criteria for Adverse Events; FDC=fixed-dose
combination; HRR=homologous recombinant repair; mCSPC=metastatic castration-sensitive prostate cancer;
OS=overall survival; PCWG3=Prostate Cancer Working Group 3; PFS2=progression-free survival 2;
PK=pharmacokinetic; PSA=prostate-specific antigen; rPFS=radiographic progression-free survival;
RECIST=Response Evaluation Criteria in Solid Tumors
a. OS: defined as the time from date of randomization to date of death due to any cause.
b. Time to symptomatic progression is defined as time from the date of randomization to the date of any of the
following (whichever occurs first):
-The use of external beam radiation therapy for skeletal or pelvic symptoms. Note: Only radiation planned
prior to randomization will not be considered as symptomatic progression
-The need for tumor-related orthopedic surgical intervention
-Other cancer-related procedures (eg, nephrostomy insertion, bladder catheter insertion, external beam
radiation therapy, or surgery for tumor symptoms)
-Cancer-related morbid events (ie, fracture [symptomatic and/or pathologic], cord compression, urinary
obstructive events)
-Initiation of a new systemic anti-cancer therapy because of cancer symptoms.
c. Time to Subsequent Therapy: defined as the time from date of randomization to the date of initiation of
subsequent therapy for prostate cancer.
d. PFS2: defined as time from date of randomization to date of first occurrence of disease progression
(radiographic, clinical, or PSA progression) on first subsequent therapy for prostate cancer or death, whichever
comes first.
e. Objective response: defined as achieving a complete or partial response according to modified RECIST 1.1
f. Time to PSA progression: defined as the time from the date of randomization to the date of PSA progression
based on PCWG3 criteria.
Refer to Section 8, Study Assessments and Procedures for evaluations related to endpoints.
HYPOTHESIS
The primary hypothesis of this study is that niraparib and AA, plus prednisone will improve rPFS
compared with AA plus prednisone in participants with deleterious germline or somatic HRR
gene-mutated mCSPC.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
29
Status: Approved, Date: 28 August 2023
4. 
STUDY DESIGN
4.1. 
Overall Design
This is a randomized, placebo-controlled, double-blind, multinational Phase 3 treatment study to
evaluate the safety and efficacy of niraparib and AA, plus prednisone compared with AA plus
prednisone in men over the age of 18 years with deleterious germline or somatic HRR
gene-mutated mCSPC receiving ADT (ie, gonadotropin-releasing hormone analogue [GnRHa;
agonist or antagonist] or surgical castration).
Approximately 692 participants will be randomly assigned in a 1:1 ratio to either niraparib 200 mg
and AA 1000 mg, plus prednisone 5 mg daily or AA 1000 mg plus prednisone 5 mg daily
(Figure 1). All participants will be receiving background ADT therapy, the choice of which is at
the discretion of the investigator. Participants will be stratified based on BRCA2 and CDK12 status
(BRCA2 alteration present versus CDK12 alteration present versus all other pathogenic
alterations), prior docetaxel use (yes versus no), and volume of disease (high versus low). The
study will consist of 4 phases: a Prescreening Phase for biomarker evaluation for eligibility only,
a Screening Phase, a Treatment Phase, and a Follow-up Phase.
Efficacy evaluations include the following: tumor measurements by computed tomography (CT),
magnetic resonance imaging (MRI; abdomen, chest, and pelvis), Technetium-99m (99mTc) bone
scans, serum PSA evaluations, and patient reported outcomes (PROs). Plasma levels of niraparib
and its M1 metabolite will be assessed. Safety evaluations include incidence of AEs and clinical
laboratory parameters.
Participants receive study medication in 28-day treatment cycles. Study medication should
continue until disease progression, unacceptable toxicity, death, withdrawal of consent, or
termination of the study by the sponsor (see Section 7.1). Patients with radiographic progression
can remain on therapy if still receiving clinical benefit. Imaging will be performed at Day 1 of
Cycle 3, Cycle 5, and then every 4 cycles. If the participant has radiographic progression, but not
clinical progression, and alternate treatment is not initiated, the participant may continue study
medication at the investigator’s discretion.
After discontinuing study medication, participants will be contacted every 4 months until death or
termination of the study. Participants who discontinue study medication prior to reaching the
primary endpoint of rPFS will continue to be scanned until reaching the primary endpoint. In
addition to survival follow-up, data will continue to be collected to evaluate all of the secondary
and other endpoints. The Euro-Quality of Life Questionnaire (EQ-5D-5L) will also be
administered every 4 months for up to 1 year after study medication discontinuation.
Participants will be monitored for safety during the Prescreening, Screening, and Treatment Phases
and up to 30 days after the last dose of study medication during the Follow-up Phase. Adverse
events, including clinically significant laboratory abnormalities reported as AEs, will be graded
and summarized using National Cancer Institute Common Terminology Criteria for Adverse
Events (NCI-CTCAE), Version 5. Dose modification guidelines are provided in Section 6.5.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
30
Status: Approved, Date: 28 August 2023
An IDMC will be commissioned for this study and will perform regular review of safety data.
Refer to Committees Structure in Section 10.2, Appendix 2, Regulatory, Ethical, and Study
Oversight Considerations for details.
A diagram of the study design is provided in Figure 1.
4.2. 
Scientific Rationale for Study Design
Blinding, Control, Study Phase/Periods, Treatment Groups
An active control will be used in this study. Randomization will be used to minimize bias in the
assignment of participants to treatment groups, to increase the likelihood that known and unknown
participant attributes (eg, demographic and baseline characteristics) are evenly balanced across
treatment groups, and to enhance the validity of statistical comparisons across treatment groups.
Blinded treatments will be used to reduce potential bias during data collection and evaluation of
clinical endpoints.
The control for this study is AA 1000 mg plus prednisone 5 mg daily.
As treatment options for men with mCSPC include docetaxel, prior docetaxel will be permitted,
and prior docetaxel is a stratification factor to ensure balance of this prior therapy between the
arms.
Biomarker Collection
Participants enrolled in this study must have demonstrated at least one deleterious germline or
somatic HRR gene alteration as listed in Table 4. Adjustments regarding the inclusion of
participants with specific deleterious germline or somatic HRR gene alterations may be made
based on evidence from emerging data or to ensure enough participants are enrolled to allow for
subgroup analysis. Any biomarker-related enrollment changes will be communicated to
investigators.
During the Prescreening Phase, participants will be evaluated for HRR gene alterations (see
Table 4 for definition of biomarker-positivity). All participants will be required to sign an ICF.
After signing the ICF, all participants should have (a) tumor tissue (archival or recently
collected), and (b) germline (eg. blood, saliva), and also (c) plasma samples collected (if test is
available from the sponsor) (Table 1).
In lieu of prescreening, prior local HRR testing performed in a Clinical Laboratory Improvement
Amendment-certified (CLIA) or equivalent laboratory may be used. Sponsor must approve
participant’s HRR alteration status prior to randomization based on receipt of a redacted
biomarker report(s).
The type of samples, testing methodology, and gene alterations used to determine eligibility may
be updated by the sponsor, with changes communicated to investigators by letter. All participants
will have additional exploratory research samples collected where local regulations allow. Local

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
31
Status: Approved, Date: 28 August 2023
tests may be performed using tumor tissue, plasma, or germline sample. Randomized participants
that submitted a local result should submit tissue unless the local test result was from the
sponsor’s required tissue assay.
For tumor tissue collection, either archival or recently collected tissue is acceptable. If no tumor
tissue is available, then the participant may agree to have a new tumor tissue sample collected. If
the sample used to determine eligibility fails to produce a conclusive result, then another sample
may be assessed.
Table 4: 
Eligible HRR Gene Alterations
Genes 
Definition
BRCA1 
Breast Cancer gene 1
BRCA2 
Breast Cancer gene 2
BRIP1 
BRCA1 Interacting Protein C-terminal Helicase 1 gene
CDK12 
Cyclin Dependent Kinase 12
CHEK2 
Checkpoint Kinase 2 gene
FANCA  
Fanconi Anemia Complementation Group A gene
PALB2 
Partner and Localizer of BRCA2 gene
RAD51B  
RAD51 paralog B
RAD54L 
RAD54-Like
In addition to determining participant eligibility, exploratory research samples will be collected at
timepoints outlined in the SoA as local regulations permit and may be evaluated to understand
response or resistance in participants, to evaluate surrogates of tumor burden or to further develop
diagnostic tests.
Medical Resource Utilization Data Collection
Treatment of mCSPC with niraparib and AA, plus prednisone versus AA plus prednisone may
result in a higher number or duration of medical encounters; therefore, comparison will be done
across treatment groups.
4.2.1. Participant Input into Design
Qualitative research including 43 patients with metastatic prostate cancer has been performed in
order to understand patients’ perceptions of clinical studies in general, study concept, and
opportunities for improving study concept and study adherence. A mixed methodology of
mini-groups, an on-line community, and web-assisted telephone interviews was used. Patients
included clinical study naïve patients (n=35) and clinical study experienced patients (n=8) and
were recruited from different regions (US and Canada n=17, Europe n=6, South America n=6,
Asia Pacific n=6).
Results included patients’ perception that the study process is burdensome and difficult for them
to comply with; they are more willing to accept treatment requirements but have concerns about

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
32
Status: Approved, Date: 28 August 2023
pre- and post-treatment phases. Based on this insight, during the follow-up phase, the visits can be
performed by phone.
4.2.2. Study-Specific Ethical Design Considerations
The potential benefits of treatment with niraparib and AA, plus prednisone in men with metastatic
prostate cancer, both with prospectively selected deleterious germline or somatic HRR gene
alterations, outweighs the potential risks involved as described in Section 2.3.
Potential participants will be fully informed of the risks and requirements of the study and, during
the study, participants will be given any new information that may affect their decision to continue
participation. They will be told that their consent to participate in the study is voluntary and may be
withdrawn at any time with no reason given and without penalty or loss of benefits to which they
would otherwise be entitled. Only participants who are fully able to understand the risks, benefits,
and potential AEs of the study, and provide their consent voluntarily will be enrolled.
All participants will receive full supportive care and will be followed closely for safety and
efficacy throughout the study. As rPFS is the primary endpoint, scheduled imaging is incorporated
into the protocol. The timing of imaging is designed to capture progression events and allow the
clinical investigator to make timely treatment decisions yet balancing this with preventing
unnecessary exposure to radiation. The frequency of scanning is consistent with the internationally
accepted Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and Prostate Cancer
Working Group 3 (PCWG3) criteria. An IDMC will be commissioned for this study and will
perform regular review of safety data. Refer to Committees Structure in Section 10.2, Appendix 2,
Regulatory, Ethical, and Study Oversight Considerations for details.
As with all clinical and PK studies, there are risks associated with venipuncture and multiple blood
sample collections. To avoid multiple venipunctures, the use of intravenous indwelling catheters
is permitted in this study. The blood sample collection scheme will be designed to collect the
minimum number of blood samples that can determine the safety, antitumor activity, PK,
pharmacodynamics, and biomarker requirements of the study. Note that the total volume of blood
to be collected (approximately 1500 mL) is an estimate (see Section 8); the actual amount may
vary depending on laboratory standard procedures and the number of days a participant is enrolled
in the study. The total blood volume to be collected is considered to be an acceptable amount of
blood to be collected over this time period from the population in this study based upon the standard
of the WHO guidelines which suggest a standard donation of 450 mL of whole blood and a
maximum volume of 3 L donated in any consecutive 12-month period.56 For more details regarding
blood collection, see Section 8.
The results of genetic testing done as part of this study could have implications to family members
of the participant. The investigator will arrange for genetic counseling as needed.
4.3. 
Justification for Dose
The dose of niraparib in this study is 200 mg administered with AA 1000 mg in combination with
prednisone 5 mg; all study medications are administered once daily.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
33
Status: Approved, Date: 28 August 2023
As described in Section 2.2.3, in study 64091742PCR1001 niraparib 200 mg was selected to be
the optimal dose to be combined with AAP based on the absence of dose-limiting toxicities and
an overall tolerable safety profile. No drug-drug interaction has been detected between AAP and
niraparib. The safety of niraparib in combination with AAP was further confirmed in the primary
analysis of Study 64091742PCR3001.
Based on the above information, a dose of niraparib 200 mg once daily has been selected for this
combination study to maximize efficacy, while mitigating the potential for toxicity.
Dose modifications are addressed in Section 6.5.
4.4. 
End of Study Definition
End of Study Definition
The end of study is considered as the last scheduled study assessment for the last participant in the
study, including the Open-label Extension (OLE) and Long-term Extension (LTE) Phases, as
applicable. The final data from the study site will be sent to the sponsor (or designee) after
completion of the final participant assessment at that study site, in the time frame specified in the
Clinical Trial Agreement.
Study Completion Definition
A participant will be considered to have completed the Treatment and Follow-up Phase when a
clinical endpoint is reached (death, radiographic progression, clinical progression, or unacceptable
toxicity, whichever comes first). All participants will be followed for survival.
5. 
STUDY POPULATION
Men >18 years of age (or the local legal age of consent) with deleterious germline or somatic HRR
gene-mutated metastatic prostate cancer (see Section 4.2, Scientific Rationale for Study Design,
Biomarker Collection) are eligible for this study. Prescreening activities to determine biomarker
status may occur any time prior to the Screening Phase.
The inclusion and exclusion criteria for enrolling participants in this study are described below. If
there is a question about these criteria, the investigator must consult with the appropriate sponsor
representative and resolve any issues before enrolling a participant in the study. Waivers are not
allowed.
For a discussion of the statistical considerations of participant selection, refer to Section 9.2,
Sample Size Determination.
Prescreening for Molecular Eligibility
Molecular eligibility will be established for each potential participant before screening for other
eligibility criteria (Figure 2).

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
34
Status: Approved, Date: 28 August 2023
Figure 2. 
Determination of Molecular Eligibility
Prescreening Eligibility Criteria For Participants Who Do Not Have Prior Results Available
from Either a Local Test or Sponsor’s Commercial Tumor Tissue Test:
1. 
Criterion modified per Amendment 3
1.1 Prescreening informed consent obtained.
2. 
≥18 years of age (or the local legal age ofconsent).
3. 
Criterion modified per Amendment 2.
3.1. 
Diagnosis ofmetastatic prostate adenocarcinoma.
4. 
Criterion modified per Amendment 1.
4.1. Criterion modified per Amendment 2
4.2. 
Willing to provide tumor tissue (archival or fresh), blood or saliva, and plasma (if
test is available from the sponsor) for determination of deleterious germline or somatic
HRR gene alterations (see Table 4), if no local (testing done at investigator center or
commercial testing) or prior sponsor-approved test result is available (see Figure 2).

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
35
Status: Approved, Date: 28 August 2023
5.1. 
Inclusion Criteria
Each potential participant must satisfy all of the following criteria to be enrolled in the study:
1. 
>18 years of age (or the local legal age of consent).
2. 
Criterion modified per Amendment 2.
2.1. Pathological diagnosis of prostate adenocarcinoma.
3. 
Criterion deleted per Amendment 1.
4. 
Criterion modified per Amendment 2.
4.1. Metastatic disease documented by conventional imaging with CT or MRI (for soft
tissue lesions) or 99mTc bone scan (for bone lesions). Participants with a single bone
lesion on 99mTc bone scan with  no other non-nodal metastatic disease must have
confirmation of bone metastasis by CT or MRI.
a. Participants with lymph node-only disease are not eligible.
5 
Criterion modified per Amendment 1.
5.1. Must have at least one of the deleterious germline or somatic HRR gene alterations
listed in Table 4.
6. 
Eastern Cooperative Oncology Group Performance Status (ECOG PS) Grade <2.
7. 
Androgen deprivation therapy (either medical or surgical castration) must have been
started >14 days prior to randomization and participants be willing to continue ADT
through the treatment phase. Participants who start a GnRH agonist <28 days prior to
randomization will be required to take a first-generation anti-androgen for >14 days prior
to randomization. The anti-androgen must be discontinued prior to randomization.
8. 
Criterion modified per Amendment 1.
8.1. Criterion modified per Amendment 2.
8.2. Participants who have received prior docetaxel treatment must meet the following
criteria:
a. 
Received a maximum of 6 cycles of docetaxel therapy for mCSPC
b. 
Received the last dose of docetaxel ≤3 months prior to randomization
c. 
Maintained a response to docetaxel of stable disease or better, by investigator
assessment of imaging and/or PSA, prior to randomization.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
36
Status: Approved, Date: 28 August 2023
9. 
Criterion modified per Amendment 1.
9.1. Criterion modified per Amendment 2.
9.2. Other allowed prior therapy for mCSPC:
a. 
Maximum of 1 course of radiation and 1 surgical intervention for symptomatic
control of prostate cancer (eg, uncontrolled pain, impending spinal cord
compression or obstructive symptoms). Participants with radiation or surgical
interventions to all known sites of metastatic disease will be excluded from trial
participation. Radiation must be completed prior to randomization.
b. 
Up to a maximum of 6 months of ADT prior to randomization.
c. 
Up to a maximum of 45 days of AAP prior to randomization.
d. 
Up to a maximum of 2 weeks of ketoconazole for prostate cancer prior to
randomization.
10. 
Criterion modified per Amendment 2.
10.1. Allowed prior treatments for localized prostate cancer include radical prostatectomy
(with or without lymph node dissection), radiation therapy, and other locally directed
treatments to the prostate per institutional standards of care.
a. 
Participants who received ADT or first-generation anti-androgens for the treatment
of localized prostate cancer
i. 
ADT: must have had < 3 years total and must have completed ≥1 year prior
to randomization
ii. 
First-generation anti-androgen: must have had ≤3 years total and must
have completed ≥1 year prior to randomization.
11. 
Criterion modified per Amendment 1.
11.1. Clinical laboratory values at Screening:
a. 
Absolute neutrophil count ≥1.5 x 109/L
b. 
Hemoglobin ≥9.0 g/dL, independent of transfusions for at least 28 days
c. 
Platelet count ≥100 x 109/L
d. 
Creatinine <2 x upper limit of normal (ULN)
e. 
Serum potassium ≥3.5 mmol/L
f. 
Serum total bilirubin ≤1.5× ULN or direct bilirubin ≤1 x ULN (Note: In participants
with Gilbert’s syndrome, if total bilirubin is >1.5 × ULN, measure direct and
indirect bilirubin, and if direct bilirubin is ≤1.5 × ULN, participant may be eligible)
g. 
AST or ALT ≤3 × ULN
12. 
Able to swallow the study medication tablets whole.
13. 
Criterion modified per Amendment 1.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
37
Status: Approved, Date: 28 August 2023
13.1. Must sign informed consent (written or remote/virtual) indicating that he
understands the purpose of, and procedures required for, the study and is willing to
participate in the study including providing a DNA sample.
14. 
Criterion modified per Amendment 1
14.1. While on study medication and for 3 months following the last dose of study
medication, a male participant must agree to use an adequate contraception method as
deemed appropriate by the investigator and as specified in Section 5.3. Lifestyle
Considerations.
15. 
Criterion modified per Amendment 1
15.1. A male participant must agree not to donate sperm while on study treatment and for
a minimum of 3 months following the last dose of study medication.
5.2. 
Exclusion Criteria
Any potential participant who meets any of the following criteria will be excluded from
participating in the study:
1. 
Pathological finding consistent with small cell or neuroendocrine carcinoma of the
prostate.
2. 
Prior treatment with a PARP inhibitor.
3. 
Criterion modified per Amendment 1.
3.1. Criterion modified per Amendment 2.
3.2. Prior AR-targeted therapy  (eg, apalutamide, enzalutamide, darolutamide),
immunotherapy, or radiopharmaceutical agents for prostate cancer with the Exception:
allowed prior therapies are noted in inclusion criteria 9.2.
4. 
Criterion deleted per Amendment 2.
5. 
History of adrenal dysfunction
6. 
Long-term use of systemically administered corticosteroids (>5 mg of prednisone or the
equivalent) during the study is not allowed. Short-term use (≤4 weeks, including taper)
and locally administered steroids (eg, inhaled, topical, ophthalmic, and intra-articular)
are allowed, if clinically indicated.
7. 
 Active malignancies (ie, progressing or requiring treatment change in the last
24 months) other than the disease being treated under study. The only allowed
exceptions are:
a. non-muscle invasive bladder cancer;
b. skin cancer (non-melanoma or melanoma) treated within the last 24 months that
is considered completely cured;

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
38
Status: Approved, Date: 28 August 2023
c. breast cancer –adequately treated lobular carcinoma in situ or ductal carcinoma
in situ;
d. malignancy that is considered cured with minimal risk of recurrence.
8. 
History or current diagnosis of MDS/AML.
9. 
Current evidence within 6 months prior to randomization of any of the following:
severe/unstable angina, myocardial infarction, symptomatic congestive heart failure,
clinically significant arterial or venous thromboembolic events (ie. pulmonary
embolism), or clinically significant ventricular arrhythmias.
10. 
Presence of sustained uncontrolled hypertension (systolic blood pressure >160 mm Hg
or diastolic blood pressure >100 mm Hg). Participants with a history of hypertension
are allowed, provided that blood pressure is controlled to within these limits by an anti-
hypertensive treatment.
11. 
Known allergies, hypersensitivity, or intolerance to the excipients of niraparib, AA, or
niraparib/AA FDC (refer to the IBs for niraparib and AA).24,25,26
12. 
Current evidence of any medical condition that would make prednisone use
contraindicated.
13. 
Received an investigational intervention (including investigational vaccines) or used an
invasive investigational medical device within 30 days before the planned first dose of
study medication.
14. 
Participants who have had the following ≤28 days prior to randomization:
a. A transfusion (platelets or red blood cells);
b. Hematopoietic growth factors;
c. Major surgery (sponsor should be consulted regarding what constitutes major
surgery).
15. 
Criterion was deleted per Amendment 1
16. 
Human immunodeficiency virus positive participants with 1 or more of the following:
a. Not receiving highly active antiretroviral therapy or on antiretroviral therapy for
less than 4 weeks.
b. Receiving antiretroviral therapy that may interfere with the study medication
(consult the sponsor for review of medication prior to enrollment).
c. A change in antiretroviral therapy within 6 months of the start of screening (except
if, after consultation with the sponsor on exclusion criterion 16.b, a change is made
to avoid a potential drug-drug interaction with the study medication).
d. CD4 count <350 at screening.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
39
Status: Approved, Date: 28 August 2023
e. An acquired immunodeficiency syndrome-defining opportunistic infection
within 6 months of the start of screening.
f. Human immunodeficiency virus load >400 copies/mL.
17. 
Active or symptomatic viral hepatitis or chronic liver disease; encephalopathy, ascites
or bleeding disorders secondary to hepatic dysfunction.
18. 
Criterion modified per Amendment 2.
18.1. Moderate or severe hepatic impairment (Class B and C per Child-Pugh
classification system (Appendix 9).
NOTE: Investigators should ensure that all study enrollment criteria have been met at screening.
If a participant's clinical status changes (including any available laboratory results or receipt of
additional medical records) after screening but before the first dose of study medication is given
such that he no longer meets all eligibility criteria, then the participant should be excluded from
participation in the study. Section 5.4, Screen Failures, describes options for retesting. The
required source documentation to support meeting the enrollment criteria are noted in Section 10.2,
Appendix 2, Regulatory, Ethical, and Study Oversight Considerations.
5.3. 
Lifestyle Considerations
Potential participants must be willing and able to adhere to the following lifestyle restrictions
during the course of the study to be eligible for participation:
1. 
Refer to Section 6.8 for details regarding prohibited and restricted therapy during the
study.
2. 
Agree to follow all requirements that must be met during the study as noted in the
Inclusion and Exclusion Criteria (eg, contraceptive requirements).
3. 
Must agree to always use a condom during sexual intercourse (even in case of prior
vasectomy or in case of intercourse with an already pregnant woman) or to remain
abstinent during the study and for 3 months after the last study treatment administration
(Section 7.1 Discontinuation of Study Medication).
If the participant is engaged in sexual activity with a woman of childbearing potential,
then a condom should be used along with another highly effective contraceptive
method. Highly effective methods of contraception (methods that can achieve a failure
rate of less than 1% per year when used consistently and correctly) include:
 combined hormonal (estrogen + progesterone or progesterone only)
contraception associated with inhibition of ovulation: oral, injectable or
implantable;

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
40
Status: Approved, Date: 28 August 2023
 placement of an intrauterine device (IUD) or intrauterine hormone releasing
system (IUS);
 bilateral tubal occlusion;
 vasectomy;
 sexual abstinence; please note that sexual abstinence is considered a highly
effective method only if defined as refraining from heterosexual intercourse
during the entire period of risk associated with the study treatments. The
reliability of sexual abstinence needs to be evaluated in relation to the duration
of the clinical trial and the preferred and usual lifestyle of the participant.
A highly effective contraceptive method should be used for the duration of the study
and for 3 months after the last study medication administration.
5.4. 
Screen Failures
Participant Identification, Enrollment, and Screening Logs
The investigator agrees to complete a participant identification and enrollment log to permit easy
identification of each participant during and after the study. This document will be reviewed by
the sponsor study-site contact for completeness. This study will use interactive web response
system (IWRS). The investigator will generate screening and enrollment logs directly from IWRS.
The participant identification and enrollment log will be treated as confidential and will be filed
by the investigator in the study file. To ensure participant confidentiality, no copy will be made.
All reports and communications relating to the study will identify participants by participant
identification and age at initial informed consent. In cases where the participant is not randomized
into the study, the date seen and age at initial informed consent will be used.
Participants who do not meet all inclusion criteria, or who meet an exclusion criterion, may be
rescreened once. Rescreening is at the discretion of the investigator. After discussion with the
sponsor, rescreened participants may be able to use the initial screening laboratory results as long
as safety laboratory evaluations (hematology panel, serum chemistry panel, and liver function tests
[LFTs]) described in Section 8.2.4 have been performed within 14 days of randomization. Initial
CT/MRI and bone scans may be used to determine eligibility if within 6 weeks of planned
randomization. All other rescreening and subsequent randomization activities must be conducted
in accordance with all protocol defined windows and timelines. The sponsor or designee will
review results from the screening visit prior to randomization to confirm participant selection for
the study.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
41
Status: Approved, Date: 28 August 2023
6. 
STUDY MEDICATION AND CONCOMITANT THERAPY
6.1. 
Study Medication(s) Administered
Designation 
Product
Investigational Medicinal Products 
Niraparib
AA
Niraparib/AA FDC tablets*
Matching placebo for the above IMPs.
Status in EU: product will be used in accordance with the
terms of their marketing authorization.
*not authorized for the indication investigated in this study.
Authorized Auxiliary Medicinal
Product
Androgen-deprivation therapy: GnRHa such as leuprolide,
goserelin, histrelin, triptorelin, degarelix, relugolix
(ATC: L02AE and L02BX).
Prednisone/prednisolone.
Status in the EU: product will be used in accordance with
the terms of their marketing authorization.
Authorized Diagnostic Auxiliary
Medicinal Product
Tracers used for bone scans such as 99mTc (ATC: V09I).
Status in the EU: product will be used in accordance with
the terms of their marketing authorization.
99mTc=technetium-99m; AA=abiraterone acetate; ATC=Anatomical Therapeutic Chemical; EU=European Union;
FDC=fixed-dose combination; GnRHa=gonadotropin-releasing hormone analogue; IMP=investigational medicinal
product
For the purpose of the study, “study medication” refers to niraparib, AA, Fixed Dose Combination
(niraparib+AA), matching placebos and prednisone.
6.1.1. ADT Administration
Continuous treatment with a GnRHa (if not previously surgically castrated) is mandatory for all
participants. The choice of GnRHa is at the discretion of the investigator. Dose and dose schedule
(without interruption) will be consistent with the prescribing information and should only be
adjusted if clinically indicated to maintain castrate concentrations of testosterone. For participants
who did not undergo surgical castration, concurrent treatment with a GnRHa must be documented
in the electronic case report form (eCRF).
6.1.2. Study Medication
Study medication is administered orally, once daily on an outpatient basis. A treatment cycle is
defined as 28 days. Further details regarding how study medications are supplied are described in
Table 5, Table 6, and Table 7. Sufficient study medication for each treatment cycle will be
distributed on the first day of each cycle. Participants will begin taking study medication on Day 1
of Cycle 1. If a participant forgets to take the study medication, then the missed dose(s) should
only be replaced within the same day.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
42
Status: Approved, Date: 28 August 2023
Participants will be randomized to 1 of 2 treatments groups:
 niraparib 200 mg and AA 1000 mg, plus prednisone 5 mg daily (Experimental)
 AA 1000 mg plus prednisone 5 mg daily (Control)
Matching placebos will also be administered.
Participants randomized to receive niraparib and AA plus prednisone will receive 2 niraparib/AA
regular-strength FDC tablets (100 mg niraparib/500 mg AA per tablet), 4 AA placebo tablets, plus
5 mg prednisone.
Participants randomized to receive AA plus prednisone will receive placebo corresponding to
2 FDC tablets (containing neither niraparib nor AA), 4 AA tablets (250 mg each), plus 5 mg
prednisone.
A low strength FDC tablet containing 50 mg niraparib/500 mg AA is available for participants
requiring a dose reduction of niraparib.
If a dose reduction is required that cannot be supplied using a FDC tablet, equivalent single-agent
medication will be supplied.
For treatment modifications due to toxicities, see Section 6.5. For dose modification, see
single-agent formulations in Table 6 and low strength FDC formulations in Table 7.
For special dosing instructions during PK visits, see Section 6.1.3.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
43
Status: Approved, Date: 28 August 2023
Table 5: 
Description of Study Medications
Arm Name 
Niraparib/AA plus Prednisone 
AA plus Prednisone
Study 
Medication 
Name
Niraparib/AA 
FDC
Placebo AA  
Prednisone⁎ 
Placebo FDC  
AA  
Prednisone
Type 
Combination 
product 
containing 2
drugs
Drug - 
placebo
Drug 
Drug –placebo Drug 
Drug
Dose 
Formulation  
FDC film-coated 
tablet 
tablet 
tablet 
FDC film- 
coated tablet
tablet 
tablet
Unit Dose 
Strength(s) 
regular-strength 
FDC 100 mg 
niraparib/500 mg 
AA per tablet
250 mg AA 
placebo 
5 mg 
prednisone 
per tablet 
regular- 
strength FDC 
placebo 
250 mg AA 
per tablet 
5 mg
prednisone
per tablet
Dosage Level(s) 
2 tablets of 
regular-strength 
FDC: 100 mg 
niraparib/ 500 mg 
AA (total dose = 
200 mg niraparib/
1000 mg AA)
once daily
4 tablets of 
placebo once 
daily  
1 tablet 
(5 mg) once 
daily  
2 tablets of 
regular- 
strength FDC 
placebo once 
daily
4 tablets (total 
dose = 
1000 mg AA) 
once daily
1 tablet
(5 mg) once
daily
Route of 
Administration
oral 
oral 
oral 
oral 
oral 
oral
Sourcing 
Provided 
centrally by the 
sponsor 
Provided 
centrally by 
the sponsor 
Provided
locally by the
study site,
subsidiary, or
designee
Provided 
centrally by 
the sponsor 
Provided
centrally by
the sponsor
Provided
locally by the
study site,
subsidiary, or
designee
Packaging and
Labeling
(Labels will
contain
information to
meet the
applicable
regulatory
requirements)
high-density
polyethylene
bottles with
child-resistant
closure
high-density
polyethylene
bottles with
child-resistant
closure.
as provided
locally by the
study site,
subsidiary, or
designee
high-density
polyethylene
bottles with
child-resistant
closure.
high-density
polyethylene
bottles with
child-resistant
closure
as provided
locally by the
study site,
subsidiary, or
designee
Delivery
Instructions
See Section 6.1.3 for special directions for PK visits
Food/Fasting
Requirement
Take on an empty stomach. No food should be consumed for at least 2 hours before and for at least 1 hour
after dosing for study drug except Prednisone.
*Prednisolone may be administered in countries where prednisone is not available.
-Prednisone/Prednisolone should be taken along with food.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
44
Status: Approved, Date: 28 August 2023
Table 6: 
Single-Agent Formulations
Study Medication Name 
Niraparib 
Placebo for 
Niraparib
AA  
Placebo for AA
Type 
drug 
drug - placebo 
drug 
drug - placebo
Dose Formulation 
capsule or 
tablet*
capsule 
tablet 
tablet
Unit Dose Strength 
100 mg per 
capsule or 
tablet*
placebo 
250 mg per 
tablet
placebo
Dosage Level(s) 
100 mg or 
200 mg once 
daily –see 
Section 6.5 
once daily  
500 mg or 
1000 mg once
daily –see
Section 6.5
once daily
Route of Administration 
oral 
oral 
oral 
oral
Sourcing 
Provided 
centrally by the 
sponsor 
Provided 
centrally by the 
sponsor 
Provided 
centrally by the 
sponsor
Provided centrally by
the sponsor
Packaging and Labeling 
(Labels will contain
information to meet the
applicable regulatory
requirements)
high-density polyethylene bottles with child-resistant closure
Food/Fasting Requirement 
Take on an empty stomach. No food should be consumed for at least 2 hours
before and for at least 1 hour after dosing
Note: In the event the FDC formulation is not available, single-agent formulations will be used.
*Niraparib tablet may only be used during the Open-label Extension/Long-term Extension Phase after regulatory approval in the
jurisdiction as applicable.
Table 7: 
Low-strength niraparib FDC Formulations for Use When Dose Modification is Required and
When Available
Study Medication Name 
Low-strength niraparib/AA FDC  
Low-strength placebo FDC
Type 
Combination product containing 2 
drugs
Drug - placebo
Dose Formulation 
FDC film-coated tablet 
FDC film-coated tablet
Unit Dose Strength(s) 
low-strength FDC: 50 mg 
niraparib/500 mg AA per tablet
low-strength FDC: placebo
Dosage Level(s) 
2 tablets of low-strength FDC 50 mg 
niraparib/500 mg AA FDC (total dose 
= 100 mg niraparib/1000 mg AA)
once daily
2 tablets of low-strength FDC
placebo once daily
Route of Administration 
oral 
oral
Sourcing 
Provided centrally by the sponsor 
Provided centrally by the sponsor
Packaging and Labeling 
(Labels will contain 
information to meet the
applicable regulatory
requirements)
high-density polyethylene bottles with 
child resistant closure 
high-density polyethylene bottles
with child resistant closure
Delivery instructions 
See Section 6.1.3 for special 
directions for PK visits 
See Section 6.1.3 for special
directions for PK visits
Food/Fasting Requirement 
Take on an empty stomach. No food 
should be consumed for at least 
2 hours before and for at least 1 hour 
after dosing. 
Take on an empty stomach. No food
should be consumed for at least
2 hours before and for at least 1 hour
after dosing.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
45
Status: Approved, Date: 28 August 2023
Study medication administration must be captured in the source documents and the eCRF. Study-
site personnel will instruct participants on how to store study medication for at-home use as
indicated for this protocol.
Niraparib, AA, placebo niraparib, and placebo AA will be manufactured and provided under the
responsibility of the sponsor. Refer to the IBs for a list of excipients for niraparib and AA.24,25,26
Regular-strength niraparib/AA FDC and low-strength niraparib/AA FDC, as well as placebos for
these products, will be manufactured and provided under the responsibility of the sponsor. The
FDC drug product formulations will be manufactured as film-coated 100 mg niraparib/500 mg AA
and 50 mg niraparib/500 mg AA tablets for oral administration containing 159.40 or 79.70 mg of
niraparib tosylate monohydrate drug substance, respectively, equivalent to 100 or 50 mg niraparib
free base, and 500 mg of AA drug substance. Refer to the IB  for a list of excipients for
niraparib/AA FDC.24
For a definition of study medication overdose, refer to Section 6.7, Treatment of Overdose.
6.1.3. Special Dosing Instructions for Pharmacokinetic Visits
For PK sampling on Day 1 of Cycles 2 and 3, study medications should be taken at the site under
the supervision of the investigator or designee and should not be taken at home on the morning of
the visits; PK samples are to be obtained predose and 1-3 hours postdose. If the participant takes
the study medications prior to the visit, the PK samples should be obtained at the next cycle. On
Day 1 of Cycles 4 through 7, one PK sample is to be obtained either predose or at least 3 hours
postdose. If the study visit is in the morning, participants should refrain from taking the study
medications until after the PK sample is obtained at the investigative site. If the visit is in the
afternoon, the participant should take their study medications in the morning as usual, and the PK
sample will be collected during the study visit. If a participant’s study medication is interrupted
(eg, for toxicity), the site should contact the sponsor for instructions regarding PK sample
collection. Details of PK sampling days and times are provided in the SoA Table 3.
Additional details regarding PK sampling are provided in Section 8.4. Details of blood sample
handling and storage procedures for PK are provided in the laboratory manual.
6.2. 
Preparation/Handling/Storage/Accountability
Preparation/Handling/Storage
Niraparib could cause embryonic or fetal harm, including embryo-lethality and teratogenic effects.
Caregivers should not handle niraparib without gloves. Abiraterone acetate is contraindicated in
women who are or may potentially be pregnant. There are no human data on the use of AA in
pregnancy. Women who are pregnant or may be pregnant should not handle AA without protection
(eg, gloves). Caregivers should also not handle niraparib/AA FDC tablets without gloves.
It is not known whether niraparib or its metabolites are present in or have transient effects on the
composition of semen. It is not known whether abiraterone or its metabolites are present in semen.
Therefore, to avoid risk of drug exposure for study medications through the ejaculate (even

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
46
Status: Approved, Date: 28 August 2023
participants with vasectomies), participants must use a condom during sexual activity while on
study medication and for 3 months following the last dose of study medication. Donation of sperm
is not allowed while on study medication and for 3 months following the last dose of study
medication.
Refer to the pharmacy manual/study site investigational product and procedures manual for
additional guidance on study medication preparation, handling, and storage.
Accountability
The investigator is responsible for ensuring that all study medication received at the site is
inventoried and accounted for throughout the study. The dispensing of study medication to the
participant, and the return of study medication from the participant (if applicable), must be
documented. Participants, or their legally acceptable representatives where applicable, must be
instructed to return all original containers, whether empty or containing study medication. All
study medication will be stored and disposed of according to the sponsor's instructions. Study-site
personnel must not combine contents of the study medication containers.
Study medications must be handled in strict accordance with the protocol and the container label
and must be stored at the study site in a limited-access area or in a locked cabinet under appropriate
environmental conditions. Unused study medication, and study medication  returned by the
participant, must be available for verification by the sponsor's study site monitor during on-site
monitoring visits. The return to the sponsor of unused study medication, or used returned study
medication for destruction, will be documented. When the study site is an authorized destruction
unit and study medication supplies are destroyed on-site, this must also be documented.
Potentially hazardous materials containing hazardous liquids, should be disposed of immediately
in a safe manner and therefore will not be retained for accountability purposes.
Study medications should be dispensed under the supervision of the investigator or a qualified
member of the study-site personnel, or by a hospital/clinic pharmacist. Study medications will be
supplied only to participants participating in the study. Returned study medication must not be
dispensed again, even to the same participant. Whenever a participant brings his or her study
medications to the study site for pill count, this is not seen as a return of supplies. Study
medications may not be relabeled or reassigned for use by other participants. The investigator
agrees neither to dispense the study medication from, nor store it at, any site other than the study
sites agreed upon with the sponsor. Further guidance and information for the final disposition of
unused study medications are provided in the Investigational Product and Procedures Manual.
6.3. 
Measures to Minimize Bias: Randomization and Blinding
Study Medication Allocation
Procedures for Randomization and Stratification
Central randomization will be implemented in this study. Participants will be randomly assigned
to 1 of 2 treatment groups based on a computer-generated randomization schedule prepared by the

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
47
Status: Approved, Date: 28 August 2023
sponsor. The randomization will be balanced by using randomly permuted blocks and will be
stratified based on 3 factors: HRR gene alterations (BRCA2 alteration present versus CDK12
alteration present versus all other pathogenic alterations), prior docetaxel use (yes versus no), and
volume of disease at screening (high versus low). High-volume mCSPC is based on an adaptation
of the CHAARTED study and is defined as 1) visceral metastases or 2) at least 4 bone lesions,
with at least 1 bone lesion outside of the vertebral column or pelvis.55 Low-volume mCSPC is
defined as the presence of bone lesion(s) not meeting the definition of high-volume mCSPC.
The IWRS will assign a unique intervention code, which will dictate the intervention assignment
and matching study medication kit for the participant. The requestor must use his or her own user
identification and personal identification number when contacting the IWRS and will then give the
relevant participant details to uniquely identify the participant.
Blinding
The investigator will not be provided with randomization codes. The codes will be maintained
within the IWRS, which has the functionality to allow the investigator to break the blind for an
individual participant.
Under normal circumstances, the blind should not be broken until completion of the study or the
IDMC recommendation for unblinding is accepted by the sponsor and the database is finalized.
The investigator may, in a medical emergency, determine the identity of the study medication by
contacting the IWRS. While the responsibility to break the study medication code in emergency
situations resides solely with the investigator, it is recommended that the investigator contact the
sponsor or its designee, if possible, to discuss the particular situation, before breaking the blind.
Telephone contact with the sponsor or its designee will be available 24 hours per day, 7 days per
week. In the event the blind is broken, the sponsor must be informed as soon as possible. The date
and reason for the unblinding must be documented by the IWRS and in the source document. The
documentation received from the IWRS indicating the code break must be retained with the
participant's source documents in a secure manner. Participants who have had their treatment
assignment unblinded must discontinue study medication, have an end-of-treatment (EoT) visit,
and continue with follow-up evaluations.
6.4. 
Study Medication Compliance
A count of all study medications provided by the sponsor will be conducted during the Treatment
Phase of this study. Study medications will be dispensed, and dosing compliance will be assessed
at study visits as described in the SoA. If there are recurrent issues with dosing compliance in the
absence of toxicity, the investigator or designated study-site personnel should re-instruct
participants regarding proper dosing procedures.
The study site must maintain accurate records demonstrating dates and amount of study medication
received, to whom dispensed (participant-by-participant accounting), and accounts of any study
medication accidentally or deliberately destroyed. The amount ofstudy medication dispensed will
be recorded and compared with the amount returned. At the end of the study, reconciliation must

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
48
Status: Approved, Date: 28 August 2023
be made between the amount of study medication supplied, dispensed, and subsequently destroyed
or returned to the sponsor or its representative (see also Section 6.2).
6.5. 
Dose Modification
Any dose/dosage adjustment should be overseen by medically qualified study-site personnel
(principal or sub-investigator unless an immediate safety risk appears to be present).
All dose interruptions and dose reductions (including missed doses) and the reason for the
interruption/reduction are to be recorded in the eCRF. Note that cycle days are fixed based on the
Cycle 1 Day 1 date and will not change due to dose interruptions or delays. Management of
toxicities should be performed as detailed in Table 9.
Once the dose of study medication is reduced, any re-escalation must be discussed in advance
with the sponsor’s medical monitor.
In this section, the terms niraparib and AA refer to FDC (regular or low strength), single-agents
(niraparib and AA) or relevant placebos.
In general, dose interruptions/modifications should be managed as follows:
 All dose modifications documented in the eCRF should have an associated IWRS transaction
to ensure participants are dispensed appropriate study medications per treatment assignment.
 The dose of prednisone can remain unchanged with dose modifications of niraparib and AA.
 If niraparib is interrupted or permanently discontinued due to toxicity, then AA may be
continued. If AA is interrupted or permanently discontinued due to toxicity, then niraparib may
be continued. If AA is permanently discontinued, prednisone should also be discontinued (with
a taper if clinically indicated).
 Niraparib must be discontinued for non-hematologic treatment-related Grade ≥3 toxicities
lasting more than 28 days while the participant is administered niraparib 100 mg once daily.
General guidelines for dose modifications are provided here (Table 8), in the pharmacy manual,
and IWRS instruction manual.
Table 8: 
Guidelines for Dose Modification
General Dose Reduction Guidelines for Participants on the FDC Treatment Regimen
Dose Required  
Dose of Niraparib 
Dose of AA  
Instruction
Full dose 
200 mg 
1000 mg 
Participants will receive regular-strength FDC tablets
(active or placebo) and AA tablets (active or
placebo).
Reduced niraparib 
and full dose AA  
100 mg 
1000 mg 
Participants will receive low-strength FDC (active or
placebo) and AA tablets (active or placebo).
Full dose 
niraparib and 
reduced AA
200mg 
500 mg 
Participants will receive a single-agent combination
of niraparib (active or placebo) and AA.
Reduced both 
niraparib and AA  
100 mg 
500 mg 
Participants will receive one regular-strength FDC
tablet (active or placebo) and two AA tablets (active
or placebo).

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
51
Status: Approved, Date: 28 August 2023
Adverse Event 
Grade 
Action
Decreased platelet 
and/or neutrophil counts 
Third 
Occurrence 
Grade ≥3 
 
Interrupt niraparib and continue single-agent AA
 
Monitor levels weekly until Grade ≤1 or baseline
 
Permanently discontinue niraparib and continue single-agent AA
if neutrophils and/or platelets do not return to Grade 1 or baseline
within 28 days of dose interruption and already on 100 mg
niraparib.
Notes:
 
For participants with a platelet count ≤10,000 cells/µL, platelet transfusion per institutional standard of care
may be considered. For participants taking anti-coagulant or anti-platelet therapy, consider the risk/benefit of
interrupting these drugs or transfusion at an alternative threshold per institutional guidelines or standard of care
(eg. ≤20,000 cells/µL).
 
Weekly monitoring and/or niraparib interruption are not required if the adverse event is at baseline or lower
grade.
 
If a participant requires platelet transfusion, has neutropenic fever, or neutropenia requiring granulocyte-colony
stimulating factor for a Grade ≥3 AE deemed to be related to niraparib, interrupt niraparib and restart at reduced
dose (100 mg) after resolution to grade 1 or baseline. Continue AA at same dose. If the participant was
previously dose-reduced for the same hematologic toxicity, permanently discontinue niraparib.
 
For the management of anemia, supportive measures such as blood transfusions may be performed as deemed
necessary by the investigator per institutional standard of care.  Weekly monitoring and/or drug interruptions
for anemia are not required for screening hemoglobin values that are Grade 1 or 2. For grade ≥3 anemia,
niraparib should be interrupted until resolution to Grade <3.  Continue AA at the same dose.
 
The site should contact the medical monitor for discussion and consider discontinuation of niraparib (continue
single-agent AA) if:
o 
Hematologic toxicity has not recovered to Grade 1 or baseline after prolonged period of dose
interruption.
 
Niraparib must be discontinued in case of inadequate recovery of platelet counts and
neutrophil counts to acceptable levels (Grade 1 or baseline) within 28 days of the dose
interruption period, and if the participant has already undergone dose reduction to 100 mg.
During the study, participants who receive a diagnosis of MDS/AML, confirmed by a hematologist or oncologist,
must permanently discontinue niraparib (See Section 8.2.4).

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
53
Status: Approved, Date: 28 August 2023
medication, unless the participant has died, is lost to follow-up, has withdrawn consent or the study
is terminated by the sponsor. If the information on survival status, subsequent therapy, and disease
status progression on subsequent therapy is obtained via telephone contact, written documentation
of the communication must be available for review in the source documents. If the participant has
died, the date and cause of death will be collected and documented in the eCRF.
Investigators may recontact the participant to obtain long-term follow-up information regarding
the participant's safety or survival status including endpoint status as noted in the informed consent
form (ICF; refer to Informed Consent in Section 10.2, Appendix 2, Regulatory, Ethical, and Study
Oversight Considerations).
6.7. 
Treatment of Overdose
Overdose is addressed in the niraparib and AA IBs26,25,26and in the prednisone product information
as follows:
 Niraparib: There is no specific treatment in the event of niraparib overdose. Physicians should
follow general supportive measures, interrupt niraparib, and treat symptomatically.
 AA: In the event of an overdose, interrupt AA, undertake general supportive measures,
including monitoring for arrhythmias and cardiac failure as well as assess liver functions.
 Prednisone: Treatment of acute overdose (ie, ingestion of large quantities of prednisone over
a very short period of time) is immediate gastric lavage or emesis followed by supportive and
symptomatic therapy.
In the event of an overdose, the investigator or treating physician should:
 Closely monitor the participant for AE/SAEs and laboratory abnormalities and record in the
eCRF. In the event an AE/SAE or laboratory abnormality is observed, continue monitoring
with implementation of supportive care measures as clinically indicated until resolution or
return to baseline.
 Document the quantity of the excess dose, as well as the duration of the overdose, in the eCRF.
 Contact the Medical Monitor prior to re-starting study drug.
6.8. 
Concomitant Therapy
Prestudy and concomitant therapies must be recorded throughout the study beginning from
providing informed consent up to 30 days after the last dose of study medication.
All therapies (prescription or over-the-counter medications, including vaccines, vitamins, herbal
supplements; non-pharmacologic therapies such as electrical stimulation, acupuncture, special
diets, exercise regimens, or other specific categories of interest) different from the study
medication must be recorded in the eCRF.
6.8.1. Permitted Supportive Care and Interventions
Supportive care medications and interventions are permitted following institutional guidelines.
The following supportive care therapies are considered permissible during the study:

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
54
Status: Approved, Date: 28 August 2023
 Surgical interventions and procedures such as transurethral resection of the prostate (TURP)
and placement of ureteral stents or local radiation therapy for the management of complications
due to local progression.
 Transfusions and hematopoietic growth factors per institutional practice guidelines (Note that
blood product support and growth factor support are not allowed in the period ≤28 days prior
to randomization.).
 Prednisone dose increase by 5mg/day is permitted to manage refractory mineralocorticoid
related toxicities and should be documented in the study medication eCRF.
6.8.2. Prohibited Concomitant Therapies
The sponsor must be notified in advance (or as soon as possible thereafter) of any instances in
which the following prohibited therapies are administered. If the permissibility of a specific
drug/treatment is in question, please contact the sponsor.
 Investigational agents other than the study medications
 Other anti-cancer therapy (including, but not limited to immunotherapy and chemotherapy)
 Other systemic agents that target the androgen axis (eg, anti-androgens, CYP17 inhibitors),
except for continued GnRHa.
 Long-term use of systemically administered corticosteroids (>5 mg prednisone or the
equivalent) during the study is not allowed. Short-term use (≤4 weeks, including taper) and
locally administered steroids (eg, inhaled, topical, ophthalmic, and intra-articular) are allowed,
if clinically indicated.
 Testosterone
 Diethylstilbestrol (DES) or similar estrogen receptor agonists
 Spironolactone
 Radiopharmaceuticals such as radium-223 (223Ra), strontium (89Sr), or samarium (153Sm)
 Strong inducers of CYP3A4 (eg, rifampin)
6.8.3. Restricted Concomitant Medications
 Restrictions based on the drug interaction potential with AAP are as follows:
 Substrates of CYP2D6: caution is advised when AA is administered with medicinal products
activated by or metabolized by CYP2D6, particularly with medicinal products that have a
narrow therapeutic index. Dose reduction of medicinal products with a narrow therapeutic
index that are metabolized by CYP2D6 should be considered. Examples of medicinal products
metabolized by CYP2D6 include metoprolol, propranolol, desipramine, venlafaxine,
haloperidol, risperidone, propafenone, flecainide, codeine, oxycodone, and tramadol (the latter
3 products requiring CYP2D6 to form their active analgesic metabolites).
 Substrates of CYP2C8: In a CYP2C8 drug-drug interaction study in healthy subjects, the AUC
of pioglitazone was increased by 46% when pioglitazone was administered with a single dose
of 1000 mg AA. Although these results indicate that no clinically meaningful increases in
exposure are expected when AA is combined with drugs that are predominantly eliminated by

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
55
Status: Approved, Date: 28 August 2023
CYP2C8, participants should be monitored for signs of toxicity related to a CYP2C8 substrate
with a narrow therapeutic index (eg, paclitaxel) if used concomitantly with AA.
For the most current information regarding potential drug-drug interactions with niraparib and AA,
refer to the latest versions of the IBs for niraparib, and AA.26,25,26 Additional information is
provided in Section 10.3, Appendix 3, Additional Information on CYP450 Drug Interactions.
7. 
DISCONTINUATION OF STUDY MEDICATION AND PARTICIPANT
DISCONTINUATION/WITHDRAWAL
7.1. 
Discontinuation of Study Medication
Participants should remain on study medication until investigator-assessed radiographic
progression. Local symptoms (ie, rising PSA, need for catheter placement, pelvic radiation, etc.)
are not reasons for discontinuation of study medication. If a participant’s study medication must
be discontinued before disease progression, the participant will continue on the study and will
continue to be scanned until development of radiographic progression. If the participant has
developed radiographic progression but in the opinion of the investigator is continuing to receive
benefit from therapy, the participant may continue on study medication.
A participant's study medication must be discontinued if the investigator believes that for safety
reasons or tolerability reasons (eg, AE) it is in the best interest of the participant to discontinue
study medication (also refer to Section 6.5). Study medication may also be discontinued if the
study is terminated by the sponsor.
Study medication should be continued for participants until radiographic or clinical progression.
PSA values are not considered a reliable measure of disease progression and should not be used
as an indication to discontinue study medication.47
A participant may choose at any time to withdraw from the study medication and remain on the
study for further follow-up. All attempts should be made to collect data from the follow-up phase
such as imaging (if appropriate), survival status, electronic PROs, and any initiation of subsequent
therapies (see SoA).
7.2. 
Participant Discontinuation/Withdrawal From the Study
A participant will be withdrawn from the study for any of the following reasons:
 Lost to follow-up
 Withdrawal of participant consent for subsequent data collection
 Study is terminated by the sponsor
When a participant withdraws from the study medication and procedures before study completion,
the exact wishes of the participant with respect to what follow-up is allowed (eg, permission to
contact the participant by phone for survival status, permission to access medical records from
other providers, etc.) should be documented. When a participant withdraws all consent for any and
all further follow-up before study completion, the reason for withdrawal is to be documented in

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
56
Status: Approved, Date: 28 August 2023
the eCRF and in the source document. If the reason for withdrawal from the study is withdrawal
of consent, then no additional assessments are allowed.
If a participant is lost to follow-up, effort must be made by the study-site personnel to contact the
participant and determine endpoint status and the reason for discontinuation/withdrawal. The
measures taken to follow-up must be documented. The informed consent will stipulate that even
if a participant decides to discontinue the study medications, he will agree to be contacted
periodically by the investigator to assess endpoint status. This can be done by telephone or by chart
review. If the participant withdraws consent for all study-related procedures, then no further
contact is permitted by the investigator or the sponsor. Participant’s survival status may be
obtained by public record or cancer registry where permitted by local regulations.
Withdrawal of Consent
A participant declining to return for scheduled visits does not necessarily constitute withdrawal of
consent. Alternate follow-up mechanisms that the participant agreed to when providing informed
consent apply (eg, consult with family members, contacting the participant’s other physicians,
medical records, database searches, use of locator agencies at study completion) as local
regulations permit.
Prior to a participant withdrawing consent for follow-up, the investigator should offer the
participant an opportunity for one of the alternative reduced follow-up mechanisms described
below. Withdrawal of consent should be an infrequent occurrence in clinical studies,42 therefore,
prior to the start of the study the sponsor and the investigator should discuss and reach a clear
understanding of what constitutes withdrawal of consent in the context of the available reduced
follow-up mechanisms listed.
Circumstances for Reduced Follow-up
In the situation where a participant may be at risk for withdrawal of consent and is unable to return
for scheduled visits at the protocol-defined frequency, the investigator may consider options for
reduced follow-up. These may include (as local regulations permit):
 Less frequent clinical visits
 Telephone, email, letter, social media, fax, or other contact with:
 
participant
 
relatives of the participant
 
participant’s physicians (general or specialist)
 Review of any available medical records
Details regarding these contacts must be properly documented in source records including
responses by participants.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
57
Status: Approved, Date: 28 August 2023
7.2.1. Withdrawal From the Use of Research Samples
A participant who withdraws from the study will have the following options regarding the analysis
of research samples:
 The collected samples will be retained and used in accordance with the participant's original
separate informed consent for research samples.
 The participant may withdraw consent for analysis of research samples, in which case the
samples will be destroyed and no further testing will take place. To initiate the sample
destruction process, the investigator must notify the sponsor study site contact of withdrawal
of consent for the research samples and to request sample destruction. The sponsor study site
contact will, in turn, contact the biomarker representative to execute sample destruction. If
requested, the investigator will receive written confirmation from the sponsor that the samples
have been destroyed.
Withdrawal From the Use of Samples in Future Research
The participant may withdraw consent for use of samples for future research (refer to Section 10.2,
Long-Term Retention of Samples for Future Research). In such a case, samples will be destroyed
after they are no longer needed for the clinical study. Details of the sample retention for research
are presented in the ICF.
7.3. 
Lost to Follow-up
To reduce the chances of a participant being deemed lost to follow-up, prior to randomization
attempts should be made to obtain contact information from each participant, eg, home, work, and
mobile telephone numbers and email addresses for both the participant as well as appropriate
family members.
A participant will be considered lost to follow-up if he repeatedly fails to return for scheduled
visits and is unable to be contacted by the study site. A participant cannot be deemed lost to
follow-up until all reasonable efforts made by the study-site personnel to contact the participant
are deemed futile. The following actions must be taken if a participant fails to return to the study
site for a required study visit:
 The study-site personnel must attempt to contact the participant to reschedule the missed visit
as soon as possible, to counsel the participant on the importance of maintaining the assigned
visit schedule, to ascertain whether the participant wishes to or should continue in the study.
 Before a participant is deemed lost to follow-up, the investigator or designee must make every
reasonable effort to regain contact with the participant (where possible, 3 telephone calls,
e-mails, fax, and, if necessary, a certified letter to the participant’s last known mailing address,
or local equivalent methods. Locator agencies may also be used as local regulations permit.
These contact attempts should be documented in the participant’s medical records.
 Should the participant continue to be unreachable, they will be considered to have withdrawn
from the study.
 Should a study site close, it is expected that the investigator will work with the sponsor to
transfer the participant to another study site.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
58
Status: Approved, Date: 28 August 2023
8. 
STUDY ASSESSMENTS AND PROCEDURES
Overview
The SoA (Table 2) summarizes the frequency and timing of efficacy, biomarker, medical resource
utilization, and safety measurements applicable to this study. The SoA (Table 3) summarizes the
frequency and timing of PK assessments.
If multiple assessments are scheduled for the same timepoint, it is recommended that procedures
be performed in the following sequence: PRO questionnaires first (to prevent influencing
participant perceptions), electrocardiograms (ECGs), vital signs, and any type of blood draw last.
Blood collections for PK assessments should be kept as close to the specified time as possible.
Other measurements may be done earlier than specified timepoints if needed. Actual dates and
times of assessments will be recorded in the source documentation and eCRF. Other measurements
may be done earlier than specified timepoints if needed.
Medical resource utilization data will be collected. Refer to Section 8.7, Medical Resource
Utilization and Health Economics for details.
Qualitative Exit Interviews will be conducted with a sub-set of participants. Refer to Section 8.8,
Qualitative Exit Interview, for details.
For each participant, the maximum amount of blood drawn should not exceed 60 mL at any visit.
Refer to the laboratory manual for details regarding blood volumes to be collected for each visit.
Repeat or unscheduled samples may be taken for safety reasons or for technical issues with the
samples.
The total blood volume to be collected from each participant will be approximately 1500 mL,
depending upon what samples are taken and assuming 41 cycles of treatment and an EoT visit (see
Section 4.2.2).
Sample Collection and Handling
The actual dates and times of sample collection must be recorded in the eCRF or laboratory
requisition form.
Refer to the SoA for the timing and frequency of all sample collections.
Instructions for the collection, handling, storage, and shipment of samples are found in the
laboratory manual that will be provided. Collection, handling, storage, and shipment of samples
must be under the specified, and where applicable, controlled temperature conditions as indicated
in laboratory manual.
Study-Specific Materials
The investigator will be provided with the following supplies:
 Investigator’s brochures

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
59
Status: Approved, Date: 28 August 2023
 Pharmacy manual
 Master ICF
 Study protocol
 Laboratory manual
Additional documents will be provided as per local and study requirements.
Prescreening Phase For Biomarker Evaluation
Molecular eligibility (deleterious germline or somatic HRR gene alteration) will be established for
each potential participant before screening for other eligibility criteria (Figure 2).
Serious adverse events (SAEs) related to the study procedures will be collected from the time the
prescreening informed consent is obtained.
Screening Phase
Participants will enter the screening phase if the deleterious germline or somatic HRR gene
alteration results are positive. During screening, eligibility criteria will be reviewed, and a
complete clinical evaluation will be performed as specified in the SoA. Standard of care procedures
performed prior to informed consent will be allowed during screening and include physical exams,
vital signs, chemistry, hematology, coagulation panel (PT/INR and aPTT), PSA, ECG, CT/MRI
and bone scans.
Treatment Phase
The Treatment Phase will begin at Cycle 1 Day 1 and will continue until study medications are
discontinued. Participants must start study medication within 72 hours or 3 calendar days after
randomization. The last measurements taken on Day 1 of Cycle 1 before administration of the
study medication or at screening (whichever value was last) will be defined as the baseline values.
Visits for each cycle will have a ±3-day window through Cycle 24, and a ±14-day window for
cycles 25 through EoT, unless otherwise specified. Study visits will be calculated from the Cycle 1
Day 1 date, irrespective of any treatment interruptions. Participants may have imaging performed
within ±7 days of visits requiring images. Refer to the SoA for treatment visits and assessments
during the Treatment Phase.
Clinical evaluations and laboratory studies may be repeated more frequently, if clinically
indicated. Any on-study surgical procedures should be captured on the Surgical Procedures form
in the eCRF. Study medication will continue until disease progression, unacceptable toxicity,
death, or the sponsor terminates the study. Patients with radiographic progression can remain on
therapy if still receiving clinical benefit.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
60
Status: Approved, Date: 28 August 2023
End-of-Treatment Visit
An EoT visit must be scheduled within 30 days after the last dose of study medication or prior to
administration of a new anti-prostate cancer therapy, whichever occurs first. Refer to the SoA for
required assessments at the EoT visit. If a participant is unable to return to the site for the EoT
visit, then the participant should be contacted to collect AEs or SAEs that occurred, and
concomitant medications taken, up to 30 days after the last dose of study medications, unless the
participant has died, is lost to follow-up, or has withdrawn consent. If the information on
concomitant therapies and AEs is obtained via telephone contact, then written documentation of
the communication must be available for review in the source documents. If the participant dies,
then the date and cause of death will be collected and documented in the eCRF. Note that bone,
CT, or MRI scans performed ≤6 weeks prior to the EoT visit may serve as EoT scans. If the
participant has consented to be contacted for the Exit Interview sub-study they should be reminded
that they will be contacted by a third-party vendor Clinical Outcomes Solutions (COS) to schedule
their interview (see also Section 8.8).
Follow-up Phase
Once a participant has completed the Treatment Phase for a reason other than radiographic
progression, CT/MRI and bone scans (99mTc) should be collected every 4 months (±4 weeks) until
confirmed radiographic progression provided the participant does not withdraw consent, is lost to
follow-up, or dies. If a participant has documented radiographic progression during the Treatment
Phase, additional radiographic assessments are not required during the Follow-up Phase.
After discontinuation of all study medications, participant status will be monitored every 4 months
until participant death, lost to follow-up, withdrawal of consent, or study termination. Information
regarding survival status and initiation of subsequent prostate cancer therapies, as well as disease
progression status on the subsequent therapies, will be collected.
For the secondary and other endpoints, subsequent therapy, radiation, cancer related procedures,
symptomatic progression, and morbid events will continue to be collected as specified in the SoA.
Visits to the clinic are not required; sites may collect the information by telephone interview, chart
review, or other convenient methods. If the follow-up information is obtained via telephone
contact, then written documentation of the communication must be available for review in the
source documents.
During the Follow-up Phase, deaths regardless of causality and SAEs thought to be related to study
medications, including associated concomitant medications, will be collected and reported within
24 hours of discovery or notification of the event. Related AEs should be reported as per the
procedures in Section 10.4, Appendix 4, Adverse Events: Definitions and Procedures for
Recording, Evaluating, Follow-Up, and Reporting.
Information regarding study conduct during the Coronavirus Disease 2019 pandemic is available
in Section 10.5, Appendix 5, Guidance on Study Conduct During the COVID-19 Pandemic.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
61
Status: Approved, Date: 28 August 2023
8.1. 
Efficacy Assessments
Efficacy evaluations will be conducted as specified in the SoA. Unscheduled assessments should
be considered if clinically indicated, and results collected in the eCRF.
8.1.1. Evaluations for Primary Efficacy Assessment
The primary endpoint for this study is rPFS as assessed by the investigator, which will be evaluated
using chest, abdomen, and pelvis CT or MRI scans and whole-body bone scans (99mTc). Positron
emission tomography or positron emission tomography CT scans cannot be used in place of
technetium bone scan, conventional CT, or MRI. The same imaging modality should be used
throughout the evaluation of an individual participant, if possible. Unscheduled tumor assessment
and appropriate imaging should be considered if signs or symptoms suggestive of disease
progression, including escalating pain not attributed to another cause, worsening ECOG PS status
grade, or physical examination findings consistent with disease progression, are recorded.
Evaluation of rPFS will also be assessed by blinded independent central review (see also
Section 8.1.1.1 for definitions). All participant scans (CT/MRI and 99mTc bone scans) will be
submitted to a third-party core imaging laboratory. It is important to the integrity of the study that
all imaging studies are promptly forwarded to the core imaging laboratory throughout the study.
Blinded Independent Central Review of imaging scans may be ceased upon Sponsor decision
communicated to investigators by letter. Further details regarding materials to be forwarded for
central quality assessment can be found in the Imaging Manual or Investigator Site File.
Sites are encouraged to continue submitting scans until radiographic progression is documented
by both the investigator and blinded independent central review.
Participants without radiographic progression or death will be censored at the last disease
assessment.
8.1.1.1. 
Criteria for Primary Endpoint
Radiographic progression should be evaluated as follows:
 Progression of soft tissue lesions measured by CT or MRI as defined in RECIST 1.1.
 Progression by bone lesions observed by bone scan based on PCWG3. Under these criteria,
any bone progression must be confirmed by a subsequent scan ≥6 weeks later. The Week 8
scan (first post-treatment scan, ie, Cycle 3 Day 1) should be used as the reference to which all
subsequent scans are compared to determine progression. Bone progression is defined as one
of the following:
1. 
Participant whose Week 8 scan is observed to have ≥2 new bone lesions would fall into
one of the 2 categories below:
a) Participant whose confirmatory scan (which is performed ≥6 weeks later) shows ≥2
new lesions compared with the Week 8 scan (ie, a total of ≥4 new lesions compared
to baseline scan) will be considered to have bone scan progression at Week 8.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
62
Status: Approved, Date: 28 August 2023
b) Participant whose confirmatory scan did not show ≥2 new lesions compared with
the Week 8 scan will not be considered to have bone scan progression. The Week 8
scan will be considered as the reference scan to which subsequent scans are
compared. The FIRST scan timepoint that shows ≥2 new lesions compared with the
Week 8 scan will be considered as the bone scan progression timepoint if these new
lesions are confirmed by a subsequent scan ≥6 weeks later.
2. For a participant whose Week 8 scan does not have ≥2 new bone lesions compared with
the baseline scan, the FIRST scan timepoint that shows ≥2 new lesions compared with
the Week 8 scan will be considered as the bone scan progression timepoint if these new
lesions are confirmed by a subsequent scan ≥6 weeks later.
8.1.2. Evaluations for Other Efficacy Assessments
Other efficacy evaluations include the following:
 Survival status
 Symptomatic progression
 Subsequent systemic therapy for prostate cancer
 Cancer-related radiation therapy or surgical procedures
 Serum PSA
 PROs
 ECOG PS
8.1.2.1. 
Patient Reported Outcomes
Disease-related symptoms will be assessed using the Brief Pain Inventory-Short Form (BPI-SF)
and the prostate cancer symptom subscale of the Functional Assessment of Cancer
Therapy-Prostate (FACT-P). The single item GP5 from the FACT-P regarding “bothered by side
effects” will be described to evaluate treatment-related tolerability from the patient perspective.
Overall health-related quality of life (HRQoL) will be measured with the FACT-P and the EQ-5D-
5L to assess any impact to HRQoL from either disease-related or treatment-related experiences.
Patient-reported outcomes should be collected as per the timepoints in SoA.
All visit-specific PRO assessments should be conducted and completed before any tests,
procedures, or other consultations for that visit to prevent influencing participant perceptions.
Detailed instructions for administering the PRO questionnaires will be provided in a PRO manual.
All PRO questionnaires can be completed either at the site, via the web-based platform or over the
telephone as per the time points in the schedule of activities (SOA). In rare circumstances, such as
in case of technical issues that cannot be resolved during the visit and as a last resort where other
options for electronic completion have been explored and deemed not feasible, a paper
questionnaire should be completed by the participant, and submitted to the vendor by site staff.
Every effort should be made to have the ePRO completed by patient electronically.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
63
Status: Approved, Date: 28 August 2023
During the Follow-Up Phase, only the EQ-5D-5L will be required to be completed for 1-year post-
study medication discontinuation and this can be either at the site, via the web-based platform or
over the telephone.
Efforts will be made to minimize and manage missing data to show  a robust result
(see Section 9.4.4.1). Sites will be proactively trained on how to assist participants with PRO
collection and sufficient time will be given to complete PROs. Electronic PRO information will
also be monitored to evaluate for any trends in missing data so that investigative site staff can be
retrained, if needed.
8.1.2.1.1. 
BPI-SF
The BPI-SF is a self-administered, 11-item questionnaire, including 4 items regarding pain
intensity and 7 items on how pain has interfered with the participant’s life and activities.8,10
The recall period for the majority ofthe items is the last 24 hours. All items are rated on an 11-
point numeric rating scale (0-10), with pain intensity items scored from 0 (no pain) to 10 (pain as
bad as you can imagine) and pain interference items scored from 0 (does not interfere) to 10
(completely interferes). The BPI-SF can generally be completed in 5 minutes.
8.1.2.1.2. 
FACT-P
The FACT-P is a self-administered, 39-item questionnaire measuring HRQoL in participants with
prostate cancer.16 The recall period for all items is the past 7 days. The FACT-P includes 4
subscales that make up the FACT-General (FACT-G version 4): physical well-being, social/family
well-being, emotional well-being, and functional well-being plus a prostate cancer-specific
subscale. Responses to all items are rated on a 5-point Likert response scale ranging from 0 “not
at all” to 4 “very much”. The FACT-P can generally be completed in 8-10 minutes. Total score is
calculated with general function and prostate-cancer-specific scores and ranges from 0 to 156
(higher scores indicate better functional status).
8.1.2.1.3. 
EQ-5D-5L
The EQ-5D-5L is a self-administered, standardized measure of health status in a wide range of
health conditions and treatments.17,23,27 It provides a descriptive profile and a single index value
for health status that can be used in the clinical and economic evaluation of health care. The recall
period for all items is ‘Today’. The EQ-5D-5L consists of the EQ-5D descriptive system and the
EQ visual analogue scale (EQ-VAS). The EQ-5D descriptive system is comprised of 5 items across
the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and
anxiety/depression. The EQ-5D-5L uses a 5-point Likert response scale ranging from “No
problems” to “Extreme problems”. The EQ-5D health states defined by the EQ-5D descriptive
system can be converted into a single index value using country-specific value sets. The index
value facilitates the calculation of quality-adjusted life years that are used to inform economic
evaluations of health care interventions. The EQ-5D also includes an EQ VAS that has endpoints
labeled "best imaginable health state" and "worst imaginable health state" anchored at 100 and 0,
respectively. Participants are asked to indicate how they rate their own health by indicating the
point on the EQ VAS which best represents their own health on that day. The EQ5D-5L can
generally be completed in 2-3 minutes.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
64
Status: Approved, Date: 28 August 2023
8.1.2.1.4. 
PRO CTCAE
The NCI Patient Reported Outcomes version of the Common Terminology Criteria for Adverse
Events (PRO-CTCAE™) Measurement System was developed to evaluate symptomatic toxicities
by self-report in adults, adolescents and children participating in cancer clinical trials. It was
designed to be used as a companion to the Common Terminology Criteria for Adverse Events
(CTCAE), the standard lexicon for adverse event reporting in cancer trials. The PRO-CTCAE
assessment is being piloted to gain experience with the use of this assessment for this patient
population. Therefore, it will only be performed in the US and in English.
8.1.2.2. 
ECOG Performance Status
The ECOG PS scale (provided in Section 10.6, Appendix 6, ECOG Performance Status) will be
used to grade changes in the participant’s daily living activities. The frequency of ECOG PS
assessment is provided in the SoA (Table 2).
8.2. 
Safety Assessments
Safety assessments will be based on medical review of AE reports and the results of physical
examinations, vital sign measurements (heart rate and blood pressure), ECGs, and clinical
laboratory tests as described in the SoA (Table 2).
Details regarding the IDMC are provided in Committees Structure in Section 10.2, Appendix 2,
Regulatory, Ethical, and Study Oversight Considerations.
Adverse events will be reported and followed by the investigator as specified in Section 8.3,
Adverse Events and Serious Adverse Events and Section 10.4, Appendix 4, Adverse Events:
Definitions and Procedures for Recording, Evaluating, Follow-Up, and Reporting.
Any clinically significant abnormalities persisting at the end of the study/early withdrawal will be
followed by the investigator until resolution or until a clinically stable condition is reached.
The study will include the following evaluations of safety and tolerability according to the time
points provided in the SoA.
8.2.1. Physical Examinations
The screening physical examination will include, at a minimum, the general appearance of the
participant, height and weight, examination of the skin, ears, nose, throat, lungs, heart, abdomen,
extremities, musculoskeletal system, lymphatic system, and nervous system. During the Treatment
Phase and at the EoT visit, limited symptom-directed physical examination is required. Only
clinically relevant abnormalities found on physical examination should be reported as AEs in the
eCRF.
8.2.2. Vital Signs
As hypertension has been reported with both AA and niraparib blood pressure and heart rate will
be monitored weekly during the first 2 months (Cycles 1-2), every 2 weeks in Cycle 3, once per

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
65
Status: Approved, Date: 28 August 2023
month in Cycles 4 through 24, and then every 4 cycles thereafter through the End of Treatment.
Blood pressure collection methodology may occur as deemed reliable per investigator decision.
Pulse/heart rate and blood pressure will be assessed and recorded on the eCRF.
Pulse/heart rate and blood pressure measurements will be assessed with a completely automated
device. Manual techniques will be used only if an automated device is not available.
Blood pressure and heart rate monitoring can occur at clinic visit or may also be reported to the
site by a home nurse or other qualified medical professionals approved by the investigator and
authorized to examine patients.
8.2.3. ECGs
ECGs (12-lead) will be recorded at screening and as clinically indicated. Computer-generated
interpretations of ECGs should be reviewed for data integrity and reasonableness by the
investigator.
During the collection of ECGs, participants should be in a quiet setting without distractions (eg,
television, cell phones). Participants should rest in a supine position for at least 5 minutes before
ECG collection and should refrain from talking or moving arms or legs. If blood sampling or vital
sign measurement is scheduled for the same time point as ECG recording, the procedures should
be performed in the following order: ECG(s), vital signs, blood draw.
8.2.4. Clinical Safety Laboratory Assessments
Blood samples for serum chemistry and hematology will be collected as noted in Section 10.7,
Appendix 7, Clinical Laboratory Tests. The investigator must review the laboratory results,
document this review, and record any clinically relevant changes occurring during the study in the
adverse event section of the eCRF.
Scheduled blood samples to assess the safety of the study medications will typically be processed
by a central laboratory. Local laboratory tests may be performed as necessary. The investigator
must review laboratory results, document this review, and record any clinically relevant changes
occurring during the study in the AE section of the eCRF. For each clinically relevant laboratory
abnormality reported as an AE, the following should be reported: the value indicative of the onset
of each toxicity grade; the most abnormal value observed during the AE, and, if applicable, the
value supporting recovery to Grade 1 or to baseline values.
In the event of additional safety monitoring, unscheduled laboratory assessments may be
performed as required.
For any suspected MDS/AML case reported while a participant is receiving treatment or being
followed for post-treatment assessments, bone marrow aspirate and biopsy testing must be
completed. The study site must receive a copy of the pathology evaluation of the aspirate/biopsy
findings, and other sample testing reports related to MDS/AML. Data from the report will be

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
66
Status: Approved, Date: 28 August 2023
entered on the appropriate eCRF pages and the site must keep a copy of the report with the
participant’s study file.
Clinically laboratory tests will be performed as outlined in the SoA (Table 2) and Section 10.7,
Appendix 7, Clinical Laboratory Tests. Additional testing may be performed as clinically
indicated.
8.3. 
Adverse Events and Serious Adverse Events
Timely, accurate, and complete reporting and analysis of safety information, including adverse
events, serious adverse events, and product quality complaints (PQC) from clinical studies are
crucial for the protection of participants, investigators, and the sponsor, and are mandated by
regulatory agencies worldwide. The sponsor has established Standard Operating Procedures in
conformity with regulatory requirements worldwide to ensure appropriate reporting of safety
information; all clinical studies conducted by the sponsor or its affiliates will be conducted in
accordance with those procedures.
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate,
or the participant's legally acceptable representative) for the duration of the study.
For further details on AEs and SAEs (Definitions and Classifications; Attribution Definitions;
Severity Criteria; Special Reporting Situations; Procedures) as well as product quality complaints,
refer to Section 10.4, Appendix 4, Adverse Events: Definitions and Procedures for Recording,
Evaluating, Follow-Up, and Reporting.
8.3.1. Time Period and Frequency for Collecting Adverse Event and Serious
Adverse Event Information
All Adverse Events
All AEs and special reporting situations, whether serious or non-serious, will be reported from the
time informed consent is obtained until completion of the participant's last study-related procedure,
which may include contact for follow-up of safety. Serious adverse events, including those
spontaneously reported to the investigator within 30 days after the last dose of study medication,
must be reported using the Serious Adverse Event Form. The sponsor will evaluate any safety
information that is spontaneously reported by an investigator beyond the time frame specified in
the protocol.
Serious Adverse Events
All SAEs, as well as PQC, occurring during the study must be reported to the appropriate sponsor
contact person by study-site personnel within 24 hours of their knowledge of the event.
Information regarding SAEs must be completed and transmitted to the sponsor using the Serious
Adverse Event Form and Safety Report form of the eCRF, as well as reviewed by a physician from
the study site, within 24 hours of awareness of the SAE. The initial and follow-up reports of a SAE
should be transmitted electronically or by facsimile (fax). Telephone reporting should be the
exception and the reporter should be asked to complete the appropriate form(s) first.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
67
Status: Approved, Date: 28 August 2023
8.3.2. Method of Detecting Adverse Events and Serious Adverse Events
Care will be taken not to introduce bias when detecting AEs or SAEs. Open-ended and nonleading
verbal questioning of the participant is the preferred method to inquire about AE occurrence.
Solicited AEs
Solicited AEs are predefined local and systemic events for which the participant is specifically
questioned.
Unsolicited AEs
Unsolicited AEs are all adverse events for which the participant is not specifically questioned.
8.3.3. Follow-up of Adverse Events and Serious Adverse Events
The investigator is obligated to perform or arrange for the conduct of supplemental measurements
and evaluations as medically indicated to elucidate the nature and causality of the adverse event,
serious adverse event, or PQC as fully as possible. This may include additional laboratory tests or
investigations, histopathological examinations, or consultation with other health care
professionals.
Adverse events, including pregnancy, will be followed by the investigator as specified in
Section 10.4, Appendix 4, Adverse Events: Definitions and Procedures for Recording, Evaluating,
Follow-up, and Reporting.
8.3.4. Regulatory Reporting Requirements for Serious Adverse Events and
Anticipated Events
The sponsor assumes responsibility for appropriate reporting of the safety information to the
regulatory authorities/Independent Ethics Committee (IEC)/Institutional Review Board (IRB) in
each respective country/territory, as applicable. The sponsor will also report to the investigator
(and the head of the investigational institute where required) all suspected unexpected serious
adverse reactions (SUSARs). The investigator (or sponsor where required) must report SUSARs
to the appropriate IEC/IRB that approved the protocol unless otherwise required and documented
by the IEC/IRB. A SUSAR will be reported to regulatory authorities unblinded. Participating
investigators and IEC/IRB will receive a blinded SUSAR summary, unless otherwise specified.
An anticipated event is an AE that commonly occurs in the study population independent of
exposure to the drug under investigation.
These anticipated events will be periodically analyzed in aggregate by the sponsor during study
conduct. The sponsor will prepare a safety report in narrative format if the aggregate analysis
indicates that the anticipated event occurs more frequently in the treatment group than in the
control group and the sponsor concludes there is a reasonable possibility that the drug under
investigation caused the anticipated event.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
68
Status: Approved, Date: 28 August 2023
The plan for monitoring and analyzing the anticipated events is specified in a separate Anticipated
Events Safety Monitoring Plan. The assessment of causality will be made by the sponsor’s
unblinded safety assessment committee.
The sponsor assumes responsibility for appropriate reporting of the listed anticipated events
according to the requirements of the countries/territories in which the studies are conducted.
Anticipated events are discussed further in Section 10.8, Appendix 8, Anticipated Adverse Events.
8.3.5. Pregnancy
Niraparib has the potential to cause teratogenicity or embryo-fetal death because niraparib is
genotoxic and targets actively dividing cells in animals and patients (eg, bone marrow). In animal
studies, niraparib showed effects on sperm (reduced sperm count, spermatids, and germ cells in
epididymites and testes). Based on animal studies, niraparib may impair fertility in males of
reproductive potential. Abiraterone acetate was not noted to be genotoxic in in vitro studies;
however, abiraterone is contraindicated in women who are or may become pregnant.26
All initial reports of pregnancy in partners of male participants must be reported to the sponsor by
the study-site personnel within 24 hours of their knowledge of the event using the appropriate
pregnancy notification form. Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal
death, stillbirth, congenital anomalies, ectopic pregnancy) are considered SAEs and must be
reported using the Serious Adverse Event Form.
Follow-up information regarding the outcome of the pregnancy in a partner of a male participant
and any postnatal sequelae in the infant will be required. Pregnant partners of male participants
should also be appraised of the potential risk to the fetus.
8.3.6. Disease-Related Events and Disease-Related Outcomes Not Qualifying as
Adverse Events or Serious Adverse Events
Progression of disease should not be considered nor should be reported as an AE (or SAE).
However, signs and symptoms of disease progression or of clinical sequelae resulting from disease
progression/lack of efficacy that are determined by the investigator to be of clinical significance
should be reported per the usual reporting requirements (refer to Adverse Event Definitions and
Classifications in Section 10.4, Appendix 4, Adverse Events: Definitions and Procedures for
Recording, Evaluating, Follow-up, and Reporting). All participants must be followed for survival
until death and information relating to a participant’s death (eg, date of death and primary cause
of death) should be recorded. Fatal AEs (regardless of relationship to study medication) after
screening should be reported as SAEs for participants until 30 days after the last dose of study
medications. Death is an outcome of an AE and not an AE itself. All reports of death due to an AE
within 30 days of the last dose of study medication should include an AE term for the cause of
death (if known). Fatal events occurring after that 30-day window will not be reported as SAEs
and will be captured on the designated case report form.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
69
Status: Approved, Date: 28 August 2023
8.3.7. Adverse Events of Special Interest
Adverse events of clinical interest are:
 MDS/AML
 Grade 3 or higher anemia, thrombocytopenia, and/or neutropenia.
 Hypertension
 Hypokalemia
 Fluid retention/edema
 Hepatotoxicity
 Osteoporosis (including fracture)
 Rhabdomyolysis/myopathy
 Allergic alveolitis
 CYP2D drug interactions and food effect
 Major Adverse Cardiovascular Events (MACE).
Participants with these AEs of special interest may be counted or listed.
8.4. 
Pharmacokinetics
Blood samples will be used to evaluate the PK ofniraparib and its metabolite, M1. Blood collected
for PK may additionally be used to evaluate safety or efficacy and exploratory exposure response
analysis aspects that address concerns arising during or after the study period. Genetic analyses
will not be performed on these serum samples. Participant confidentiality will be maintained.
8.4.1. Evaluations
Venous blood samples of approximately 2 mL will be collected from all participants for
measurement of plasma concentrations of niraparib and its metabolite, M1, on Day 1 of Cycles 2
through 7, as specified in the SoA Table 3.
Samples collected for analyses of the plasma concentration for niraparib and its metabolite, M1,
may additionally be used to evaluate safety or efficacy aspects that address concerns arising during
or after the study period or for the evaluation of relevant biomarkers. Participant confidentiality
will be maintained. Additional information about the collection, handling, and shipment of
biological samples can be found in the Laboratory Manual.
8.4.2. Analytical Procedures
Pharmacokinetics
Plasma samples will be analyzed to determine concentrations of niraparib and its metabolite, M1,
using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method by
or under the supervision of the sponsor. If required, some plasma samples may be analyzed to
document the presence of circulating metabolites using a qualified research method.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
70
Status: Approved, Date: 28 August 2023
8.4.3. Pharmacokinetic Parameters and Evaluations
Parameters
Based on the individual plasma concentration-time data, using the actual dose taken and the actual
sampling times, PK parameters and exposure information of niraparib and its metabolite, M1, will
be derived using population PK modelling. Baseline covariates (eg, body weight, age, sex,
creatinine clearance, race) may be included in the model, if relevant.
Pharmacokinetic/Pharmacodynamic Evaluations
Niraparib exposure-response relationship will be explored for key efficacy (eg, rPFS, OS) and
safety parameters as data allow.
8.5. 
Genetics
A blood sample will be collected to allow for pharmacogenomic evaluations of deleterious
germline HRR gene alterations during prescreening (where local regulations permit). An on-study
blood sample will be collected (where local regulations permit) and may be used for additional
research to identify predictors of response to niraparib and AA or to allow for bridging and/or
diagnostic test development as local regulations permit.
8.6. 
Biomarkers
Sample collection and testing will comply with local regulations.
As described in Section 4.2, Scientific Rationale for Study Design, Biomarker Collection and
Section 5, Study Population, participants must have demonstrated deleterious germline or
somatic HRR gene alterations.
Stopping Analysis
Biomarker analyses are dependent upon the availability of appropriate biomarker assays and
clinical response rates. Biomarker analysis may be deferred or not performed, if during or at the
end of the study, it becomes clear that the analysis will not have sufficient scientific value for
biomarker evaluation, or if there are not enough samples or responders to allow for adequate
biomarker evaluation. In the event the study is terminated early or shows poor clinical efficacy,
completion of biomarker assessments is based on justification and intended utility of the data.
Additional Collections
If it is determined at any time before study completion that additional material is needed from a
formalin-fixed, paraffin-embedded tumor sample for the successful completion of the
protocol-specified analyses, the sponsor may request that additional material be retrieved from
existing samples. Also, based on emerging scientific evidence, the sponsor may request additional
material from previously collected tumor samples during or after study completion for a
retrospective analysis. In this case, such analyses would be specific to research related to the study
medication(s) or diseases being investigated. These additional sample collections and analyses will
only be performed as local regulations permit.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
71
Status: Approved, Date: 28 August 2023
8.6.1. 
Evaluations
Exploratory biomarkers (including DNA, RNA, or protein) will be collected where local
regulations allow. Any samples remaining after the protocol defined research analyses described
below may be used for future studies.
8.6.1.1. 
Plasma for RNA
Plasma samples will be collected as specified in the SoA. Multiple RNA transcripts found in
prostate tumors are detectable in the plasma and these samples may be used to evaluate potential
mechanisms of resistance or response that may emerge with niraparib.
8.6.1.2. 
Plasma for DNA
Plasma samples will be collected as specified in SoA and will be used to isolate circulating tumor
DNA (ctDNA) to evaluate deleterious germline or somatic HRR alterations status (where local
regulations permit) and may also be used to identify additional DNA biomarkers. In addition, the
cell pellet will be collected from Cycle 1 Day 1 to serve as a reference genome for sequencing
analysis. Plasma isolated ctDNA may be evaluated for changes in alterations observed over time,
to monitor for potential markers of resistance or response to niraparib or AA plus prednisone,
minimal residual disease or to further develop the diagnostic test to identify patients suitable for
treatment with therapeutic regimens that include niraparib. Plasma samples may also be used to
develop tests/assays related to niraparib and AA and prostate cancer.
8.6.1.3. 
Tumor Tissue Analysis
Tumor tissue (either archival or recently collected) will be obtained to evaluate deleterious
germline or somatic HRR alteration  status (when indicated) and may also be used to identify
additional DNA biomarkers associated with response to niraparib or AA plus prednisone.
Furthermore, tumor tissue may be assessed for RNA or protein signatures predictive of response.
Tumor tissue may also be used for potential bridging studies or to further develop the diagnostic
test to identify patients suitable for treatment with therapeutic regimens that include niraparib.
8.7. 
Medical Resource Utilization and Health Economics
Health Economics parameters are not evaluated in this study.
Medical resource utilization data, associated with medical encounters, will be collected in the
eCRF by the investigator and study-site personnel for all participants throughout the study.
Protocol-mandated procedures, tests, and encounters are excluded. The data collected may be used
to conduct exploratory economic analyses and will include:
 Number and duration of medical care encounters, including surgeries, and other selected
procedures (inpatient and outpatient)
 Duration of hospitalization (total days length of stay, including duration by wards, eg, intensive
care unit)
 Number and character of diagnostic and therapeutic tests and procedures

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
72
Status: Approved, Date: 28 August 2023
 Outpatient medical encounters and treatments (including physician or emergency room visits,
tests and procedures, and medications).
8.8. 
Qualitative Exit Interview
Qualitative Exit Interviews will be conducted as a sub-study in consenting participants at selected
study sites. Participants will be offered a consent for the Exit Interview and may choose to forgo
Exit Interviews without impacting any other aspect of the study.
Exit Interviews will be conducted by a third-party vendor, Clinical Outcomes Solutions (COS),
using interviewers trained in qualitative semi-structured interviewing.
Consenting participants will be entered into a Participant Tracker by study-site personnel via
secure HIPAA and General Data Protection Regulation (GDPR) compliant file sharing.  COS will
track participants’ expected EOT visit timing in order to contact the participant to schedule the
interview as close as possible after their scheduled EOT visit.
The interviews will be conducted via online video call or telephone and last approximately 60
minutes. Interviews follow a semi-structured interview guide using open-ended questions and
probes to guide discussion without leading. Interviews will explore participants’ experience of
treatment benefit, including questions about changes in symptoms or function and the meaning or
impact of perceived changes.
During the interview participants may discuss side effects that could be AEs and may or may not
have already been reported by the study site investigator. All interviewers will be trained on AE
reporting requirements and will inform the study site via secure file sharing if the participant
reports any potential AEs during the Exit Interview. In order to avoid any duplication of AE reports
the study site investigator will be responsible for handling the report as needed as per section 8.3.
There will be no further reconciliation of AEs with the Exit Interviews and interviewers will not
follow-up with participants after their interview.
 Further details on the Exit Interview process can be found in the “Study Guide for
Qualitative Interview Sub-Study to the Amplitude Clinical Trial in Prostate Cancer” and
associated Participant Interview Guide.
9. 
STATISTICAL CONSIDERATIONS
Statistical analysis will be done by the sponsor or under the authority of the sponsor. A general
description of the statistical methods to be used to analyze the efficacy and safety data is outlined
below. Specific details will be provided in the Statistical Analysis Plan (SAP).
9.1. 
Statistical Hypotheses
The hypothesis is that niraparib and AA, plus prednisone will demonstrate improved rPFS
compared with AA plus prednisone in all participants with deleterious germline or somatic HRR
gene-mutated mCSPC.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
73
Status: Approved, Date: 28 August 2023
9.2. 
Sample Size Determination
Approximately 692 participants will be randomized in a 1:1 ratio to receive niraparib and AA, plus
prednisone or AA plus prednisone. It is estimated that approximately 
 will be
required to provide 95% power in detecting a HR of 0.64
plus prednisone treatment arm versus 
treatment arm) at a 2-tailed level of significance of 0.05. With a 
month accrual period and an
additional
 months of follow-up, the study duration to reach the required number of rPFS events
will be approximately 
months.
Long term survival follow-up will continue until approximately 
 events have been
observed. 
.
The sponsor may delineate a target subpopulation of genes to be specified based on emerging
external data and may adjust accrual accordingly.
9.3. 
Populations for Analyses
For purposes of analysis, the following populations are defined:
Population 
Description
Intent-to-treat 
(ITT) 
All randomized participants classified according to their assigned treatment group, regardless
of the actual treatment received. Participant disposition and efficacy analyses will be
performed on data from the ITT population
Safety  
All randomized participants who take at least 1 dose of study medication as treated.
9.4. 
Statistical Analyses
The SAP will be finalized prior to database lock and it will include a more technical and detailed
description of the statistical analyses described in this section. This section is a summary of the
planned statistical analyses of the most important endpoints including primary and key secondary
endpoints.
All continuous variables will be summarized using number of participant (n), mean, standard
deviation (SD), median, minimum, and maximum. Discrete variables will be summarized with
number and percent. All efficacy endpoints will be analyzed using the ITT population. The Kaplan
Meier product limit method and a stratified Cox model will be used to estimate the time-to-event
variables and to obtain the HR along with the associated confidence intervals. Unless otherwise
specified, stratified log-rank tests will be used to test the treatment effect for time-to-event
variables; response rate variables will be evaluated using the chi square statistic or the exact test if
the cell counts are small.
CCI
CCI
CCI
CC
I
C
CI
C
CI
CCI
CCI

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
74
Status: Approved, Date: 28 August 2023
9.4.1. General Considerations
9.4.1.1. 
Multiplicity Adjustment for Testing of Primary and Key Secondary
Endpoints
The SAP will provide details on the graphical testing framework that will be used to strictly control
the familywise type 1 error rate at 2-sided 0.05 level.33
9.4.2. Primary Endpoint
The primary endpoint is rPFS, as assessed by the investigator, and defined as the time from the
date of randomization to the date of radiographic progression or death, whichever occurs first.
Radiographic progression is defined in Section 8.1.1.
See the SAP for further details about the analysis of the primary endpoint, including sensitivity
and subgroup analyses.
9.4.3. Secondary Endpoints
The secondary endpoints are defined as below (details in the SAP):
 OS: defined as the time from date of randomization to date of death due to any cause.
Participants alive at the time of analysis will be censored on the last date the participant was
known to be alive.
 Time to symptomatic progression: defined as time from date of randomization to the date of
any of the following (whichever occurs first):
 
The use of external beam radiation for skeletal or pelvic symptoms. Note: Only radiation
planned prior to randomization will not be considered as symptomatic progression
 
The need for tumor-related orthopedic surgical intervention
 
Other cancer-related procedures (eg, nephrostomy insertion, bladder catheter insertion,
or surgery for tumor symptoms)
 
Cancer-related morbid events (ie, fracture [symptomatic and/or pathologic], cord
compression, urinary obstructive events)
 
Initiation of a new systemic anti-cancer therapy because of cancer symptoms
 Time to subsequent therapy: defined as the time from date of randomization to the date of
initiation subsequent therapy for prostate cancer.
9.4.4. Other Endpoints
Other endpoints include the following:
 Patient-reported outcomes (see Section 9.4.4.1)
 PFS2 –Time from date of randomization to date of first occurrence of disease progression
(radiographic, clinical, or PSA progression) on first subsequent therapy for prostate cancer or
death, whichever occurs first

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
75
Status: Approved, Date: 28 August 2023
 Objective response is defined as achieving a partial response or complete response according
to modified RECIST 1.1.
 Time to PSA progression is defined as the time from the date of randomization to the date of
PSA progression based on PCWG3 criteria.49
 Objective response, rPFS, and PSA response across individual and subgroups of deleterious
germline or somatic HRR gene alterations (see Section 9.4.6).
9.4.4.1. 
Patient-reported Outcomes Analyses
Established minimum clinically important differences will be used for time-to-deterioration and
proportional analyses.6,7 The minimum clinically important differences for this study, based on the
PROs selected, are provided in Table 10.
Table 10: 
Minimum Clinically Important Differences
PRO total score or domain 
Threshold for definition of deterioration
Scores increasing reflect a worsening/deterioration
Worst Pain (BPI Question #3) 
≥30% of baseline
≥2 points
Pain Interference score (combination of BPI scale scores 
9a through 9g)
≥ half standard deviation of baseline
Average pain (Average of BPI3-6) 
≥30% of baseline
FACT-P 
Scores decreasing is worsening/deterioration
Physical Well-Being (PWB) 
≤3
Social/Family Well-Being (SFWB) 
≤3
Emotional Well-Being (EWB) 
≤3
Functional Well-Being (FWB) 
≤3
FACT-G (General) Scale 
≤9
Prostate Cancer Subscale (PCS) 
≤3
Trial Outcome Index (TOI) 
≤9
FACT-P Total Scale 
≤10
FACT-P Pain Scale 
≤2
FAPSI-8 
≤3
EQ5D HUI 
0.07 and 0.09
EQ VAS41 
7 and 10
PROs will be analyzed by accounting for change from baseline with a mixed model of repeated
measures and using a pattern mixture model as a sensitivity analysis. Fixed effects for the models
will include treatment and visit number as discrete parameters, and interaction between time and
treatment; participant is included as random effect. In addition, as a sensitivity analysis, a pattern
mixed model will be applied assuming PRO data is not missing at random.31
Time-to-deterioration and mixed model of repeated measures will be reported for BPI item 3, BPI
Pain Interference, BPI Average pain, FACT-P total and all subscale scores, and EQ-5D-5L Health
Utility Index and VAS scores. Individual items of particular interest (eg, FACT-P item GP5 “I am
bothered by side effects of treatment”) will be described by distribution of item responses. Details
of PRO analyses will be provided in the PRO-SAP.
9.4.5. Safety Analyses
All safety analyses will be made on the Safety Population.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
76
Status: Approved, Date: 28 August 2023
Adverse Events
The verbatim terms used in the eCRF by investigators to identify adverse events will be coded
using the Medical Dictionary for Regulatory Activities. Any AE occurring at or after the initial
administration of study medication through the day of last dose plus 30 days is considered to be
treatment-emergent. All reported treatment-emergent AEs will be included in the analysis. For
each AE, the percentage of participants who experience at least 1 occurrence of the given event
will be summarized by treatment group.
Summaries, listings, datasets, or participant narratives may be provided, as appropriate, for those
participants who die, who discontinue study medication due to an AE, or who experience a severe
or a serious adverse event.
Parameters with predefined NCI-CTCAE toxicity grades will be summarized. Change from
baseline to the worst adverse event grade experienced by the participant during the study will be
provided as shift tables.
Clinical Laboratory Tests
Laboratory data will be summarized by type of laboratory test. Descriptive statistics will be
calculated for each laboratory analyte at baseline and for observed values and changes from
baseline at each scheduled time point. Parameters with predefined toxicity grades will be
summarized. Change from baseline to the worst grade experienced by the participant during the
study will be provided as shift tables.
Vital Signs
Vital signs including pulse/heart rate and blood pressure (systolic and diastolic) values and changes
from baseline will be summarized over time, using descriptive statistics and/or graphically. The
percentage of participants with values beyond clinically important limits from baseline will be
summarized.
Physical Examinations
Abnormal findings in physical examination will be recorded and summarized as AEs.
9.4.6. Other Analyses
Pharmacokinetic Analyses
If feasible, population PK analysis of plasma concentration-time data of niraparib (and its M1
metabolite if needed) may be performed using nonlinear mixed-effects modeling. Data may be
combined with those of other selected studies to support a relevant structural model. Available
baseline participant characteristics (demographics, laboratory variables, genotypes, race, etc.) will
be tested as potential covariates affecting PK parameters. Details will be given in a population PK
analysis plan and the results of the population PK analysis will be presented in a separate report.
A snapshot date for PK samples to be analyzed will be defined, if required. Samples collected
before this date will be analyzed for niraparib and M1 and included in the population PK analysis.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
77
Status: Approved, Date: 28 August 2023
Samples collected after the snapshot date will be analyzed at a later date and may be included in a
population PK re-analysis when they become available after database lock.
Data will be listed for all participants with available plasma concentrations of niraparib and M1
per treatment group. Participants will be excluded from the PK analysis if their data do not allow
for accurate assessment of the PK (eg, incomplete administration of the study medication; missing
information of dosing and sampling times; concentration data not sufficient for PK parameter
calculation).
All concentrations below the lowest quantifiable concentration or missing data will be labeled as
such in the concentration database. All participants and samples excluded from the analysis will
be clearly documented in the population PK analysis report.
Descriptive statistics, including arithmetic mean, SD, coefficient of variation, median, minimum,
and maximum will be calculated for all individual derived relevant PK parameters for niraparib.
Biomarker Analyses
The association of biomarker-positivity with clinical response or time-to-event endpoints will be
assessed using appropriate statistical methods, (such as analysis of variance, categorical, or
survival models), depending on the endpoints.
Adjustments regarding the inclusion of participants with specific deleterious germline or somatic
HRR gene alterations may be made based on evidence from external data or to ensure enough
participants are enrolled to allow for subgroup analysis. Any biomarker-related enrollment
changes will be communicated to investigators.
Changes in RNA over time will be summarized by treatment group. Associations between baseline
levels and changes from baseline in select markers and clinical response (ie, rPFS and/or PSA
response) may be explored. Biomarker analyses will be summarized in separate technical reports.
DNA anomalies will be summarized by treatment group. Associations between gene level variants
and groups of variants in selected or groups of genes and clinical response (ie. rPFS, and/or PSA
response) may be explored.
Pharmacokinetic/Pharmacodynamic Analyses
The exposure-response relationship between niraparib measures of exposure (eg, derived AUC or
trough concentrations) and key efficacy (eg, rPFS and OS) and safety parameters, will be explored
graphically, as data allow. In addition, the relationship may be characterized using an exposure-
response or logistic regression model. Details will be provided in an analysis plan and detailed
results may be reported separately from the CSR.
Pharmacogenomic Analyses
DNA samples may be used for research related to niraparib and AA or prostate cancer. They may
also be used to develop tests/assays related to niraparib and AA and prostate cancer.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
78
Status: Approved, Date: 28 August 2023
Pharmacogenomic research may consist of the analysis of one or more candidate genes in relation
to niraparib and AA or prostate cancer clinical endpoints.
Results may be presented in a separate report.
Medical Resource Utilization Analyses
Medical resource utilization will be descriptively summarized by treatment group. Detailed
analyses of medical resource utilization will be reported separately from the CSR.
9.5. 
Interim Analysis for Overall Survival
Three formal interim analyses and a final analysis for OS are planned. Details are provided in the
SAP.
9.6. 
Data Monitoring Committee or Other Review Board
An IDMC will be established as noted in Committees Structure in Section 10.2, Appendix 2,
Regulatory, Ethical, and Study Oversight Considerations.
The IDMC will monitor data on an ongoing basis to ensure the continuing safety of the participants
enrolled in the study and to review efficacy information. The IDMC responsibilities, authorities,
and procedures will be documented in a separate charter.
Complete details regarding the composition and governance of the IDMC will be outlined in the
IDMC Charter.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
79
Status: Approved, Date: 28 August 2023
10. 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1. Appendix 1: Abbreviations
99mTc 
Technetium-99m
AA  
abiraterone acetate
AAP  
abiraterone acetate plus prednisone
ADT  
androgen deprivation therapy
AE  
adverse event
ALT  
alanine aminotransferase
AML 
acute myeloid leukemia
AR  
androgen receptor
AST  
aspartate aminotransferase
ATM  
ataxia telangiectasia mutated
AUC  
area under the concentration time curve
BP 
blood pressure
BPI-SF 
Brief Pain Inventory-Short Form
BRCA1 
breast cancer 1
BRCA2 
breast cancer 2
CDK12 
cyclin dependent kinase 12
CHEK2 
checkpoint kinase 2
COS  
Clinical Outcome Solutions
COVID-19 
Coronavirus Disease 2019
CT  
computed tomography
CTCAE 
Common Terminology Criteria for Adverse Events
ctDNA  
circulating tumor deoxyribonucleic acid
CTR  
Clinical Trial Regulation
CYP  
cytochrome P450
DLT  
dose-limiting toxicity
DNA  
deoxyribonucleic acid
DRD  
DNA-repair gene defect
eCRF  
electronic case report form
ECG  
electrocardiogram
ECOG PS  
Eastern Cooperative Oncology Group Performance Status
eDC  
electronic data capture
EI 
Exit Interview
EoT  
end-of-treatment
EQ-5D-5L 
Euro-Quality of Life Questionnaire
EQ VAS  
EQ-5D visual analogue scale
EU  
European Union
FACT-P 
Functional Assessment of Cancer Therapy-Prostate
FDC  
fixed-dose combination
FOIA  
Freedom of Information Act
GCP  
Good Clinical Practice
GnRHa 
gonadotropin-releasing hormone analogue
HR  
hazard ratio
HRQoL 
health-related quality of life
HRR  
homologous recombination repair
IB  
Investigator’s Brochure
IC50 
half-maximal inhibitory concentration
ICF  
informed consent form
ICH  
International Council for Harmonisation
IDMC  
Independent Data Monitoring Committee
IEC  
Independent Ethics Committee
INR  
International normalized ratio
IRB  
Institutional Review Board
ITT  
intent-to-treat
IUD  
intrauterine device

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
80
Status: Approved, Date: 28 August 2023
IUS  
intrauterine hormone releasing system
IWRS  
interactive web response system
LFT  
liver function test
LTE  
Long-term Extension
mCRPC  
metastatic castration-resistant prostate cancer
mCSPC  
metastatic castration-sensitive prostate cancer
mHSPC  
metastatic hormone-sensitive prostate cancer
MDS  
myelodysplastic syndrome
MRI 
magnetic resonance imaging
NCCN  
National Comprehensive Cancer Network
NCI-CTCAE  
National Cancer Institute Common Terminology Criteria for Adverse Events
OLE 
Open-label Extension
OS  
overall survival
PALB2 
partner and localizer of BRCA2 gene
PARP(i) 
poly (adenosine diphosphate-ribose) polymerase (inhibitor)
PCWG3 
Prostate Cancer Working Group 3
PK 
pharmacokinetic(s)
PQC  
Product Quality Complaint
PRES  
Posterior Reversible Encephalopathy Syndrome
PRO  
patient-reported outcome(s) (paper or electronic as appropriate for this study)
PRO-CTCAE  
Patient-reported Outcomes Common Terminology Criteria for Adverse Events
PSA  
prostate sensitive antigen
RECIST  
Response Evaluation Criteria in Solid Tumors
RNA  
ribonucleic acid
rPFS  
radiographic progression-free survival
SAE  
serious adverse event
SAP  
Statistical Analysis Plan
SD 
standard deviation
SoA  
Schedule of Activities
SUSAR  
suspected unexpected serious adverse reaction
ULN  
upper limit of normal
US  
United States
VCaP  
vertebral cancer of the prostate
WHO  
World Health Organization

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
81
Status: Approved, Date: 28 August 2023
10.2. Appendix 2: Regulatory, Ethical, and Study Oversight Considerations
REGULATORY AND ETHICAL CONSIDERATIONS
Investigator Responsibilities
The investigator is responsible for ensuring that the study is performed in accordance with the
protocol, current International Council for Harmonisation (ICH) guidelines on Good Clinical
Practice (GCP), and applicable regulatory and country- or territory -specific requirements.
Good Clinical Practice is an international ethical and scientific quality standard for designing,
conducting, recording, and reporting studies that involve the participation of human participants.
Compliance with this standard provides public assurance that the rights, safety, and well-being of
study participants are protected, consistent with the principles that originated in the Declaration of
Helsinki, and that the study data are credible.
Protocol Amendments
Neither the investigator nor the sponsor will modify this protocol without a formal amendment by
the sponsor. All protocol amendments must be issued by the sponsor and signed and dated by the
investigator. Protocol amendments must not be implemented without prior IEC/IRB approval, or
when the relevant competent authority has raised any grounds for non-acceptance, except when
necessary to eliminate immediate hazards to the participants, in which case the amendment must
be promptly submitted to the IEC/IRB and relevant competent authority. Documentation of
amendment approval by the investigator and IEC/IRB must be provided to the sponsor. When the
change(s) involve only logistic or administrative aspects of the study, the IEC/IRB (where
required) only needs to be notified.
During the course of the study, in situations where a departure from the protocol is unavoidable,
the investigator or other physician in attendance will contact the appropriate sponsor representative
listed in the Contact Information page(s), which will be provided as a separate document. Except
in emergency situations, this contact should be made before implementing any departure from the
protocol. In all cases, contact with the sponsor must be made as soon as possible to discuss the
situation and agree on an appropriate course of action. The data recorded in the eCRF and source
documents will reflect any departure from the protocol, and the source documents will describe
this departure and the circumstances requiring it.
Regulatory Approval/Notification
This protocol and any amendment(s) must be submitted to the appropriate regulatory authorities
in each respective country/territory, if applicable. A study may not be initiated until all local
regulatory requirements are met.
Required Prestudy Documentation
The following documents must be provided to the sponsor before shipment of study medication to
the study site:

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
82
Status: Approved, Date: 28 August 2023
 Protocol and amendment(s), if any, signed and dated by the principal investigator
 A copy of the dated and signed (or sealed, where appropriate per local regulations), written
IEC/IRB approval of the protocol, amendments, ICF, any recruiting materials, and if
applicable, participant compensation programs. This approval must clearly identify the
specific protocol by title and number and must be signed (or sealed, where appropriate per
local regulations) by the chairman or authorized designee.
 Name and address of the IEC/IRB, including a current list of the IEC/IRB members and
their function, with a statement that it is organized and operates according to GCP and the
applicable laws and regulations. If accompanied by a letter of explanation, or equivalent,
from the IEC/IRB, a general statement may be substituted for this list. If an investigator or
a member of the study-site personnel is a member of the IEC/IRB, documentation must be
obtained to state that this person did not participate in the deliberations or in the
vote/opinion of the study.
 Regulatory authority approval or notification, if applicable
 Signed and dated statement of investigator (eg, Form FDA 1572), if applicable
 Documentation of investigator qualifications (eg, curriculum vitae)
 Completed investigator financial disclosure form from the principal investigator, where
required
 Signed and dated clinical trial agreement, which includes the financial agreement
 Any other documentation required by local regulations
The following documents must be provided to the sponsor before enrollment of the first
participant:
 Completed investigator financial disclosure forms from all subinvestigators
 Documentation of subinvestigator qualifications (eg, curriculum vitae)
 Name and address of any local laboratory conducting tests for the study, and a dated copy
of current laboratory normal ranges for these tests, if applicable
 Local laboratory documentation demonstrating competence and test reliability
(eg, accreditation/license), if applicable
Independent Ethics Committee or Institutional Review Board
Before the start of the study, the investigator (or sponsor where required) will provide the IEC/IRB
with current and complete copies of the following documents (as required by local regulations):
 Final protocol and, if applicable, amendments
 Sponsor-approved ICF (and any other written materials to be provided to the participants)
 IB (or equivalent information) and amendments/addenda
 Sponsor-approved participant recruiting materials

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
83
Status: Approved, Date: 28 August 2023
 Information on compensation for study-related injuries or payment to participants for
participation in the study, if applicable
 Investigator's curriculum vitae or equivalent information (unless not required, as
documented by the IEC/IRB)
 Information regarding funding, name of the sponsor, institutional affiliations, other
potential conflicts of interest, and incentives for participants
 Any other documents that the IEC/IRB requests to fulfill its obligation
This study will be undertaken only after the IEC/IRB has given full approval of the final protocol,
amendments (if any, excluding the ones that are purely administrative, with no consequences for
participants, data or study conduct, unless required locally), the ICF, applicable recruiting
materials, and participant compensation programs, and the sponsor has received a copy of this
approval. This approval letter must be dated and must clearly identify the IEC/IRB and the
documents being approved.
Approval for the collection of samples for research and for the corresponding ICF must be obtained
from the IEC/IRB.
During the study the investigator (or sponsor where required) will send the following documents
and updates to the IEC/IRB for their review and approval, where appropriate:
 Protocol amendments (excluding the ones that are purely administrative, with no consequences
for participants, data or study conduct)
 Revision(s) to ICF and any other written materials to be provided to participants
 If applicable, new or revised participant recruiting materials approved by the sponsor
 Revisions to compensation for study-related injuries or payment to participants for
participation in the study, if applicable
 New edition(s) of the IB and amendments/addenda
 Summaries of the status of the study at intervals stipulated in guidelines of the IEC/IRB (at
least annually)
 Reports of adverse events that are serious, unlisted/unexpected, and associated with the study
medication
 New information that may adversely affect the safety of the participants or the conduct of the
study
 Deviations from or changes to the protocol to eliminate immediate hazards to the participants
 Report of deaths of participants under the investigator's care
 Notification if a new investigator is responsible for the study at the site
 Development Safety Update Report and Line Listings, where applicable
 Any other requirements of the IEC/IRB

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
84
Status: Approved, Date: 28 August 2023
For all protocol amendments (excluding the ones that are purely administrative, with no
consequences for participants, data or studyconduct), the amendment and applicable ICF revisions
must be submitted promptly to the IEC/IRB for review and approval before implementation of the
change(s).
At least once a year, the IEC/IRB will be asked to review and reapprove this study, where required.
At the end of the study, the investigator (or sponsor where required) will notify the IEC/IRB about
the study completion (if applicable, the notification will be submitted through the head of
investigational institution).
Country/Territory Selection
This study will only be conducted in those countries/territories where the intent is to launch or
otherwise help ensure access to the developed product if the need for the product persists, unless
explicitly addressed as a specific ethical consideration in Section 4.2.1, Study-Specific Ethical
Design Considerations.
Other Ethical Considerations
For study-specific ethical design considerations, refer to Section 4.2.1.
FINANCIAL DISCLOSURE
Investigators and subinvestigators will provide the sponsor with sufficient, accurate financial
information in accordance with local regulations to allow the sponsor to submit complete and
accurate financial certification or disclosure statements to the appropriate regulatory authorities.
Investigators are responsible for providing information on financial interests during the course of
the study and for 1 year after completion of the study.
INFORMED CONSENT PROCESS
Each participant must give written informed consent according to local requirements after the
nature of the study has been fully explained. The ICF must be signed before performance of any
study-related activity. The ICFs that are used must be approved by both the sponsor and by the
reviewing IEC/IRB and be in a language that the participant can read and understand. Reconsent
may be obtained remotely/virtually in accordance with sponsor procedures and where local
regulations allow. Refer to local applicable guidelines to ensure compliance. The informed consent
should be in accordance with principles that originated in the Declaration of Helsinki, current ICH
and GCP guidelines, applicable regulatory requirements, and sponsor policy.
Before enrollment in the study, the investigator or an authorized member of the study-site
personnel must explain to potential participants the aims, methods, reasonably anticipated benefits,
and potential hazards of the study, and any discomfort participation in the study may entail.
Participants will be informed that their participation is voluntary and that they may withdraw
consent to participate at any time. They will be informed that choosing not to participate will not
affect the care the participant will receive for the treatment of his disease. Participants will be told
that alternative treatments are available if they refuse to take part and that such refusal will not

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
85
Status: Approved, Date: 28 August 2023
prejudice future treatment. Finally, they will be told that the investigator will maintain a participant
identification register for the purposes of long-term follow-up if needed and that their records may
be accessed by health authorities and authorized sponsor personnel without violating the
confidentiality of the participant, to the extent permitted by the applicable law(s) or regulations.
By signing the ICF, the participant is authorizing such access, which includes permission to obtain
information about his or her survival status. It also denotes that the participant agrees to allow his
or her study physician to recontact the participant for the purpose of obtaining consent for
additional safety evaluations, and subsequent disease-related treatments, if needed. The physician
may also recontact the participant for the purpose of obtaining consent to collect information about
his or her survival status.
The participant will be given sufficient time to read the ICF and the opportunity to ask questions.
After this explanation and before entry into the study, a written consent should be appropriately
recorded by means of the participant’s personally dated signature. After having obtained the
consent, a copy of the ICF must be given to the participant.
Participants who are rescreened are required to provide new consent.
Participants will be asked for consent to provide samples for research (where local regulations
permit). After informed consent for the study is appropriately obtained, the participant may be
asked to provide separate informed consent to participate in the research component. A copy of
the completed ICF will be given to the participant.
Where local regulations require, a separate ICF may be used for the required DNA component of
the study.
RECRUITMENT STRATEGY
The first site open is considered the first act of recruitment and it becomes the study start date.
The Sponsor has provided the study sites with optional patient recruitment material templates, to
be used in accordance with local regulations and policies.
DATA PROTECTION
Privacy of Personal Data
The collection and processing of personal data from participants enrolled in this study will be
limited to those data that are necessary to fulfill the objectives of the study.
These data must be collected and processed with adequate precautions to ensure confidentiality
and compliance with applicable data privacy protection laws and regulations. Appropriate
technical and organizational measures to protect the personal data against unauthorized disclosures
or access, accidental or unlawful destruction, or accidental loss or alteration must be put in place.
Sponsor personnel whose responsibilities require access to personal data agree to keep the identity
of participants confidential.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
86
Status: Approved, Date: 28 August 2023
The informed consent obtained from the participant includes explicit consent for the processing of
personal data and for the investigator/institution to allow direct access to his or her original medical
records (source data/documents) for study-related monitoring, audit, IEC/IRB review, and
regulatory inspection. This consent also addresses the transfer of the data to other entities and to
other countries/territories.
The participant has the right to request through the investigator access to his or her personal data
and the right to request rectification of any data that are not correct or complete. Reasonable steps
will be taken to respond to such a request, taking into consideration the nature of the request, the
conditions of the study, and the applicable laws and regulations.
In the event of a data security breach, the sponsor will apply measures to adequately manage and
mitigate possible adverse effects taking into consideration the nature of the data security breach as
necessary to address other obligations such as notifying appropriate authorities in accordance with
applicable data protection law.
Exploratory DNA, pharmacogenomics, biomarker, and PK research is not conducted under
standards appropriate for the return of data to participants. In addition, the sponsor cannot make
decisions as to the significance of any findings resulting from exploratory research. Therefore,
exploratory research data will not be returned to participants or investigators, unless required by
law or local regulations. Privacy and confidentiality of data generated in the future on stored
samples will be protected by the same standards applicable to all other clinical data.
LONG-TERM RETENTION OF SAMPLES FOR FUTURE RESEARCH
Samples collected in this study may be stored for up to 15 years (or according to local regulations)
for future research. Samples will only be used to understand niraparib and AA, to understand
prostate cancer in patients with deleterious germline or somatic HRR gene mutations, to
understand differential study medication responders, and to develop tests/assays related to
niraparib and AA and prostate cancer in patients with deleterious germline or somatic HRR gene
mutations or other genes related to niraparib or AA. The research may begin at any time during
the study or the post-study storage period.
Stored samples will be coded throughout the sample storage and analysis process and will not be
labeled with personal identifiers. Participants may withdraw their consent for their samples to be
stored for research (refer to Section 7.2.1, Withdrawal From the Use of Research Samples).
COMMITTEES STRUCTURE
Independent Data Monitoring Committee
A IDMC will be established to monitor data on an ongoing basis to review interim data, to ensure
the continuing safety of the participants enrolled in this study, and to meet efficacy objectives.
This committee will consist of at least one medical expert in the relevant therapeutic area and at
least one statistician; committee membership responsibilities, authorities, and procedures will be
documented in its charter.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
87
Status: Approved, Date: 28 August 2023
PUBLICATION POLICY/DISSEMINATION OF CLINICAL STUDY DATA
All information, including but not limited to information regarding niraparib/AA FDC or the
sponsor's operations (eg, patent application, formulas, manufacturing processes, basic scientific
data, prior clinical data, formulation information) supplied by the sponsor to the investigator and
not previously published, and any data, including pharmacogenomic or exploratory biomarker
research data, generated as a result of this study, are considered confidential and remain the sole
property of the sponsor. The investigator agrees to maintain this information in confidence and use
this information only to accomplish this study and will not use it for other purposes without the
sponsor's prior consent.
The investigator understands that the information developed in the study will be used by the
sponsor in connection with the continued development of niraparib and AA and thus may be
disclosed as required to other clinical investigators or regulatory agencies. To permit the
information derived from the clinical studies to be used, the investigator is obligated to provide
the sponsor with all data obtained in the study.
The results of the study will be reported in a Clinical Study Report generated by the sponsor and
will contain data from all study sites that participated in the study as per protocol. Recruitment
performance or specific expertise related to the nature and the key assessment parameters of the
study will be used to determine a coordinating investigator for the study. Results of
pharmacogenomic and exploratory biomarker analyses performed after the Clinical Study Report
has been issued will be reported in a separate report and will not require a revision of the Clinical
Study Report.
Study participant identifiers will not be used in publication of results. Any work created in
connection with performance of the study and contained in the data that can benefit from copyright
protection (except any publication by the investigator as provided for below) shall be the property
of the sponsor as author and owner of copyright in such work.
Consistent with Good Publication Practices and International Committee of Medical Journal
Editors (ICMJE) guidelines, the sponsor shall have the right to publish such primary (multicenter)
data and information without approval from the investigator. The investigator has the right to
publish study site-specific data after the primary data are published. If an investigator wishes to
publish information from the study, a copy of the manuscript must be provided to the sponsor for
review at least 60 days before submission for publication or presentation. Expedited reviews will
be arranged for abstracts, poster presentations, or other materials. If requested by the sponsor in
writing, the investigator will withhold such publication for up to an additional 60 days to allow for
filing of a patent application. In the event that issues arise regarding scientific integrity or
regulatory compliance, the sponsor will review these issues with the investigator. The sponsor will
not mandate modifications to scientific content and does not have the right to suppress information.
For multicenter study designs and sub-study approaches, secondary results generally should not
be published before the primary endpoints of a study have been published. Similarly, investigators
will recognize the integrity of a multicenter study by not submitting for publication data derived
from the individual study site until the combined results from the completed study have been

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
88
Status: Approved, Date: 28 August 2023
submitted for publication, within 18 months after the study end date, or the sponsor confirms there
will be no multicenter study publication. Authorship of publications resulting from this study will
be based on the guidelines on authorship, such as those described in the ICMJE Recommendations
for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals, which
state that the named authors must have made a significant contribution to the conception or design
of the work; or the acquisition, analysis, or interpretation of the data for the work; and drafted the
work or revised it critically for important intellectual content; and given final approval of the
version to be published; and agreed to be accountable for all aspects of the work in ensuring that
questions related to the accuracy or integrity of any part of the work are appropriately investigated
and resolved.
Registration of Clinical Studies and Disclosure of Results
The sponsor will register and disclose the existence of and the results of clinical studies as required
by law. The disclosure of the final study results will be performed after the end of study in order
to ensure the statistical analyses are relevant.
DATA QUALITY ASSURANCE
Data Quality Assurance/Quality Control
Steps to be taken to ensure the accuracy and reliability of data include the selection of qualified
investigators and appropriate study sites, review of protocol procedures with the investigator and
study-site personnel before the study, periodic monitoring visits by the sponsor, and direct
transmission of clinical laboratory data from a central laboratory into the sponsor's database.
Written instructions will be provided for collection, handling, storage, and shipment of samples.
Guidelines for eCRF completion will be provided and reviewed with study-site personnel before
the start of the study. The sponsor will review eCRF for accuracy and completeness during on-site
monitoring visits and after transmission to the sponsor; any discrepancies will be resolved with the
investigator or designee, as appropriate. After upload of the data into the study database they will
be verified for accuracy and consistency with the data sources.
CASE REPORT FORM COMPLETION
Case report forms are prepared and provided by the sponsor for each participant in electronic
format. All data relating to the study must be recorded in eCRF. All eCRF entries, corrections, and
alterations must be made by the investigator or authorized study-site personnel. The investigator
must verify that all data entries in the eCRF are accurate and correct.
The study data will be transcribed by study-site personnel from the source documents onto an
eCRF, if applicable. Study-specific data will be transmitted in a secure manner to the sponsor.
Worksheets may be used for the capture of some data to facilitate completion of the eCRF. Any
such worksheets will become part of the participant's source documents. Data must be entered into
eCRF in English. The eCRF must be completed as soon as possible after a participant visit and the
forms should be available for review at the next scheduled monitoring visit.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
89
Status: Approved, Date: 28 August 2023
All participative measurements (eg, pain scale information or other questionnaires) will be
completed by the same individual who made the initial baseline determinations whenever possible.
If necessary, queries will be generated in the electronic Data Capture (eDC) tool. If corrections to
a eCRF are needed after the initial entry into the eCRF, this can be done in either of the following
ways:
 Investigator and study-site personnel can make corrections in the eDC tool at their own
initiative or as a response to an auto query (generated by the eDC tool).
 Sponsor or sponsor delegate can generate a query for resolution by the investigator and study-
site personnel.
SOURCE DOCUMENTS
At a minimum, source documents consistent in the type and level of detail with that commonly
recorded at the study site as a basis for standard medical care must be available for the following:
participant identification, eligibility, and study identification; study discussion and date informed
consent was obtained; dates of visits; results of safety and efficacy parameters as required by the
protocol; record of all adverse events and follow-up of adverse events; concomitant medication;
study medication receipt/dispensing/return records; study medication administration information;
and date of study completion and reason for early discontinuation of study medication or
withdrawal from the study, if applicable.
The author of an entry in the source documents should be identifiable.
Specific details required as source data for the study and source data collection methods will be
reviewed with the investigator before the study and will be described in the monitoring guidelines
(or other equivalent document).
The minimum source documentation requirements for Section 5.1, Inclusion Criteria and
Section 5.2, Exclusion Criteria that specify a need for documented medical history are as follows:
 Referral letter from treating physician or
 Complete history of medical notes at the site
 Discharge summaries
Inclusion and exclusion criteria not requiring documented medical history must be verified at a
minimum by participant interview or other protocol required assessment (eg, physical
examination, laboratory assessment) and documented in the source documents.
An eSource system may be utilized, which contains data traditionally maintained in a hospital or
clinic record to document medical care (eg, electronic source documents) as well as the clinical
study-specific data fields as determined by the protocol. This data is electronically extracted for
use by the sponsor. If eSource is utilized, references made to the eCRF in the protocol include the
eSource system but information collected through eSource may not be limited to that found in the
eCRF.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
90
Status: Approved, Date: 28 August 2023
MONITORING
The sponsor will perform on-site monitoring visits as frequently as necessary. The monitor will
record dates of the visits in a study site visit log that will be kept at the study site. The first post-
initiation visit will be made as soon as possible after enrollment has begun. At these visits, the
monitor will compare the data entered into the eCRF with the source documents
(eg, hospital/clinic/physician’s office medical records). The nature and location of all source
documents will be identified to ensure that all sources of original data required to complete the
eCRF are known to the sponsor and study-site personnel and are accessible for verification by the
sponsor study-site contact. If electronic records are maintained at the study site, the method of
verification must be discussed with the study-site personnel.
Direct access to source documents (medical records) must be allowed for the purpose of verifying
that the recorded data are consistent with the original source data. Findings from this review will
be discussed with the study-site personnel. The sponsor expects that, during monitoring visits, the
relevant study-site personnel will be available, the source documents will be accessible, and a
suitable environment will be provided for review of study-related documents. The monitor will
meet with the investigator on a regular basis during the study to provide feedback on the study
conduct.
In addition to on-site monitoring visits, remote contacts can occur. It is expected that during these
remote contacts, study-site personnel will be available to provide an update on the progress of the
study at the site.
ON-SITE AUDITS
Representatives of the sponsor's clinical quality assurance department may visit the study site at
any time during or after completion of the study to conduct an audit of the study in compliance
with regulatory guidelines and company policy. These audits will require access to all study
records, including source documents, for inspection. Participant privacy must, however, be
respected. The investigator and study-site personnel are responsible for being present and available
for consultation during routinely scheduled study-site audit visits conducted by the sponsor or its
designees.
Similar auditing procedures may also be conducted by agents of any regulatory body, either as part
of a national GCP compliance program or to review the results of this study in support of a
regulatory submission. The investigator should immediately notify the sponsor if he or she has
been contacted by a regulatory agency concerning an upcoming inspection.
RECORD RETENTION
In compliance with the ICH/GCP guidelines, the investigator/institution will maintain all eCRF
and all source documents that support the data collected from each participant, as well as all study
documents as specified in ICH/GCP Section 8, Essential Documents for the Conduct of a Clinical
Trial, and all study documents as specified by the applicable regulatory requirement(s). The
investigator/institution will take measures to prevent accidental or premature destruction of these
documents.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
91
Status: Approved, Date: 28 August 2023
Essential documents must be retained until at least 2 years after the last approval of a marketing
application in an ICH region and until there are no pending or contemplated marketing applications
in an ICH region or until at least 2 years have elapsed since the formal discontinuation of clinical
development of the investigational product. These documents will be retained for a longer period
if required by the applicable regulatory requirements or by an agreement with the sponsor. It is the
responsibility of the sponsor to inform the investigator/institution as to when these documents no
longer need to be retained.
If the responsible investigator retires, relocates, or for other reasons withdraws from the
responsibility of keeping the study records, custody must be transferred to a person who will accept
the responsibility. The sponsor must be notified in writing of the name and address of the new
custodian. Under no circumstance shall the investigator relocate or dispose of any study documents
before having obtained written approval from the sponsor.
If it becomes necessary for the sponsor or the appropriate regulatory authority to review any
documentation relating to this study, the investigator/institution must permit access to such reports.
STUDY AND SITE START AND CLOSURE
First Act of Recruitment
The first site open is considered the first act of recruitment and it becomes the study start date.
Study Termination
The sponsor reserves the right to close the study site or terminate the study at any time for any
reason at the sole discretion of the sponsor. Study sites will be closed upon study completion. A
study site is considered closed when all required documents and study supplies have been collected
and a study-site closure visit has been performed.
The investigator may initiate study-site closure at any time, provided there is reasonable cause and
sufficient notice is given in advance of the intended termination.
Reasons for the early closure of a study site by the sponsor or investigator may include but are not
limited to:
 Failure of the investigator to comply with the protocol, the requirements of the IEC/IRB or
local health authorities, the sponsor's procedures, or GCP guidelines
 Inadequate recruitment of participants by the investigator
 Discontinuation of further study medication development

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
92
Status: Approved, Date: 28 August 2023
10.3. Appendix 3: Additional Information on CYP450 Drug Interactions
http://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/druginteractionslabeling/u
cm093664.htm.19
http://medicine.iupui.edu/clinpharm/ddis/table.aspx

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
93
Status: Approved, Date: 28 August 2023
10.4. Appendix 4: Adverse Events, Serious Adverse Events, Product Quality
Complaints, and Other Safety Reporting: Definitions and Procedures for
Recording, Evaluating, Follow-up, and Reporting
ADVERSE EVENT DEFINITIONS AND CLASSIFICATIONS
Adverse Event
An adverse event is any untoward medical occurrence in a clinical study participant administered
a pharmaceutical (investigational or non-investigational) product. An adverse event does not
necessarily have a causal relationship with the study medication. An adverse event can therefore
be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease
temporally associated with the use of a medicinal (investigational or non-investigational) product,
whether or not related to that medicinal (investigational or non-investigational) product.
(Definition per ICH).
This includes any occurrence that is new in onset or aggravated in severity or frequency from the
baseline condition, or abnormal results of diagnostic procedures, including laboratory test
abnormalities.
Note: The sponsor collects adverse events starting with obtaining informed consent (refer to All
Adverse Events under Section 8.3.1, Time Period and Frequency for Collecting Adverse Events
and Serious Adverse Events Information, for time of last adverse event recording).
Serious Adverse Event
A serious adverse event based on ICH and EU Guidelines on Pharmacovigilance for Medicinal
Products for Human Use is any untoward medical occurrence that at any dose:
 Results in death
 Is life-threatening
(The participant was at risk of death at the time of the event. It does not refer to an event that
hypothetically might have caused death if it were more severe.)
 Requires inpatient hospitalization or prolongation of existing hospitalization
 Results in persistent or significant disability/incapacity
 Is a congenital anomaly/birth defect
 Is a suspected transmission of any infectious agent via a medicinal product
 Is Medically Important*
*Medical and scientific judgment should be exercised in deciding whether expedited reporting is
also appropriate in other situations, such as important medical events that may not be immediately
life threatening or result in death or hospitalization but may jeopardize the participant or may
require intervention to prevent one of the other outcomes listed in the definition above. These
should usually be considered serious.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
94
Status: Approved, Date: 28 August 2023
Unlisted (Unexpected) Adverse Event/Reference Safety Information
An adverse event is considered unlisted if the nature or severity is not consistent with the applicable
product reference safety information. For niraparib/AA FDC, the expectedness of an adverse event
will be determined by whether or not it is listed in the niraparib, AA or FDC IBs. For single agent
niraparib, the expectedness of an adverse event will be determined by whether or not it is listed in
the IB. For single agent AA, the expectedness of an adverse event will be determined by whether
or not it is listed in the IB.
ATTRIBUTION DEFINITIONS
Assessment of Causality
The causal relationship to study medication is determined by the Investigator. The following
selection should be used to assess all adverse events (AE).
Related
There is a reasonable causal relationship between study medication administration and the AE.
Not Related
There is not a reasonable causal relationship between study medication administration and the AE.
The term "reasonable causal relationship" means there is evidence to support a causal relationship.
SEVERITY CRITERIA
An assessment of severity grade will be made using the NCI-CTCAE (Version 5.0). Any AE not
listed in the NCI-CTCAE will be graded according to the investigator’s clinical judgment using
the standard grades as follows:
Grade 1 (Mild): Awareness of symptoms that are easily tolerated, causing minimal discomfort
and not interfering with everyday activities.
Grade 2 (Moderate): Sufficient discomfort is present to cause interference with normal activity.
Grade 3 (Severe): Extreme distress, causing significant impairment of functioning or
incapacitation. Prevents normal everyday activities.
Grade 4, Life-threatening: Urgent intervention indicated.
Grade 5, Death: Death.
The investigator should use clinical judgment in assessing the severity of events not directly
experienced by the participant (eg, laboratory abnormalities).
SPECIAL REPORTING SITUATIONS
Safety events of interest on a sponsor study medication in an interventional study that may require
expedited reporting or safety evaluation include, but are not limited to:

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
95
Status: Approved, Date: 28 August 2023
 Overdose of a sponsor study medication
 Suspected abuse/misuse of a sponsor study medication
 Accidental or occupational exposure to a sponsor study medication
 Medication error, intercepted medication error, or potential medication error involving a
Johnson & Johnson medicinal product (with or without patient exposure to the Johnson &
Johnson medicinal product, eg, product name confusion, product label confusion, intercepted
prescribing or dispensing errors)
Special reporting situations should be recorded in the eCRF. Any special reporting situation that
meets the criteria of a serious adverse event should be recorded on the serious adverse event page
of the eCRF.
PROCEDURES
All Adverse Events
All adverse events, regardless of seriousness, severity, or presumed relationship to study
medication, must be recorded using medical terminology in the source document and the eCRF.
Whenever possible, diagnoses should be given when signs and symptoms are due to a common
etiology (eg, cough, runny nose, sneezing, sore throat, and head congestion should be reported as
"upper respiratory infection"). Investigators must record in the eCRF their opinion concerning the
relationship of the adverse event to study therapy. All measures required for adverse event
management must be recorded in the source document and reported according to sponsor
instructions.
For all studies with an outpatient phase, including open-label studies, the participant must be
provided with a "wallet (study) card" and instructed to carry this card with them for the duration
of the study indicating the following:
 Study number
 Statement, in the local language(s), that the participant is participating in a clinical study
 Investigator's name and 24-hour contact telephone number
 Local sponsor's name and 24-hour contact telephone number (for medical personnel only)
 Site number
 Participant number
 Any other information that is required to do an emergency breaking of the blind
Serious Adverse Events
All serious adverse events that have not resolved by the end of the study, or that have not resolved
upon discontinuation of the participant's participation in the study, must be followed until any of
the following occurs:
 The event resolves

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
96
Status: Approved, Date: 28 August 2023
 The event stabilizes
 The event returns to baseline, if a baseline value/status is available
 The event can be attributed to agents other than the study medication or to factors unrelated to
study conduct
 It becomes unlikely that any additional information can be obtained (participant or health care
practitioner refusal to provide additional information, lost to follow-up after demonstration of
due diligence with follow-up efforts)
Suspected transmission of an infectious agent by a medicinal product will be reported as a serious
adverse event. Any event requiring hospitalization (or prolongation of hospitalization) that occurs
during the course of a participant's participation in a study must be reported as a serious adverse
event, except hospitalizations for the following:
 Hospitalizations not intended to treat an acute illness or adverse event (eg, social reasons such
as pending placement in long-term care facility)
 Surgery or procedure planned before entry into the study (must be documented in the eCRF).
Expected progression of disease should not be considered an adverse event (or serious adverse
event). However, if determined by the investigator to be more likely related to the study medication
than the underlying disease, the clinical signs or symptoms of progression and the possibility that
the study medication is enhancing disease progression, should be reported per the usual reporting
requirements.
During the Follow-up Phase of the study, deaths regardless of causality will be reported in the
eCRF. Serious AEs, including those spontaneously reported to the investigator within 30 days after
the last dose of study medication, must be reported using the Serious Adverse Event Form. Serious
AEs that occur after 30 days following the last study medication administration thought to be
related to study medication will be collected and reported via the Serious Adverse Event Form
within 24 hours of discovery or notification of the event and documented.
CONTACTING SPONSOR REGARDING SAFETY
The names (and corresponding telephone numbers) of the individuals who should be contacted
regarding safety issues or questions regarding the study are listed in the Contact Information
page(s), which will be provided as a separate document.
PRODUCT QUALITY COMPLAINT HANDLING
A product quality complaint (PQC) is defined as any suspicion of a product defect related to
manufacturing, labeling, or packaging, ie, any dissatisfaction relative to the identity, quality,
durability, reliability, or performance of a distributed product, including its labeling, drug delivery
system, or package integrity. A PQC may have an impact on the safety and efficacy of the product..
In addition, it includes any technical complaints, defined as any complaint that indicates a potential
quality issue during manufacturing, packaging, release testing, stability monitoring, dose
preparation, storage or distribution of the product or the drug delivery system.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
97
Status: Approved, Date: 28 August 2023
Procedures
All initial PQCs must be reported to the sponsor by the study-site personnel within 24 hours after
being made aware of the event.
A sample of the suspected product should be maintained under the correct storage conditions until
a shipment request is received from the sponsor.
Contacting Sponsor Regarding Safety, Including Product Quality
The names (and corresponding telephone numbers) of the individuals who should be contacted
regarding safety issues, PQC, or questions regarding the study are listed in the Contact Information
page(s), which will be provided as a separate document.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
98
Status: Approved, Date: 28 August 2023
10.5. Appendix 5: Guidance on Study Conduct During the COVID-19 Pandemic
It is recognized that the Coronavirus Disease 2019 (COVID-19) pandemic may have an impact on
the conduct of this clinical study due to, for example, self-isolation/quarantine by participants and
study-site personnel; travel restrictions/limited access to public places, including hospitals; and
study site personnel being reassigned to critical clinical tasks.
In alignment with recent health authority guidance, the sponsor is providing options for
study-related participant management in the event of disruption to the conduct of the study. This
guidance does not supersede any local or government requirements or the clinical judgement of
the investigator to protect the health and well-being of participants and site staff. If at any time a
participant’s safety is considered to be at risk, study medication will be discontinued, and study
follow-up will be conducted.
Scheduled visits that cannot be conducted in person at the study site may be performed to the
extent possible remotely/virtually or delayed until such time that on-site visits can be resumed. At
each contact, participants should be interviewed to collect safety data. Key efficacy endpoint
assessments should be performed if required and as feasible. Participants will also be questioned
regarding general health status to fulfill any physical examination requirement.
Every effort should be made to adhere to protocol-specified assessments for participants on study
medication, including follow-up. Modifications to protocol-required assessments may be
permitted via COVID-19 Appendix after consultation with the participant, investigator, and the
sponsor. Examples of modifications are presented under the GUIDANCE SPECIFIC TO THIS
PROTOCOL. Missed assessments/visits will be captured in the clinical trial management system
for protocol deviations. Discontinuations of study medications and withdrawal from the study
should be documented with the prefix “COVID-19-related” in the CRF.
The sponsor will continue to monitor the conduct and progress of the clinical study, and any
changes will be communicated to the sites and to the health authorities according to local guidance.
If a participant has tested positive for COVID-19, the investigator should contact the sponsor’s
responsible medical officer to discuss plans for study medication and follow-up. Modifications
made to the study conduct as a result of the COVID-19 pandemic should be summarized in the
clinical study report.
GUIDANCE SPECIFIC TO THIS PROTOCOL
These provisions are meant to minimize the risk of exposure to COVID-19 and to safely maintain
participants on study medication while site capabilities are compromised by COVID-19-related
restrictions. As restrictions are lifted and the acute phase of the COVID-19 pandemic resolves,
sites should revert to original protocol conduct as soon as feasible.
Study Visits - General
 To protect study participants from being unnecessarily exposed to COVID-19, at sites that
have been affected, those participants who are doing well and for whom there is no safety
concern may have home health or tele-health visits (conducted via phone or computer). Normal

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
99
Status: Approved, Date: 28 August 2023
study procedures (eg, Eastern Cooperative Oncology Group assessment, adverse event
reporting) should be followed for the applicable visit as possible. Regular blood pressure
monitoring can be performed at home, if possible. Other programs may be implemented by or
with approval from the sponsor, such as home health care visits for study assessments and
procedures (eg, physical examination, lab draws, etc), where feasible and permissible by local
policy and regulations.
 The benefit of continuing treatment should be balanced with the risks of treatment without the
usual clinical supervision. For participants who have recently had adverse events that required
a study medication interruption or dose reduction, or for those participants who are at increased
risk for severe COVID-19 infection based on age or comorbidities, a temporary interruption of
study medication should be considered by the investigator and documented in the source and
electronic CRF (eCRF).
Prescreening, Screening and Randomization
 Prescreening, screening, and randomization to the study may continue during the COVID-19
pandemic if the benefits of study medication outweigh the risks, as per the investigator’s
assessment. If it is anticipated that the situation may worsen at the site and that health care
capacities may become more limited, then screening and randomization should be delayed for
participant safety. When randomization occurs at the site, the screening procedures may be
utilized after discussion with the sponsor, despite being out of window.
Study Visits –Assessments
 If possible, central safety laboratory testing is to be continued. However, if central laboratory
tests cannot be performed, the use of a local laboratory is allowed for study evaluations. A
copy of the local laboratory report should be reviewed by the investigator and retained, along
with the reference ranges, for the source documentation and documented in the eCRF. If
research-specific blood collection is not possible (eg, biomarker, pharmacokinetic collection)
then the missed sample should be documented as a deviation.
 If visits are conducted remotely, then electronic patient-reported outcomes information should
be collected via phone using interview mode on the site tablet or web-based platform available
to participants.
 If safe to do so, then participants should come to their usual site for imaging visits. If imaging
cannot be performed at the site due to travel restrictions, the use of a local facility close to the
participant’s home is permitted, but provision of scans to the investigative site should be
arranged and documented. If no imaging is possible, the missed visit should be documented as
a deviation, and imaging should be resumed when possible.
Study Medication Supply
 For participants able to visit the clinic/hospital, but who request to reduce visit frequency, an
additional supply of study medications can be provided.
 For participants unable to visit the clinic/hospital, direct-to-patient (DTP) shipment of study
medications may be implemented, where allowed per local regulations and if requested by the
treating study physician. Where DTP shipments are deemed necessary, the process should be

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
100
Status: Approved, Date: 28 August 2023
coordinated between the site and sponsor staff following standard DTP procedures for
arranging shipment and adhering to associated approvals and documentation requirements.
Exposure to COVID-19
 If a participant develops COVID-19 infection, niraparib and AA, plus prednisone or AA plus
prednisone should be interrupted until the infection resolves.
 Resumption of treatment: When a participant recovers from suspected or confirmed
COVID-19 infection, niraparib and AA, plus prednisone or AA plus prednisone may be
resumed when safe to so as determined by the study physician in consultation with the sponsor
prior to resuming.
 COVID-19 infection should be reported to the sponsor and follow the usual Adverse
Event/Serious Adverse Event reporting requirements.
Reporting of Protocol Deviations
 All deviations from the study protocol will be reported based on standard guidance. If related
to the COVID-19 pandemic situation, these deviations will be recorded as COVID-19 related
by the sponsor.
COVID vaccine
 Subjects eligible for COVID vaccination should be vaccinated with non-live vaccines (mRNA
or non-replicating viral shell). Based on available information, there is no impact on the safety
or physical or mental integrity of the clinical study participants, or the scientific value of the
study. Please note that the type of vaccine, dates of first and second vaccinations, the doses
used, and any adverse events should also be recorded.
 Note: administration of non-live vaccines approved or authorized for emergency use (eg,
COVID 19) by local health authorities are allowed before or during this study. For guidance
on vaccination, please refer to recommendations for oncology study participants.13,22,38

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
101
Status: Approved, Date: 28 August 2023
10.6. Appendix 6: ECOG Performance Status
ECOG Grade Scale (with Karnofsky conversion)
0 
Fully active, able to carry on all predisease performance without restriction.
(Karnofsky 90-100)
1 
Restricted in physically strenuous activity but ambulatory and able to carry out work on a
light or sedentary nature, eg, light housework, office work. (Karnofsky 70-80)
2 
Ambulatory and capable of all self-care but unable to carry out any work activities. Up
and about more than 50% of waking hours. (Karnofsky 50-60)
3 
Capable of only limited self-care; confined to bed or chair more than 50% of waking
hours. (Karnofsky 30-40)
4 
Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
(Karnofsky 10-20)
5 
Dead. (Karnofsky 0)

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
103
Status: Approved, Date: 28 August 2023
10.8. Appendix 8: Anticipated Adverse Events
An anticipated event is an adverse event (serious or nonserious) that commonly occurs as a
consequence of the underlying disease or condition under investigation (disease-related) or
background regimen. For the purposes of this study, the following events will be considered
anticipated events:
Disease-specific Events 
ADT Events
erectile dysfunction 
depression
hematuria 
gynecomastia
incontinence 
libido decreased
lymphoedema 
osteoporosis
nocturia 
sexual dysfunction
painful ejaculation  
testicular atrophy
prostatic specific antigen increased
urinary flow decreased
urinary hesitation
urinary tract obstruction
Reporting of Anticipated Events
All AEs will be recorded in the eCRF regardless of whether considered to be anticipated events
and will be reported to the sponsor as described in Section 10.4 Appendix 4 Adverse Events:
Definitions and Procedures for Recording, Evaluating, Follow-Up, and Reporting. Any anticipated
event that meets serious criteria will be reported to the sponsor as described in Section 10.4
Appendix 4 Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow-Up,
and Reporting. Each anticipated event will be assessed by the investigator at the individual case
level and if considered to be drug-related will undergo expedited reporting (if appropriate) per
applicable clinical trial legislation to Health Authorities and IRB/ECs If an anticipated event is
considered disease-related or not related to study drug the event will be exempt from expedited
reporting.
To meet US regulatory clinical trial legislation, the sponsor will perform aggregate review of
anticipated events as outlined below, and if determined to be drug-related will implement expedited
reporting of these events to Health Authorities and IRBs/ECs. If an interim analysis of trial results

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
104
Status: Approved, Date: 28 August 2023
leads to an unblinded, aggregate review of safety data by the study team, the sponsormay terminate
the review of pre-specified anticipated events outlined above.
Safety Assessment Committee (SAC)
A Safety Assessment Committee (SAC) will be established to perform reviews of pre-specified
anticipated events at an aggregate level. The SAC is a safety committee within the sponsor’s
organization that is independent of the sponsor’s study team. The SAC will meet to aid in the
recommendation to the sponsor’s study team as to whether there is a reasonable possibility that an
anticipated event is related to the study medication based on a review of the aggregate data by arm.
Statistical Analysis
Details of statistical analysis of anticipated events, including the frequency of review and threshold
to trigger an aggregate analysis of anticipated events will be provided in a separate Anticipated
Events Safety Monitoring Plan.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
105
Status: Approved, Date: 28 August 2023
10.9. Appendix 9: Child-Pugh Criteria

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
106
Status: Approved, Date: 28 August 2023
10.10. Appendix 10: Open-label Extension Phase
The Open-label Extension (OLE) Phase may be initiated when at least Amendment 2 is approved
at the site and upon notification from the sponsor to unblind subjects and initiate the start of the
OLE. The purpose of the OLE Phase is to allow subjects to receive open-label study treatment.
Hereafter the term “study treatment” refers to either FDC, niraparib and/or AAP drug formulations
as relevant to the subject entering OLE.
Subjects who are participating in the Treatment Phase of the study and who are still on study
treatmentwill be offered the option to receive open-label study treatmentif theymeet the eligibility
criteria below. Eligible subjects who were randomized to placebo+AAP may be offered the option
to receive open-label niraparib+AAP (investigators can choose to maintain subjects on AAP
alone). Eligible subjects who were randomized to niraparib+AAP may continue open-label study
treatment.
Subjects with a study drug interruption at the time of entry to OLE due to an adverse event should
continue to have their study treatment held until resolution of the adverse event and the investigator
should discuss with the sponsor the appropriate dose of niraparib and/or AAP to be administered
in the OLE Phase. If the subject has study drug withheld due to an adverse event, all 4 eligibility
criteria listed below would need to be met for the subject to start study treatment in the OLE Phase.
Subjects who discontinued either niraparib or AAP due to an adverse event may continue to receive
the same study treatment that they are currently taking if they meet eligibility criteria 1 to 3 listed
below.
Subjects who have already ended study treatment and are in the Follow-up Phase of the main study
may not resume study treatment and may be followed for select study endpoints such as survival.
Subjects will be followed per the schedule of procedures provided in the table below in this
appendix until a reason for discontinuation of study treatment has been met (see protocol
Section 7.1), the sponsor initiates the Long-term Extension (LTE) Phase, or until further
notification by the sponsor of a different means for continued supply of study treatment, whichever
occurs first.
Subjects in OLE may be moved to LTE if sponsor approval was obtained (Appendix 11: Long-
term Extension Phase).
Eligibility Criteria for Subjects who cross-over to OLE treatment after Unblinding
Subjects eligible to receive either open-label study treatment should meet the criteria below within
28 days prior to starting OLE treatment. Re-evaluation of out-of-range criteria may be permitted
after discussion with the sponsor.
1. Still participating in the Treatment Phase of the study
2. Willing and able to provide informed consent to participate in the OLE Phase

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
107
Status: Approved, Date: 28 August 2023
3. Not have niraparib or FDC withheld for ≥3 consecutive months due to an adverse event in the
double-blind Treatment Phase immediately prior to OLE Phase consent (not applicable for
those continuing AAP only in OLE)
4. Subjects crossing-over to open-label niraparib+AAP from placebo+AAP and those entering
OLE after having study treatment held for an adverse event should have adequate organ
function and performance status as outlined in the original protocol (Section 5.1 Criteria 6 and
11). All other subjects entering OLE may continue with organ function testing and
management with adverse events according to where they fall in the Schedule of Activities
(Table 2) from the Treatment Phase. Additional details are provided in the schedule of
procedures in the table below in this appendix.
Testing through local and central laboratories are permitted for OLE eligibility. After eligibility,
only local laboratory testing should be performed.
Study Treatment Administration
Open-label study treatment
Study treatment will be taken orally on an outpatient basis and a treatment cycle is defined as
28 days. Sufficient study drug for each treatment cycle will be distributed as specified in
Section 6.1.2 of the protocol. Dose modifications for toxicity are provided in Section 6.5 of the
protocol.
Subjects on a lower dose of study treatment in the Treatment Phase of the study should continue
the same dose during the OLE Phase unless approved in advance with the sponsor’s medical
monitor (see protocol Section 6.5).
Androgen Deprivation Therapy (ADT) Administration
ADT should be continued as per local practice.
Prohibitions and Restrictions
Refer to protocol Sections 6.8.2 and 6.8.3.
Study Procedures for the Open-label Extension
Subjects who meet the eligibility criteria as outlined above will be permitted to start open-label
study treatment. Cycle 1 Day 1 of the OLE should follow the last cycle in the double-blind
Treatment Phase for those crossing over to open-label niraparib+AAP  from placebo+AAP.
Subjects who enter OLE continuing the same study treatment they received in the Treatment Phase
(ie, niraparib+AAP, niraparib only, or AAP only) will continue with cycles numbered sequentially
from the last cycle received while in the main study (ie, if the last cycle in the Treatment Phase
was Cycle 15, the first OLE cycle will be Cycle 16). Subjects should follow the schedule of
procedures provided in the table below in this appendix.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
108
Status: Approved, Date: 28 August 2023
Blood samples for serum chemistry and hematology should be collected from a local laboratory as
specified in the table below in this appendix. The investigator should document review of the
laboratory results and record clinically relevant changes in the AE section of the eCRF  (eg,
laboratory abnormalities leading to dose interruptions, dose changes, or permanent study drug
withdrawal). Unscheduled laboratory assessments may be performed as required.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
110
Status: Approved, Date: 28 August 2023
10.11. Appendix 11: Long-term Extension Phase
The LTE Phase will be initiated when at least Amendment 2 is approved at the site and upon
notification from the sponsor to start LTE. The purpose of the LTE Phase is to provide study
treatment to subjects, while minimizing the burden of data collection.
Subjects who are still on study treatment will be offered the option to continue in the LTE Phase
if they meet the eligibility criteria below.
Subjects will continue the study treatment that they were receiving at the time of transition to LTE.
Subjects who had discontinued study treatment and are in  the Follow-up Phase will be
discontinued from the study upon the start of the LTE.
Subjects will be followed per the schedule of procedures provided in the table below in this
appendix  until a reason for discontinuation of study treatment has been met (see protocol
Section 7.1), or until further notification by the sponsor of a different means for continued supply
of study treatment, whichever occurs first.
LTE Eligibility Criteria:
1. Still receiving study treatment
2. Willing and able to provide informed consent to participate in the LTE Phase
Study Treatment Administration
Open-label study treatment
Study treatment will be taken orally on an outpatient basis and a treatment cycle is defined as
28 days. Sufficient study  drug for each treatment cycle will be distributed as specified in
Section 6.1.2 of the protocol. Dose modifications for toxicity are provided in Section 6.5 of the
protocol.
Subjects will continue the study treatment that they were receiving at the time of transition to LTE.
Androgen Deprivation Therapy (ADT) Administration
ADT should be continued as per local practice.
Prohibitions and Restrictions
Refer to protocol Sections 6.8.2 and 6.8.3.
Study Procedures for the Long-term Extension
All subjects continuing in the LTE will follow the schedule of procedures provided in the table
below in this appendix.
Investigators should monitor and assess the subjects for response, safety, and disease progression
according to routine practice and local label requirements. Timing of assessments is at the

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
112
Status: Approved, Date: 28 August 2023
10.12. Appendix 12: Protocol Amendment History
The Protocol Amendment Summary of Changes Table for the current amendment is located
directly before the Table of Contents (TOC).
Amendment 3 (09 February 2023)
Overall Rationale for the Amendment:  To revise the sample size based on emerging data from results
of clinical trials with PARP inhibitors in prostate cancer.
The changes made to the clinical protocol 67652000PCR3002 as part of Protocol Amendment 3 are listed
below, including the rationale of each change and a list of all applicable sections. Changes made in previous
protocol amendments are listed in Section 10.12 Appendix 12: Protocol Amendment History.
Section Number 
and Name
Description of Change 
Brief Rationale
1.1. Synopsis
(Number of
Participants,
Efficacy);
1.2. Schema;
4.1. Overall Design;
9.2. Sample Size
Determination
The number of participants was updated from ‘788’
to ‘692’.
To revise the sample size based on
emerging data from other recent
clinical trials with PARP inhibitors
in prostate cancer.
1.1. Synopsis
(Overall Design);
4.1. Overall Design;
8. Study
Assessments and
Procedures
Text added: “Patients with radiographic
progression can remain on therapy if still receiving
clinical benefit.”
To clarify reasons for treatment
discontinuation.
1.3. Schedule of
Activities (SoA)
(Table 1)
Text added: “if test is available from the sponsor” 
To clarify circumstances when
samples should be collected.
1.3. Schedule of
Activities (SoA)
(Table 2);
8. Study
Assessments and
Procedures;
8.8. Qualitative Exit
Interview
Qualitative Exit Interview was added as a sub-
study.
To update protocol with the
addition of a Qualitative Exit
Interview sub-study.
1.3. Schedule of
Activities (SoA)
(Table 2);
8.5. Genetics;
8.6.1.2. Plasma for
DNA
Text added: “where local regulations permit” 
To clarify circumstances when
samples should be collected.
1.3. Schedule of
Activities (SoA)
(Table 2);
5. Study Population;
10.2. Appendix 2:
Regulatory, Ethical,
and Study Oversight
Considerations
(Informed Consent
Process)
Prescreening eligibility criterion (#1) was modified
as written informed consent is required.
To clarify written informed consent
required.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
113
Status: Approved, Date: 28 August 2023
Section Number
and Name
Description of Change 
Brief Rationale 
1.3. Schedule of
Activities (SoA)
(Table 2);
7.1. Discontinuation
of Study Medication
The term ‘radiographic progression’ was changed
to ‘investigator-assessed radiographic progression’.
To provide further clarification.
1.3. Schedule of
Activities (SoA)
(Table 2);
10.2. Appendix 2:
Regulatory, Ethical,
and Study Oversight
Considerations
(Informed Consent
Process)
Text was added to clarify that reconsent may be
obtained remotely/virtually as per sponsor
procedures and in accordance with local
regulations.
To clarify circumstances when
other forms of reconsenting beyond
in person may be permitted.
2.2.3. Summary of
Available Clinical
Data for Niraparib
and AA Plus
Prednisone in
Prostate Cancer;
2.3. Benefit-Risk
Assessment;
4.3. Justification for
Dose
Added language regarding Study
64091742PCR3001 (MAGNITUDE) and the Phase
3 PROpel study.
Updated with emerging data from
PARP inhibitor trials in prostate
cancer. Also provides rationale for
stopping enrollment of participants
with CDK12-only alterations.
2.3. Benefit-Risk
Assessment;
Text was added to indicate that participants with
CDK12-only alterations are no longer being
enrolled in Study 67652000PCR3002.
Updates to gene alterations
permitted for eligibility allowed in
prior version of the protocol and
specific language is added to reflect
this change for CDK12-only
alterations.
5. Study Population 
Figure 2 Determination of Molecular Eligibility
was updated.
To clarify samples collected and
testing performed.
6.5. Dose 
Modification  
Text and table content revised. Text added to
define study medication terms used in table. Dose
modification text modified to allow resuming both
niraparib and AA concurrently after resolution of
toxicity when both had been held. Option to use
AA 750 mg dose removed (also in Table 6).
To clarify dose modification
guidelines.
6.5.1. Posterior 
Reversible 
Encephalopathy
Syndrome (PRES)
Text added: “Patients can remain on study and
continue to receive AAP.”
To clarify that patients can continue
to receive AAP if diagnosis of
PRES is confirmed.
6.8.1. Permitted 
Supportive Care and 
Interventions 
Text added: “Prednisone dose increase by 5mg/day
is permitted to manage refractory mineralocorticoid
related toxicities and should be documented in the
study medication eCRF.”
To align with the language in other
documents.
8.1.1. Evaluations 
for Primary Efficacy 
Assessment 
Text added: “Blinded Independent Central Review
of imaging scans may be ceased upon Sponsor
decision communicated to investigators by letter.”
To clarify the mechanism to
discontinue imaging scan
submission.
8.1.2.1. Patient 
Reported Outcomes 
Text added: “In rare circumstances, such as in case
of technical issues that cannot be resolved during
the visit and as a last resort where other options for
electronic completion have been explored and
deemed not feasible, a paper questionnaire should
be completed by the participant, and submitted to
To indicate that ePRO should be
completed electronically and to
clarify exceptions for paper
questionnaires.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
114
Status: Approved, Date: 28 August 2023
Section Number 
and Name
Description of Change 
Brief Rationale
the vendor by site staff. Every effort should be
made to have the ePRO completed by patient
electronically.”
8.6.1.2. Plasma for 
DNA  
Text added: “Plasma samples may also be used to 
develop tests/assays related to niraparib and AA 
and prostate cancer.” 
To provide information regarding
how collected samples may be
used.
9.2. Sample Size 
Determination  
Text added: “Long term survival follow-up will 
continue until approximately
 events have 
been observed. 
”
To update timing of efficacy
analysis based on emerging data.
9.5. Interim 
Analysis for Overall 
Survival
The number of planned formal interim analyses 
was updated. 
To revise the number of analyses
based on emerging data.
10.1. Appendix 1 
The list of abbreviations was updated. 
The list is updated to include new
terms and abbreviations used in
revised text.
10.7. Appendix 7: 
Clinical Laboratory 
Tests 
Text added: “Starting from C1D1, laboratory 
assessments may be performed up to 3 days prior 
to study visit. If screening laboratory safety
assessments are done within 3 days of C1D1, no
need to repeat on C1D1.”
To clarify timeline permitted for
testing.
10.10. Appendix 10: 
Open-label 
Extension Phase 
Footnotes added to clarify no central laboratory or 
central imaging assessments performed during 
Open-Label Extension. 
To clarify how disease assessments
will be performed during Open-
label Extension phase.
10.12. Appendix 12: 
Protocol 
Amendment History
The protocol amendment 2 summary table was 
moved to Appendix 12. 
To align with the template
requirement.
Protocol 
Amendment 
Summary of 
Changes 
Amendment 2 
In protocol amendment 2, the rationale for adding 
MACE in Section 8.3.7. was to address known 
AESIs related to abiraterone acetate and not
niraparib. Therefore, MACE is not a new risk
associated with study treatment.
To clarify rationale for addition of
MACE in protocol amendment 2.
Throughout the 
protocol 
Minor grammatical, formatting, or spelling changes 
were made.
Minor errors were noted
CCI
CCI

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
115
Status: Approved, Date: 28 August 2023
Amendment 2 (25 October 2021)
Overall Rationale for the Amendment:  To modify eligibility criteria based on investigator feedback to
facilitate enrollment, to allow additional forms of testing for HRR alterations, and to clarify toxicity
management guidelines to comply with the changes requested by the health authorities.
Section Number 
and Name
Description of Change 
Brief Rationale
Synopsis (Biomarker 
Evaluations); 1.3. 
Schedule of Activities 
(SOA): Table 1; 4.2.
Scientific Rationale for
Study Design; 5. Study
Population (Figure 2 and
#4); 8.6.1.2. Plasma for
DNA
Additional text and footnote related to 
biomarker evaluations using plasma sample 
were added.
To clarify plasma testing for
biomarker samples.
Synopsis 
(Pharmacogenomic 
[DNA] Evaluations); 8.5.
Genetics
The text ‘or saliva’ was added. 
To include saliva sample collection
for pharmacogenomic evaluations.
1.3. Schedule of 
Activities (SOA): Table 2 
The screening period was revised from 
≤28 days to ≤35 days. 
To allow more time for completion
of screening evaluation
1.3. Schedule of 
Activities (SOA): Table 2 
The computed tomography (CT) or magnetic 
resonance imaging (MRI) and Technetium- 
99m (99mTc) Bone Scan were scheduled to
occur every 4 months in the Follow-up Phase
(until radiographic progression).
To align with the text in the body of
the protocol.
4.2. Scientific Rationale 
for Study Design  
The title of Table 4 was revised. 
To clarify that eligible homologous
recombination repair (HRR) gene
alterations will be tested during the
Prescreening Phase.
5. Study Population (#3) 
The text ‘histologically confirmed’ was 
deleted and ‘diagnosis of ‘was added. 
To keep all other diagnostic
methods open for diagnosis, in
addition to histology, at
prescreening.
5. Study Population (#4) 
The text related to blood or saliva sample for 
HRR gene alterations status determination
was deleted.
To avoid repetition.
5.1. Inclusion Criteria 
(#2) 
The inclusion criterion was revised to add the 
word ‘pathological diagnosis’. 
To specify that participants with
metastatic prostate adenocarcinoma
are included in the study.
5.1. Inclusion Criteria 
(#4) 
The inclusion criterion was revised to add 
text related to documentation of metastatic 
disease. 
To clarify further the documentation
of metastatic disease and include
patients without bone lesions.
5.1. Inclusion Criteria 
(#8) 
The inclusion criterion for participants who 
have received prior docetaxel treatment was 
revised to include participants who received
last dose of docetaxel ≤3 months prior to
randomization.
To allow adequate recovery from
prior docetaxel therapy.
5.1. Inclusion Criteria 
(#9) 
The text was amended to extend prior 
treatment with abiraterone acetate plus 
prednisone (AAP) (from 30 to 45 days). 
To increase run in for AAP to allow
inclusion of a greater number of
participants from referrals.
Prior treatment with ketoconazole for 
prostate cancer was allowed for a maximum 
of two weeks in the metastatic castration-
sensitive prostate cancer (mCSPC).
To allow inclusion of a greater
number of participants.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
116
Status: Approved, Date: 28 August 2023
Section Number 
and Name
Description of Change 
Brief Rationale
5.1. Inclusion Criteria 
(#10) 
The text was amended for allowed prior 
treatments for localized prostate cancer. 
To better define allowed prior
treatments for localized prostate
cancer and time frames.
5.2. Exclusion Criteria 
(#3) 
The exclusion criterion of prior AAP 
treatment timeline was modified. 
To allow inclusion of a greater
number of participants.
5.2. Exclusion Criteria 
(#18) 
Patients with moderate hepatic impairment 
Class B were also excluded along with 
patients with severe hepatic impairment 
Class C per the Child-Pugh classification
system.
To exclude patients with moderate
or severe hepatic impairment by
Child-Pugh criteria.
5.4. Screen Failures; 8. 
Study Assessments and 
Procedures; 10.7. 
Appendix 7: Clinical
Laboratory Tests
Coagulation panel was added to the list of 
clinical laboratory tests to be performed at 
screening. 
To ensure exclusion of patients with
liver dysfunction per Child-Pugh
exclusion criteria.
6.1. Study Medication(s) 
Administered 
The definition of study medication was 
revised. 
To include Fixed Dose Combination
(FDC) (Niraparib + AA) as a study
medication
6.5. Dose Modification  
The text related to non-hematologic toxicities 
due to niraparib or AA was added and table 
for only niraparib dose modifications due to 
non-hematologic adverse events was deleted. 
To align with other niraparib
protocols and to add general
non-hematologic guidelines for both
niraparib and AA for sites to
reference (previous table only had
guidelines for niraparib).
The text “If hypokalemia persists despite 
optimal potassium supplementation and 
adequate oral intake, the dose of prednisone
may be increased by 5 mg/day and
documented in the study medication
electronic case report form.” was added.
To indicate that prednisone can be
used for all toxicity grades.
6.5. Dose Modification 
(Table 8) 
The hypertension guidelines were deleted. 
No longer needed as dose
modification for hypertension is
now covered by the general non-
hematologic toxicity management
instructions.
6.5. Dose Modification  
Hematological Toxicities 
The text was modified to delete 
“hemoglobin”. 
To clarify inconsistencies in toxicity
management.
6.8.1. Permitted 
Supportive Care and 
Interventions 
The text ‘Increase of prednisone to 10 
mg/daily if needed to manage 
mineralocorticoid toxicity related to AA’ was 
added.
To allow physician discretion to
manage mineralocorticoid toxicity
related to AA as needed.
6.8.1. Permitted 
Supportive Care and 
Interventions 
6.8.2. Prohibited 
Concomitant Therapies 
The text “Bisphosphonates or denosumab at 
doses for osteoporosis prophylaxis” was 
deleted. 
The text “Bisphosphonates or denosumab for 
management of bone metastasis unless such 
therapy was started >28 days prior to 
randomization and participants have been on 
a stable dose.” was deleted.
As the risk-benefit for
bisphosphonates supports allowance
as concomitant therapy to prevent
potential bone complications,
particularly due to associated
toxicity from long term ADT, this
restriction has been removed.
6.8.2. Prohibited 
Concomitant Therapies 
Ketoconazole was removed as  an example 
from the list of prohibited concomitant 
therapies.
Already covered under CYP17
inhibitors.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
117
Status: Approved, Date: 28 August 2023
Section Number 
and Name
Description of Change 
Brief Rationale
8. Study Assessments and 
Procedures 
The number of cycles was corrected from ’24 
to 41’. 
To correct the mistake and align
with the average number of cycles
versus patient population.
The text ‘or initiation of subsequent therapy’ 
was deleted from the Follow-up Phase. 
To continue to monitor patients,
regardless of subsequent treatment,
until meets primary end point of
radiographic progression-free
survival (rPFS).
8.2.2. Vital Signs 
The text ‘blood pressure and heart rate 
monitoring can occur at clinic visit or may 
also be reported to the site by a home nurse
or other qualified medical professionals
approved by the investigator and authorized
to examine patients.’ was added.
To provide further instructions on
home monitoring.
8.3.7. Adverse Events of 
Special Interest 
The adverse event ‘Cataract’ was deleted 
from the list of adverse events of clinical 
interest and ‘Major Adverse Cardiovascular 
Events (MACE)’ were added. 
To update the list of adverse events
of clinical interest based on the
safety findings from other niraparib
studies.
10.5. Appendix 5: 
Guidance on Study 
Conduct During the
COVID-19 Pandemic
The text related to COVID vaccine was 
added. 
To provide guidance related to
COVID vaccine.
10.7. Appendix 7: 
Clinical Laboratory Tests 
The footnote was edited to add “to ensure 
patient still meets eligibility criteria.” 
To ensure safety labs are drawn
within 14 days of first dose.
10.9. Appendix 10: Open- 
label Extension Phase 
10.10. Appendix 11: 
Long-term Extension 
Phase
These appendices are added and numbers 
were updated. 
To add details of the open-label and
long-term extension phases in
Appendix 10 and Appendix 11,
respectively.
10.12. Appendix 12: 
Protocol Amendment 
History
The protocol amendment 1 summary table 
was moved to Appendix 12. 
To align with the template
requirement.
Throughout the protocol 
Minor grammatical, formatting, editorial, or 
spelling changes were made.
Minor errors are noted.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
118
Status: Approved, Date: 28 August 2023
Amendment 1 (21 December 2020)
Overall Rationale for the Amendment: To update safety monitoring and guidance based on updates to
niraparib core safety information.
Section number 
and Name
Description of Change 
Brief Rationale
1.1. Synopsis (Overall 
Design, Treatment 
Groups and Duration);
4.1. Overall Design
The word ‘basis’ was deleted, and ‘ratio’ was 
added. 
To specify the proportion
throughout protocol.
1.1. Synopsis 
(Treatment Groups and 
Duration); 6.1.2. Study
Medication
The words ‘Experimental’ and ‘Control’ were 
added. 
To define the study drug
combinations.
4.2. Scientific 
Rationale for Study 
Design
The word ‘comparator’ was deleted, and
‘control’ was added.
1.1. Synopsis 
(Biomarker 
Evaluations); 1.3. 
Schedule of Activities 
(Table 1); 4.2.
Scientific Rationale for
Study Design; 5.1.
Inclusion Criteria (#5)
The text regarding local tests for biomarker 
evaluations was modified. 
To clarify collection of archival
and fresh tissue samples only if
local laboratory results are
provided at prescreening.
5. Study Population 
Figure 2 Determination of Molecular Eligibility
was updated.
Prescreening eligibility criterion (#4) was
modified.
1.1. Synopsis 
(Biomarker
Evaluations); 1.3.
Schedule of Activities
(Table 1); 4.2.
Scientific Rationale for
Study Design; 5. Study
Population
Definition for local test was added. 
To clarify the local test.
1.1. Synopsis 
(Pharmacogenomic 
[DNA] Evaluations);
8.5. Genetics
The text ‘or somatic’ was deleted. 
To clarify that this pertains only to
germline mutations.
1.1. Synopsis 
(Pharmacogenomic 
[DNA] Evaluations);
8.5. Genetics
The word ‘optional’ related to research samples 
was deleted. 
To specify that research sample is
not optional
1.2. Schema (Figure 1) 
The specific mention of assays to determine gene 
eligibility was deleted from the schematic 
overview of the study. 
To accommodate participants with
genes selected using any genetic
tests rather than any specific test.
1.3. Schedule of 
Activities (Table 1) 
The text ‘If not eligible by tissue, can be enrolled 
if germline (blood or saliva) result is positive’ 
was deleted. 
To clarify that patients are eligible
for enrollment by germline results
if tissue results are negative or
inconclusive.
1.3. Schedule of 
Activities (Table 2) 
The treatment cycles 4 to 12 and 13 to 24 were 
merged. 
To combine the cycles with
similar schedule of activities.
Cycle 25 was moved to the next phase of
treatment (till end-of-treatment [EoT]).

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
119
Status: Approved, Date: 28 August 2023
Section number
and Name
Description of Change 
Brief Rationale 
1.3. Schedule of 
Activities (Table 2); 
8. Study Assessments
and Procedures
The ±7 days window for cycles 13 to 25 was
shortened to ±3 days.
To reduce visit window to align
with earlier cycles.
1.3. Schedule of 
Activities (Table 2); 
The randomization visit at Cycle 1 Day 1 was
deleted.
To specify that randomization will
occur before Cycle 1 Day 1.
1.3. Schedule of 
Activities (Table 2); 
8.1.2.1. Patient 
Reported Outcomes
The text specifying completion of patient
reported outcomes (PRO) remotely at follow-up
visit was deleted.
To clarify that all the visits have
remote option.
1.3. Schedule of 
Activities (Table 2) 
The PRO measurement system ‘Patient-reported
Outcomes Common Terminology Criteria for
Adverse Events (PRO-CTCAE)’ and text
‘PRO-CTCAE for US sites only ‘were added.
The text ‘during the follow-up phase’ was
deleted.
To evaluate symptomatic toxicity
in participants in the United States
(US) as a pilot.
3. Objectives and 
Endpoints 
The PRO measurement system ‘PRO-CTCAE’
was added.
8.1.2.1.4. PRO-CTCAE The text related to PRO-CTCAE was added
1.3. Schedule of 
Activities (Table 2); 
8.2.2. Vital Signs 
Added additional timepoints for vital signs
(blood pressure [BP] and heart rate)
measurements; additionally, methods for BP
collection were clarified.
To align with niraparib
Investigator’s brochure (IB) and
product information.
1.3. Schedule of 
Activities (Table 2) 
Added weekly hematology assessments for the
first month (Cycle 1).
To align with niraparib product
information.
The text ‘Potassium on Day 15 of Cycle 1, 2, and
3’ was deleted from chemistry assessments and
‘potassium’ was added along with hematology.
To clarify that potassium
assessment will be performed at
the same timepoints as
hematology.
The text ‘prior to randomization’, ‘while patient
is on androgen deprivation therapy (ADT)’, and
‘these prostate-specific antigen (PSA) samples
can be obtained as SOC or as part of the Covance
screening tests’ was added in the notes column.
If patients start ADT prior to
randomization, PSA is going to be
captured as part of SOC.
Coagulation panel and the text related to its
sample collection timepoint was added.
To ensure exclusion of patients
with coagulation abnormalities at
screening.
The text in the notes for plasma for ribonucleic
acid (RNA) and deoxyribonucleic acid (DNA)
‘End-of-treatment (EoT) samples should be
collected when feasible’ was added.
To clarify the collection of plasma
for RNA and DNA sample.
The treatment cycles 1 to 3 were merged for
biomarker analysis.
To specify that biomarker analysis
could be conducted from Cycle 1
to Cycle 3.
Modifications were made to specify participants
willingness to provide archival or fresh tissue
sample and non-requirement of sample collection
from participants with results from sponsor’s
commercial tumor tissue test.
The text ‘However, it is not a protocol violation
if no tissue is available or cannot be collected’
was deleted from the notes.
To clarify the expectations on
tumor collection from participants
who do not undergo sponsor’s
biomarker testing.
The text ‘point without constituting a protocol
deviation’ was deleted.
To delete specific mention of
protocol deviation.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
120
Status: Approved, Date: 28 August 2023
Section number 
and Name
Description of Change 
Brief Rationale
2. Introduction; 2.3. 
Benefit-Risk 
Assessment; 11. 
References 
The IB for niraparib/ abiraterone acetate (AA) 
fixed dose combination (FDC) was referenced in
the text and citation was added in the reference
list.
To include niraparib/AA FDC IB.
6.1.2. Study Medication  ‘Pharmacy Manual’ was deleted and IB for
niraparib/ AA FDC was referenced in the text
and citation was added in the reference list.
2.2.3 Summary of 
Available Clinical Data 
for Niraparib and AA,
Plus Prednisone in
Prostate Cancer
The text ‘is synergistic’ was changed to ‘may be 
beneficial’. 
To align with the language in
other documents.
4.2. Scientific 
Rationale for Study 
Design  
The specific mention of letter as mode of 
communication for any biomarker-related 
enrollment changes to investigator was deleted. 
To keep open any mode of
communication for reporting any
biomarker-related enrollment
changes to the investigator.
Additional information regarding biomarker
collection was added.
To update the biomarker
collection information.
5. Study Population 
The text regarding local tests for biomarker
evaluations was deleted.
To avoid repetition.
5.1. Inclusion Criteria 
(#3)
Inclusion criterion #3 was deleted
5.1. Inclusion Criteria 
(#8) 
Word ‘and’ was replaced with ‘or’. 
To specify that either assessment
of imaging or PSA is sufficient,
both are not required.
5.1. Inclusion Criteria 
(#11) 
The unit for platelet count was corrected, the 
serum albumin value at screening was deleted 
and the text ‘as determined by the medical
monitor’ was deleted.
To align with the health authority
requirement.
5.1. Inclusion Criteria 
(#14 and #15) 
Amended text to indicate that study participants 
must agree to use an adequate contraceptive 
method, the details of which have been included 
under Section 5.3. Lifestyle Considerations. 
Clarified restrictions related to sperm donation.
To align with the definitions and
methods of contraception
described in the Clinical Trials
Facilitation and Coordination
Group (CTFG) guidelines.
5.3. Lifestyle 
Considerations 
Bullet #3 has been added to further describe
highly effective contraceptive methods.
5.2. Exclusion Criteria 
(#15)
Criterion #15 was deleted 
To avoid repetition.
5.2. Exclusion Criteria 
(#17 and #18) 
New criteria #17 and #18 were added to exclude 
patients with liver disease and severe hepatic 
impairment.
To exclude patients with moderate
or severe hepatic impairment.
5.4. Screen Failures 
The text ‘Individuals who do not meet the criteria 
for participation in this study (screen failure)
may be rescreened.’ was deleted.
To avoid repetition.
6.1. Study Medication 
(s) Administered; 6.1.2. 
Study Medication
The text related to use of single agent product if 
the FDC formulation is not available was deleted. 
To delete the redundant text as
now FDC formulation is available.
6.1.2. Study Medication 
(Table 5) 
Text regarding administration of food with 
prednisone/prednisolone was added. 
To clarify food requirement for
prednisone/prednisolone.
Text regarding acceptability of prednisolone in 
case participants are unable to take prednisone 
was added.
To clarify substitute acceptability
for prednisone/prednisolone.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
121
Status: Approved, Date: 28 August 2023
Section number 
and Name
Description of Change 
Brief Rationale
6.5. Dose Modification  
Text ‘no dose reduction will be allowed for liver 
function test (LFT) related toxicity’ was deleted. 
To correct the error text in the
original protocol.
6.5. Dose Modification  
Added instruction that niraparib must be 
discontinued for non-hematologic 
treatment-related Grade ≥3 toxicities lasting 
more than 28 days while the participant is 
administered niraparib 100 mg once daily.
To clarify that the lowest dose of
niraparib is 100 mg; further dose
reduction is not allowed per
protocol.
6.5. Dose Modification 
(Table 8) 
The information regarding general dose 
reduction guidelines was revised 
To update general dose reduction
guidelines.
The dose modification information regarding 
non-hematologic adverse reactions was added. 
To add instructions regarding
niraparib
withhold/resume/discontinuation
in the event of non-hematologic
>Grade 3 treatment-related
adverse reaction and clarify that
the lowest dose of niraparib is
100 mg; further dose reduction is
not allowed per protocol.
Hematologic Toxicities Section: added/clarified 
dosing modification instructions for participants 
who experience: 
 Inadequate recovery of platelet counts, 
neutrophil counts, and/or hemoglobin levels. 
 Acute myeloid leukemia or myelodysplastic 
syndrome. 
To clarify that niraparib will be
discontinued in participants
meeting criteria for dose reduction
who are already at the lowest dose
of niraparib. To clarify
instructions for participants who
develop bone marrow
abnormalities.
The additional detailed text regarding diagnosis 
of myelodysplastic syndrome (MDS) was 
updated. 
The management of MDS is
updated to be consistent with the
latest niraparib Company Core
Data Sheet (CCDS).
An additional action required to be taken on 
reoccurrence of Grade 3 hypertension was added. 
To update the hypertension
guidelines.
6.5. Dose Modification 
(Table 8); 8.3.7. 
Adverse Events of 
Special Interest 
The text regarding the adverse event of decreased 
platelet, hemoglobin, and/or neutrophil count 
was modified. 
To clarify that platelet,
hemoglobin, and/or neutrophil
count can be decreased
independently of one another.
6.5. Dose Modification 
(Table 8) 
The word ‘prophylactic’ was deleted. 
To align with the new guidance.
The word ‘should’ was deleted and ‘must’ was
added.
6.5.1. Posterior 
Reversible 
Encephalopathy 
Syndrome (PRES) 
Added detailed information regarding posterior 
reversible encephalopathy syndrome (PRES) and 
instructions for discontinuation of niraparib if
PRES is diagnosed.
To align with recent core labeling
changes for niraparib.
6.7. Treatment of 
Overdose 
The information regarding actions to be taken in 
case of AA overdose was updated. 
To align with the United States
Prescribing Information (USPI)
for ZYTIGA.
The information regarding actions to be taken in 
case of prednisone overdose was added. 
To update the prednisone
treatment overdose information
The text ‘and in the prednisone product 
information’ was added. 
To include product information
for prednisone.
6.8.2. Prohibited 
Concomitant Therapies 
The text ‘other hormonal agents for cancer 
therapy, antineoplastic agents,
radiopharmaceuticals’ was deleted.
To avoid repetition.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
122
Status: Approved, Date: 28 August 2023
Section number 
and Name
Description of Change 
Brief Rationale
7.1. Discontinuation of 
Study Intervention  
A cross-reference to Section 6.5 (Dose 
Modification) was added. 
To provide cross-reference to
information on adverse events
relative to treatment
discontinuation.
7.2.1. Withdrawal From 
the use of Research 
Samples; 10.2. 
Appendix 2 
The word ’future’ was added and ‘optional’ 
related to research samples was deleted. 
To specify that research sample is
not optional, however participant
may withdraw consent for use of
samples for future research.
The repetitive text was deleted. 
To avoid redundancy.
8. Study Assessments 
and Procedures 
Cycle 25 was changed to Cycle 26. 
To align with the schedule of
activities (SOA).
8. Study Assessments 
and Procedures 
The text regarding standard of care procedures 
performed during screening phase was added. 
To update standard of care
procedures during screening phase
8.1.1.1. Criteria for 
Primary Endpoint 
The word ’baseline’ was deleted and ‘reference’ 
was added. 
To specify the purpose of the scan
at Week 8.
8.1.2.1. Patient 
Reported Outcomes 
The text ‘side effect bother’ was deleted and 
‘bothered by side effects’ was added.
To make grammatical correction.
8.3.4. Regulatory 
Reporting 
Requirements for 
Serious Adverse Events 
and Anticipated Events
The text ‘For the purposes of this study the 
following serious adverse events (SAEs) will be 
considered anticipated events’ was deleted.
The table for anticipated SAEs was deleted.
To delete the outdated list of
anticipated SAEs.
8.6.1. Evaluations, 
8.6.1.3. Tumor Tissue 
Analysis
Information regarding exploratory biomarkers 
was elaborated. 
To clarify the information
regarding exploratory biomarkers.
8.6.1.1. Plasma for 
RNA  
Text ‘will allow evaluation of’ was deleted and 
‘may be used to evaluate’ was added. 
To mention that the analysis of
plasma is optional.
10.1. Appendix 1 
The list of abbreviations was updated. 
The list is updated to include new
terms and abbreviations used in
revised text.
10.2. Appendix 2 
Word ‘will’ was deleted and ‘may’ was added. 
To suggest that informed consent
for research component is
optional.
Text ‘Refusal to participate in the optional 
research will not result in ineligibility for the 
study’ was deleted.
To suggest that sample collection
is mandatory.
10.7. Appendix 7 
The text ‘fasting’ regarding glucose was deleted. 
To clarify that any (not
particularly fasting) glucose
sample can be collected.
The text ‘screening only’ regarding albumin was 
deleted. 
To specify that albumin will be
collected at every visit with the
rest of the clinical chemistry
laboratory assessments and not
just at screening.
Added screening international normalized ratio 
(INR). 
To ensure exclusion of patients
with coagulation abnormalities in
the context of hepatic impairment
exclusion criterion #18.
10.8. Appendix 8 
Replaced the old table with new table of list of 
anticipated SAEs. 
To align with the Food and Drug
Administration (FDA)
requirement.
10.9. Appendix 9 
New Appendix 9 for Child-Pugh classification 
system was added and referenced in the 
exclusion criterion #18. 
To update the information
regarding the criteria for severe
hepatic impairment.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
123
Status: Approved, Date: 28 August 2023
Section number 
and Name
Description of Change 
Brief Rationale
10.10. Appendix 10: 
Protocol Amendment 
History
Updated to indicate the ‘Summary of Changes 
Table’ for the current amendment is available. 
To align with protocol amendment
requirements.
5.1. Inclusion Criterion 
(Criterion #13); 8. 
Study Assessments and 
Procedures; 8.3. 
Adverse Events,
Serious Adverse
Events, and Other
Safety Reporting; 8.3.1.
Time Period and
Frequency for
Collecting Adverse
Event and Serious
Adverse Event
Information; 8.3.3
Follow-up of Adverse
Events and Serious
Adverse Events; 10.2.
Appendix 2; 10.4.
Appendix 4; 10.5.
Appendix 5
Text has been revised, deleted, or added to align 
with the Janssen protocol template. 
Added text to allow remote consenting and
monitoring.
To align with the updates made to
the Janssen protocol template.
Title Page; 
Throughout the 
protocol 
Updated the confidentiality statement on the title 
page and the footer of the protocol. 
To update the confidentiality
statement and footer per latest
template.
Throughout the 
protocol 
‘Mutation(s)’ has been replaced with 
‘alteration(s)’at relevant places. 
Word ‘niraparib’ was added alongside FDC
formulation.
For consistency throughout the
protocol.
Consistent notation has been applied when 
referring to treatment regimen: niraparib and
abiraterone acetate (AA) plus prednisone (AAP).
For consistency.
Minor grammatical, formatting, editorial, or 
spelling changes were made.
Minor errors are noted.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
124
Status: Approved, Date: 28 August 2023
11. 
REFERENCES
1. 
Annala M, Struss WJ, Warner EW, et al. Treatment outcomes and tumor loss of heterozygosity in germline
DNA repair–deficient prostate cancer. Eur Urol. 2017;72(1):34-42.
2. 
Annala M, Vandekerkhove G, Khalaf D, et al. Circulating tumor DNA genomics correlate with resistance to
abiraterone and enzalutamide in prostate cancer. Cancer Discov. 2018;8(4):444-457.
3. 
Antonarakis E, Isaacsson-Velho P, Agarwal N, et al. CDK12-altered prostate cancer: Clinical features and
therapeutic outcomes to standard systematic therapies, PARP inhibitors, and PD-1 inhibitors. Poster presented
at: Annual Congress of the European Society for Medical Oncology, 27 Sep-01 Oct 2019, Barcelona Spain.
4. 
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA and Jemal A. Global cancer statistics 2018:
GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J
Clin. 2018;68:394-424.
5. 
Castro E, Romero-Laorden N, del Pozo A, et al. PROREPAIR-B: A prospective cohort study of the impact of
germline DNA repair mutations on the outcomes of patients with metastatic castration-resistant prostate
cancer. J Clin Oncol. 2019;37(6):490-503.
6. 
Cella D, Paul D, Yount S, et al. What are the most important symptom targets when treating advanced cancer?
A survey of providers in the National Comprehensive Cancer Network (NCCN). Cancer Invest.
2003;21(4):526-535.
7. 
Cella D, Nichol MB, Eton D, Nelson JB, Mulani P. Estimating clinically meaningful changes for the
Functional Assessment of Cancer Therapy--Prostate: results from a clinical trial of patients with metastatic
hormone-refractory prostate cancer. Value Health. 2009;12(1):124-129.
8. 
Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore.
1994;23(2):129-38.
9. 
Crocetti E. Epidemiology of prostate cancer in Europe. Joint Research Centre (online publication) 2015.
Accessed on 7 February 2020. Available at: https://publications.jrc.ec.europa.eu/repository/handle/JRC101382.
10. Daut RL, Cleeland CS, Flanery RC. Development of the Wisconsin Brief Pain Questionnaire to assess pain in
cancer and other diseases. Pain. 1983;17(2):197-210.
11. de Bono J, Logothetis C, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N
Engl J Med. 2011;364(21):1995-2005.
12. de Bono J, Mateo J, Fizazi K, et al. Olaparib for metastatic castration-resistant prostate cancer. N Engl J Med
2020; DOI: 10.1056/NEJMoa1911440.
13. Desai et al. COVID-19 vaccine guidance for patients with cancer participating in oncology clinical trials.
Nature Reviews. 2021;18:313 https://doi.org/10.1038/s41571-021-00487-z.
14. Dhawan M, Ryan CJ, Ashworth A. DNA repair deficiency is common in advanced prostate cancer: new
therapeutic opportunities. Oncologist. 2016;21(8):940-945.
15. Do K, Chen AP. Molecular pathways: targeting PARP in cancer treatment. Clinical Cancer Research.
2013;19(5):977-984.
16. Esper P, Mo F, Chodak G, et al. Measuring quality of life in men with prostate cancer using the functional
assessment of cancer therapy-prostate instrument. Urology. 1997;50(6):920-928.
17. EuroQol. EQ-5D. Available at: https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/. Accessed 30 March
2020.
18. Farmer H, McCabe N, Lord CJ, et al. Targeting the DNA repair defect in BRCA mutant cells as a therapeutic
strategy. Nature. 2005;434(7035):917-921.
19. FDA: Drug Development and Drug Interactions: Table of Substrates, Inhibitors, and Inducers. Available at:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/u
cm093664.htm. Accessed 25 March 2020.
20. Fizazi K, Tran N, Fein L, et al. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer.
N Eng J Medicine. 2017;377(4):352-360.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
125
Status: Approved, Date: 28 August 2023
21. Fizazi K, Tran NP, Fein L. Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk
metastatic castration-sensitive prostate cancer (LATITUDE): final overall survival analysis of a randomised,
double-blind, phase 3 trial. The Lancet Oncology. 2019;20(5):686-700.
22. Garassino, MC, et al. The ESMO call to action on COVID-19 vaccinations and patients with cancer:
Vaccinate. Monitor. Educate. Ann. Oncol. 2021. https://doi.org/10.1016/j.annonc.2021.01.068.
23. Herdman M, Gudex C, Lloyd A, et al. Development and preliminary testing of the new five-level version of
EQ-5D(EQ-5D-5L). Qual Life Res 2011;20(10):1727-1736.
24. Investigator’s Brochure: Niraparib/Abiraterone Acetate Fixed-dose Combination, edition 4. Janssen Research
& Development (04 January 2023).
25. Investigator’s Brochure: Niraparib, edition 14. GlaxoSmithKline Research & Development Limited. (21 June
2022).
26. Investigator’s Brochure: ZYTIGA® (abiraterone acetate), edition 17. Janssen Research & Development (17
June 2022).
27. Janssen MF, Pickard AS, Golicki D, et al. Measurement properties of the EQ-5D-5L compared to the EQ-5D-
3L across eight patient groups: a multi-country study. Qual Life Res 2013;22(7):1717-1727.
28. Janssen Research & Development, LLC. A study of niraparib in combination with abiraterone acetate and
prednisone versus abiraterone acetate and prednisone for treatment of participants with metastatic prostate
cancer (MAGNITUDE). Accessed on 31 January 2023. Available at:
https://clinicaltrials.gov/ct2/show/study/NCT03748641
29. Jones P, Altamura S, Boueres J, et al. Discovery of 2-{4-[(3S)-Piperidin-3-yl]phenyl}-2H-indazole-7-
carboxamide (MK-4827): A novel oral poly(ADP-ribose)polymerase (PARP) inhibitor efficacious in BRCA-1
and -2 Mutant Tumors. J Med Chem. 2009;52:7171-7185.
30. Kaelin WG, Jr. The concept of synthetic lethality in the context of anticancer therapy. Nat Rev Cancer.
2005;5(9):689-698.
31. Mallinckrodt C, Lane P. Recommendations for the primary analysis of continuous endpoints in longitudinal
clinical trials. Drug Info J. 2008;42:303-319.
32. Mateo J, Boyson G, Barbieri CE, et al. DNA repair in prostate cancer: biology and clinical implications. Eur
Urol. 2017;71(3):417-425.
33. Maurer W, Bretz F. Multiple testing in group sequential trials using graphical approaches. J Stat Biopharm
Res. 2013;5(4):311-320.
34. Mohler JL, Antonarakis ES, Armstrong AJ et al. NCCN Guidelines, version 2. 2017: Prostate Cancer Updates.
Available at http://www.richclinics.com/upload/201702/28/201702281117291392.pdf. Accessed 14 July 2017.
35. Mottet N, De Santis M, Briers E, et al. Updated guidelines for metastatic hormone-sensitive prostate cancer:
abiraterone acetate combined with castration is another standard. Eur Urology 2018;73:316-321.
36. Na R, Zheng SL, Han M, et al. Germline mutations in ATM and BRCA1/2 distinguish risk for lethal and
indolent prostate cancer and are associated with early age at death. Eur Urol. 2017;17:740-747.
37. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology, v 4.2019.
NCCN August 2019. Accessed on 05 February 2020. Available at:
https://www.nccn.org/professionals/physician_gls/default.aspx#prostate.
38. National Comprehensive Cancer Network. Preliminary recommendations of the NCCN COVID-19
Vaccination Advisory Committee* Version 1.0 1/22/2021. NCCN. 2021. Available at:
https://www.nccn.org/covid-19/pdf/COVID-19_Vaccination_Guidance_V1.0.pdf.
39. Nombela P, Lozano R, Aytes A, Mateo J, Olmos D, Castro E. BRCA2 and other DDR genes in prostate
cancer. Cancers. 2019;11(3):352.
40. O’Donnell A, Judson I, Dowsett M, et al. Hormonal impact of the 17alpha-hydroxylase/C(17,20)-lyase inhibitor
abiraterone acetate (CB7630) in patients with prostate cancer. Br J Cancer. 2004;90(12):2317-2325.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
126
Status: Approved, Date: 28 August 2023
41. Pickard AS, Neary MP, Cella D. Estimation of minimally important differences in EQ-5D utility and VAS
scores in cancer. Health Qual Life Outcomes. 2007 Dec 21;5:70.
42. Rathkopf DE, Smith MR, de Bono JS, et al. Updated interim efficacy analysis and long-term safety of
abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy
(COU-AA-302). Eur Urol. 2014;66(5):815-825.
43. Rodriguez F, Harrison RW, Wojdyla D, Mahaffey KW. Lost to follow-up and withdrawal of consent in
contemporary global cardiovascular randomized clinical trials. Crit Pathways in Cardiol. 2015;14:150-153.
44. Rubin MA, Demichelis F. The genomics of prostate cancer: emerging understanding with technologic
advances. Mod Pathol. 2018;31:S1-S11.
45. Ryan CJ, Smith MR, de Bono JS, et al. Abiraterone in metastatic prostate cancer without previous
chemotherapy. N Engl J Med. 2013;368:138-148.
46. Saad F, Chi KM, Shore N, et al. Phase 1b (BEDIVERE) study of niraparib plus androgen receptor-targeted
therapy (ART) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). Poster presented
at: the 2020 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium. February 13-
15, 2020; San Francisco, CA.
47. Sandhu SK, Schelman WR, Wilding G, et al. The poly (ADP-ribose) polymerase inhibitor niraparib (MK4827)
in BRCA mutation carriers and patients with sporadic cancer: a phase 1 dose-escalation trial. Lancet Oncol.
2013;14(9):882-889.
48. Shahneen Sandhu, Gerhardt Attard, David Olmos, et al. Gene-by-gene analysis in the MAGNITUDE study of
niraparib (NIRA) with abiraterone acetate and prednisone (AAP) in patients (pts) with metastatic castration-
resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations. J Clin
Oncol. 2022; 40(16):5020-5020.
49. Scher HI, Morris MJ, Stadler WM, et al. Trial design and objectives for castration-resistant prostate cancer:
updated recommendations from the prostate cancer clinical trials working group 3. J Clin Oncol.
2016;34(12):1402-1418.
50. Schiewer MJ, Goodwin JF, Han S, et al. Dual roles of PARP-1 promote cancer growth and progression. Cancer
Discov. 2012;2(12):1134-1149.
51. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019;69:7–34.
52. Smith MR, Saad F, Coleman R, et al. Denosumab and bone-metastasis-free survival in men with castration-
resistant prostate cancer: results of a global phase 3, randomised, placebo-controlled trial. Lancet.
2012;379(9810):39-46.
53. Smith MR, Sandhu S, Kelly WK, et al. Pre-specified interim analysis of GALAHAD: A phase 2 study of
niraparib in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA
repair gene defects (DRD). Poster presented at: ESMO 2019 Congress; September 27 - October 1 2019;
Barcelona, Spain.
54. Surveillance, Epidemiology, and End Results (SEER) Program. Cancer stat facts: prostate cancer (2018).
Accessed on 7 February 2020. Available at: https://seer.cancer.gov/statfacts/html/prost.html.
55. Sweeney CJ, Chen Y-H, Carducci M, et al. Chemohormonal therapy in metastatic hormone-sensitive prostate
cancer. N Eng J Med. 2015;373(8):737-746.
56. WHO technical report series 840 (1994): Requirements for the blood collection, processing, and quality control
of blood, blood components, and plasma derivatives. Available at: http://www.who.int/bloodproducts
/publications/WHO_TRS_840_A2.pdf. Accessed 25 March 2020.
57. Wyatt AW, Annala M, Aggarwal R, et al. Concordance of circulating tumor DNA and matched metastatic
tissue biopsy in prostate cancer. J Natl Cancer Inst. 2017;109(12):djx118.
58. ZEJULA® [package insert]. Waltham MA: TESARO, Inc; 2017.
59. ZYTIGA® [package insert]. Horsham, PA: Janssen Biotech, Inc; 2017.

CJNJ-67652000 (niraparib/abiraterone acetate fixed dose combination)
Clinical Protocol 67652000PCR3002 Amendment 4
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
127
Status: Approved, Date: 28 August 2023
INVESTIGATOR AGREEMENT
I have read this protocol and agree that it contains all necessary details for carrying out this study. I will
conduct the study as outlined herein and will complete the study within the time designated.
I will provide copies of the protocol and all pertinent information to all individuals responsible to me who
assist in the conduct of this study. I will discuss this material with them to ensure that they are fully informed
regarding the study treatment, the conduct of the study, and the obligations of confidentiality.
Coordinating Investigator (where required):
Name (typed or printed):
Institution and Address:
Signature: 
Date:
(Day Month Year)
Principal (Site) Investigator:
Name (typed or printed):
Institution and Address:
Telephone Number:
Signature: 
Date:
(Day Month Year)
Sponsor's Responsible Medical Officer:
Name (typed or printed): 
 MD, Executive Medical Director, Oncology
Institution: 
Janssen Research & Development
Signature: [electronic signature appended at the end of the protocol] 
Date:
(Day Month Year)
Note: If the address or telephone number of the investigator changes during the study, written notification will be
provided by the investigator to the sponsor, and a protocol amendment will not be required.
PPD

Signature
User 
Date 
Reason
 
29-Aug-2023
13:45:07
(GMT)
Document Approval
PPD