Clinical trial NCT01517802
Conditions: Metastatic Castration-resistant Prostate Cancer Metastatic Breast Cancer
Keywords: Metastatic castration-resistant prostate cancer Metastatic breast cancer Abiraterone acetate Low-dose corticosteroid treatment Long-term access
Sponsor: Janssen Research & Development, LLC
Start date: 2012-03-28; Completion date: 2021-04-22
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to collect follow-up safety data from participants in completed abiraterone acetate studies for a maximum duration of 9 years.

Detailed description:
This is a nonrandomized (individuals will not be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), long-term safety follow-up study of abiraterone acetate in approximately 300 patients from other completed abiraterone acetate clinical studies. Patients must have received at least 3 months of treatment with abiraterone acetate and a low-dose corticosteroid and, based on investigator assessment, may benefit from continued treatment. This study will consist of a screening period followed by open-label treatment of continued abiraterone acetate access. The patients will continue with the same abiraterone acetate and low-dose corticosteroid dosing regimen they were receiving in the previous abiraterone acetate clinical study until the investigator determines that the patient is no longer receiving benefit or the sponsor terminates the study. Patients can be withdrawn from the study if an alternative access (eg, patient-assistance program or commercial source of abiraterone acetate) is available and feasible. Each cycle of treatment will be 28 days. Investigators will monitor and assess the patients for response to treatment or progression according to routine practice or as clinically indicated to determine whether continued treatment with abiraterone acetate is warranted. No efficacy data are being collected. Safety will be monitored throughout the study for a maximum duration of 9 years. End-of-study assessments will be performed at least 30 days after the last dose of abiraterone or upon early withdrawal.

Arms: arm 1: Patients will continue the same treatment regimen they were receiving during their participation in the previous abiraterone acetate clinical study.
Interventions: intervention 1: Abiraterone acetate intervention 2: Prednisone
Intervention descriptions: intervention 1: Type=exact number, unit=mg, number=1000, form=tablet, route=oral, abiraterone acetate once daily intervention 2: Type=exact number, unit=mg, number=5, form=tablet, route=oral, prednisone or prednisolone twice daily

Protocol documents:
Prot_SAP_000.pdf: 
Approved: 11 March 2015
1
Janssen Research & Development*
Clinical Protocol
A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Safety Study
Protocol 212082PCR3010; Phase 3b
JNJ-212082 (abiraterone acetate)
Amendment INT-2
*Janssen Research & Development is a global organization that operates through different legal entities in
various countries. 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; 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.
Only sites in the United States (U.S.) will conduct this study under U.S. Food & Drug 
Administration (FDA) IND regulations (21 Code of Federal Regulations [CFR] Part 312).
EudraCT NUMBER:  2011-005243-28
Issue/Report Date:
11 March 2015
Prepared by:
Janssen Research & Development, LLC
Document No.:
EDMS-ERI-29599689:5.0
Compliance: This study will be conducted in compliance with this protocol, Good Clinical Practice, and applicable regulatory 
requirements.
Confidentiality Statement
The information in this document contains trade secrets and commercial information that are privileged or confidential and may 
not be disclosed unless such disclosure is required by applicable law or regulations. In any event, persons to whom the 
information is disclosed must be informed that the information is privileged or confidential and may not be further disclosed by 
them. These restrictions on disclosure will apply equally to all future information supplied to you that is indicated as privileged
or confidential.
NCT01517802


JNJ-212082 (abiraterone acetate)
Clinical Protocol 212082PCR3010 – Amendment INT-2
Approved: 11 March 2015
2
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 drug, 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)
PPD
PPD


JNJ-212082 (abiraterone acetate)
Clinical Protocol 212082PCR3010 – Amendment INT-2
Approved: 11 March 2015
3
TABLE OF CONTENTS
INVESTIGATOR AGREEMENT ................................................................................................................... 2
TABLE OF CONTENTS ............................................................................................................................... 3
LIST OF IN-TEXT TABLES.......................................................................................................................... 4
PROTOCOL AMENDMENTS....................................................................................................................... 5
SYNOPSIS.................................................................................................................................................... 8
SUGGESTED TIME AND EVENTS SCHEDULE....................................................................................... 10
ABBREVIATIONS ...................................................................................................................................... 11
1.
INTRODUCTION................................................................................................................................ 12
1.1.
Overall Rationale for the Study...................................................................................................... 12
2.
OBJECTIVE AND HYPOTHESIS...................................................................................................... 12
2.1.
Objective ........................................................................................................................................ 12
2.2.
Hypothesis ..................................................................................................................................... 12
3.
STUDY DESIGN AND RATIONALE ................................................................................................. 12
3.1.
Overview of Study Design.............................................................................................................. 13
3.2.
Rationale for Study Design ............................................................................................................ 13
4.
SUBJECT POPULATION.................................................................................................................. 14
4.1.
Inclusion Criteria ............................................................................................................................ 14
4.2.
Exclusion Criteria ........................................................................................................................... 14
4.3.
Prohibitions and Restrictions ......................................................................................................... 14
5.
TREATMENT ALLOCATION AND BLINDING................................................................................. 15
6.
DOSAGE AND ADMINISTRATION .................................................................................................. 15
6.1.
Dose Modification and Management of Adverse Events ............................................................... 15
6.1.1.
Management of Hypokalemia.................................................................................................. 16
6.1.2.
Management of Hypertension ................................................................................................. 16
6.1.3.
Management of Edema and Fluid Retention........................................................................... 17
6.1.4.
Management of Abnormal Liver Function Tests...................................................................... 17
6.1.5.
Management of Non-Mineralocorticoid Side Effects ............................................................... 18
7.
TREATMENT COMPLIANCE............................................................................................................ 19
8.
CONCOMITANT THERAPY.............................................................................................................. 19
8.1.
Potential for Drug-Drug Interactions ........................................................................................... 19
9.
STUDY EVALUATIONS .................................................................................................................... 20
9.1.
Study Procedures........................................................................................................................... 20
9.1.1.
Overview..................................................................................................................................... 20
9.1.1.1.
Screening and Treatment Phase............................................................................................. 20
9.1.1.2.
End-of-Treatment Visit............................................................................................................. 20
9.2.
Efficacy Evaluations....................................................................................................................... 20
9.3.
Safety Evaluations ......................................................................................................................... 20
10.
SUBJECT COMPLETION/WITHDRAWAL....................................................................................... 21
10.1.
Completion ..................................................................................................................................... 21
10.2.
Withdrawal From the Study............................................................................................................ 21
11.
STATISTICAL METHODS................................................................................................................. 21


JNJ-212082 (abiraterone acetate)
Clinical Protocol 212082PCR3010 – Amendment INT-2
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11.1.
Sample Size Determination ........................................................................................................... 21
12.
ADVERSE EVENT REPORTING ...................................................................................................... 21
12.1.
Definitions ...................................................................................................................................... 22
12.1.1.
Adverse Event Definitions and Classifications ........................................................................... 22
12.1.2.
Attribution Definitions.................................................................................................................. 23
12.1.3.
Severity Criteria ....................................................................................................................... 23
12.2.
Special Reporting Situations.......................................................................................................... 24
12.3.
Procedures..................................................................................................................................... 24
12.3.1.
All Adverse Events...................................................................................................................... 24
12.3.2.
Serious Adverse Events ............................................................................................................. 25
12.4.
Contacting Sponsor Regarding Safety........................................................................................... 26
13.
PRODUCT QUALITY COMPLAINT HANDLING.............................................................................. 26
13.1.
Procedures..................................................................................................................................... 26
13.2.
Contacting Sponsor Regarding Product Quality ............................................................................ 27
14.
STUDY DRUG INFORMATION......................................................................................................... 27
14.1.
Physical Description of Study Drug(s) ........................................................................................... 27
14.2.
Packaging ...................................................................................................................................... 27
14.3.
Labeling.......................................................................................................................................... 27
14.4.
Preparation, Handling, and Storage............................................................................................... 27
14.5.
Drug Accountability ........................................................................................................................ 27
15.
STUDY-SPECIFIC MATERIALS....................................................................................................... 28
16.
ETHICAL ASPECTS ......................................................................................................................... 28
16.1.
Study-Specific Design Considerations........................................................................................... 28
16.2.
Regulatory Ethics Compliance....................................................................................................... 29
16.2.1.
Investigator Responsibilities ....................................................................................................... 29
16.2.2.
Independent Ethics Committee or Institutional Review Board ................................................... 29
16.2.3.
Informed Consent ....................................................................................................................... 30
16.2.4.
Privacy of Personal Data ............................................................................................................ 31
16.2.5.
Country Selection ....................................................................................................................... 32
17.
ADMINISTRATIVE REQUIREMENTS .............................................................................................. 32
17.1.
Protocol Amendments.................................................................................................................... 32
17.2.
Regulatory Documentation ............................................................................................................ 32
17.2.1.
Regulatory Approval/Notification ................................................................................................ 32
17.2.2.
Required Prestudy Documentation............................................................................................. 32
17.3.
Subject Identification, Enrollment, and Screening Logs ................................................................ 33
17.4.
Source Documentation................................................................................................................... 34
17.5.
Case Report Form Completion ...................................................................................................... 34
17.6.
Data Quality Assurance/Quality Control ........................................................................................ 34
17.7.
Record Retention ........................................................................................................................... 34
17.8.
Monitoring ...................................................................................................................................... 35
17.9.
Study Completion/Termination....................................................................................................... 35
17.9.1.
Study Completion ....................................................................................................................... 35
17.9.2.
Study Termination....................................................................................................................... 35
17.10.
On-Site Audits ................................................................................................................................ 36
17.11.
Use of Information and Publication................................................................................................ 36
REFERENCES............................................................................................................................................ 38
LAST PAGE................................................................................................................................................ 38
LIST OF IN-TEXT TABLES 
Table 1:
Hypokalemia Management ....................................................................................................... 16


JNJ-212082 (abiraterone acetate)
Clinical Protocol 212082PCR3010 – Amendment INT-2
Approved: 11 March 2015
5
PROTOCOL AMENDMENTS
Protocol Version 
Issue Date
Original Protocol
30 November 2011
Amendment INT-1
9 April 2012
Amendment INT-2
11 March 2015
Amendments are listed beginning with the most recent amendment.
Amendment INT-2 (11 March 2015)
This amendment is considered to be substantial based on the criteria set forth in Article 10(a) of Directive 
2001/20/EC of the European Parliament and the Council of the European Union.
The overall reason for the amendment: The overall reason for the amendment is to extend the period for long-
term safety follow up.
Applicable Section(s)
Description of Change(s)
Rationale: Specified that follow-up for safety will continue for a maximum duration of  6 years from the protocol 
INT-1 issue date (9 April 2012)
Synopsis Rationale, 
Objective, Overview;
1.1 Rationale;
2.1. Objective;
3.1. Overview;
3.2 Rationale;
9.1.1.2. End-of-
Treatment Visit;
10.1. Completion;
16.1. Design 
Considerations
Updated follow-up for safety to a maximum duration of 6 years from the protocol INT-1 
issue date (9 April 2012). 
Rationale: To provide updated drug-drug interaction information for CYP3A4
Section 8.1 Drug-Drug 
Interaction
Text updated to include current CYP3A4 drug-drug interaction information
Rationale: To comply with current internal standards for protocol development
Throughout the 
protocol
Mandatory protocol text was updated
Rationale: Minor errors were noted
Throughout the 
protocol
Minor grammatical, formatting, or spelling changes were made.


JNJ-212082 (abiraterone acetate)
Clinical Protocol 212082PCR3010 – Amendment INT-2
Approved: 11 March 2015
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Amendment INT-1 (9 April 2012)
This amendment is considered to be substantial based on the criteria set forth in Article 10(a) of Directive 
2001/20/EC of the European Parliament and the Council of the European Union.
The overall reason for the amendment: The overall reason for the amendment is to add long-term safety data 
collection in this study.
Applicable Section(s)
Description of Change(s)
Rationale: Changed this study from a long-term access study to a long-term safety follow-up study, per Medicines 
and Healthcare products Regulatory Agency (MHRA) request.
Title page;
Synopsis Protocol 
Title
Replaced the word “access” with the word “safety” in the protocol title.
Synopsis Rationale, 
Objective, 
Hypothesis, 
Overview;
1.1 Rationale;
2.1. Objective;
2.2. Hypothesis;
3. Design and
Rationale;
3.1. Overview;
3.2 Rationale;
16.1. Design
Considerations
Specified that this is a long-term safety follow-up study.
Rationale: Specified that follow-up for safety will continue for a maximum duration of 3 years from the protocol 
issue date of 9 April 2012, per MHRA request.
Synopsis Rationale, 
Objective, Overview;
1.1 Rationale;
2.1. Objective;
3.1. Overview;
3.2 Rationale;
9.1.1.2. End-of-
Treatment Visit;
10.1. Completion;
16.1. Design 
Considerations
Updated follow-up for safety to a maximum of 3 years from the protocol issue date of 
9 April 2012. 
Rationale: To allow for potential extension of study duration following review of the safety data at 3 years.
Synopsis Rationale, 
Overview;
1.1 Rationale;
3.1. Overview;
3.2 Rationale;
9.1.1.2. End-of-
Treatment Visit;
10.1. Completion;
16.1. Design 
Considerations
Added statement that consideration will be given to extend the study duration following 
review of the safety data at 3 years.


JNJ-212082 (abiraterone acetate)
Clinical Protocol 212082PCR3010 – Amendment INT-2
Approved: 11 March 2015
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Applicable Section(s)
Description of Change(s)
Rationale: To ensure subject’s anonymity.
17.3. Subject 
Identification
Indicated that subject will be identified by subject ID and date of birth instead of the 
assigned number.
Rationale: To comply with current standards for safety reporting.
16.2.2. IEC/IRB
Replaced “Annual Safety Reports” with “Development Safety Update Report.”
Rationale: To comply with current internal standards for the company name (new legal entity).
Title page;
Investigator Signature 
Page
Replaced with Janssen Research & Development, LLC.
Rationale: Minor errors were noted
Throughout the 
protocol
Minor grammatical, formatting, or spelling changes were made.


JNJ-212082 (abiraterone acetate)
Clinical Protocol 212082PCR3010 – Amendment INT-2
Approved: 11 March 2015
8
SYNOPSIS
A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Safety Study
Abiraterone [17-(3-pyridyl) androsta-5, 16-dien-3β-ol] is an irreversible inhibitor of CYP17 
(17α-hydroxylase/C17, 20-lyase), a dual function enzyme that catalyzes 2 critical reactions in the 
synthesis of testosterone. Abiraterone acetate is the prodrug of the active drug abiraterone. Abiraterone 
acetate has received marketing approval in the United States, European Union, Canada, Brazil, and 
Switzerland for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) after 
docetaxel treatment. It is being investigated for the treatment of mCRPC in men who have not previously 
received chemotherapy for mCRPC and in women with metastatic breast cancer.
The rationale for this study is to collect follow-up safety data from subjects in completed abiraterone 
acetate studies (eg, studies in which the final analysis of the primary endpoint has been performed) for a 
maximum duration of 6 years from the protocol INT-1 issue date (9 April 2012).
OBJECTIVE AND HYPOTHESIS
Objective
To collect long term follow-up safety data from subjects in completed abiraterone acetate studies for a 
maximum duration of 6 years from the protocol INT-1 issue date (9 April 2012).
Hypothesis
This is an open-label uncontrolled long-term safety follow-up study to provide continued abiraterone 
acetate access to subjects who are receiving treatment in an abiraterone acetate clinical study at the time 
the study is considered complete. No hypothesis is being tested.
OVERVIEW OF STUDY DESIGN
This Phase 3b multicenter, open-label study is designed to collect long-term follow-up safety data from 
subjects in completed abiraterone acetate studies for a maximum duration of 6 years from the protocol 
INT-1 issue date (9 April 2012).The subjects will continue with the same abiraterone acetate and low
dose corticosteroid regimen they were receiving in the previous abiraterone acetate clinical study until the 
investigator determines that the subject is not receiving benefit from continued treatment, the study is
terminated by the sponsor or for other reasons as defined in the protocol. Subjects can be withdrawn from 
the study if an alternative access (eg, patient-assistance program or commercial source of abiraterone 
acetate) is available and feasible.
Subjects will sign the informed consent and be screened for eligibility during the Screening Phase. 
Eligibility in this study requires that subjects would have already received at least 3 months (3 cycles) of 
treatment. During the Treatment Phase, abiraterone acetate should be taken each day at least 2 hours after 
eating and no food should be eaten for at least 1 hour after taking abiraterone acetate. All subjects will 
also take a low dose corticosteroid (eg, 5 mg of prednisone or prednisolone orally twice daily); it is not 
required for the low dose corticosteroid to be taken at the same time as abiraterone acetate. For 
consistency, at the first dose of study medication all subjects will restart cycle count as Cycle 1, Day 1. 
Each cycle of treatment will be 28 days.
Investigators should monitor and assess the subjects for response to treatment or progression according to 
routine practice. Suggested timing and assessments are outlined in the Time and Events Schedule. The 
timing of assessments may be modified if clinically indicated or based on local label requirements. No 
efficacy data are being collected by the sponsor. Any serious adverse event should be reported to the 
sponsor by investigational staff within 24 hours of their knowledge of the event as outlined in the 
protocol. No other safety data are being collected by the sponsor. 


JNJ-212082 (abiraterone acetate)
Clinical Protocol 212082PCR3010 – Amendment INT-2
Approved: 11 March 2015
9
SUBJECT POPULATION
The subjects enrolled in this study are participating in an abiraterone acetate clinical study that is now 
considered complete and will have received at least 3 months of abiraterone acetate and low dose 
corticosteroid treatment. Eligibility criteria also include the investigator's assessment that continued 
abiraterone acetate therapy may provide clinical benefit. The subjects should not have laboratory
evaluations or medical conditions that would preclude them from continuing to receive abiraterone 
acetate.
DOSAGE AND ADMINISTRATION
Abiraterone acetate and low dose corticosteroids will be given orally as tablets according to the regimen
established in the prior abiraterone acetate clinical study (eg, abiraterone acetate 1,000 mg [4 tablets] once 
daily without food with prednisone 5 mg orally twice daily). Lower doses of abiraterone acetate (500 mg 
or 750 mg daily) and lower doses of corticosteroids are permitted per the regimen established in the prior
study. Study treatment will continue until the investigator determines the subject is no longer receiving 
benefit from continued treatment, or other reasons as described in the protocol.
EFFICACY EVALUATIONS
Investigators should monitor and assess the subjects for response to treatment or progression according to 
routine practice to determine whether continued treatment with abiraterone acetate is warranted.
Suggested timing and assessments are outlined in the Time and Events Schedule. All assessments and 
evaluations should be documented in the source medical record. No efficacy data will be collected and 
analyzed by the sponsor.
SAFETY EVALUATIONS
Vital signs, physical examinations, clinical laboratory tests, and adverse events should be monitored and 
evaluated by the investigator according to routine practice. Suggested timing and assessments are outlined
in the Time and Events Schedule. The timing of assessments may be modified if clinically indicated or 
based on local label requirements. All safety evaluations and adverse events should be documented in the 
source medical record.
Any serious adverse event occurring during the study must be reported to the sponsor by investigational 
staff within 24 hours of their knowledge of the event. The sponsor will only collect serious adverse events
by the serious adverse event reporting process outlined in the protocol. No other safety data will be 
collected and analyzed by the sponsor.
STATISTICAL METHODS
The sample size for this study is not powered according to statistical calculation. It is estimated that 
approximately 300 subjects may participate in this study. The number of subjects enrolled will depend on 
the number of subjects from other abiraterone acetate studies who are receiving treatment at the time that 
a study is considered complete. No efficacy analyses are planned for this study.


JNJ-212082 (abiraterone acetate)
Clinical Protocol 212082PCR3010 – Amendment INT-2
Approved: 11 March 2015
10
SUGGESTED TIME AND EVENTS SCHEDULE
Phase 3b
Treatment Phase
Screening Phase
Cycle 1a
Every Third 
Cycle Until 
Treatment 
Discontinuation
End-of-Treatment 
Visit
Day -30 to -1
Day 1
Day 1
Study Procedures
Informed consent
X
Inclusion/exclusion criteria
X
Hematology
Xb
Xc
Serum chemistry, electrolytes, LFTs
Xb
Xc
Dispense/administer study drug 
X
X
Drug accountability
X
Tumor assessment/PSA response
Xd
Physical examination
X
X
Vital signs
X
X
Concomitant therapy
X
X
Adverse eventse
X
X
X
X
LFT=liver function test; PSA=prostate-specific antigen
aWhile the subjects enrolling in this study would have already received at least 3 months (3 cycles) of treatment, for 
consistency, all subjects will restart cycle count at Cycle 1, Day 1.
bUse laboratory assessments from the last visit in the previous abiraterone acetate study if the visit occurred 30 days 
or less from Cycle 1, Day 1.
cThe suggested timing of laboratory assessments may be more frequent as clinically indicated or modified to meet 
local label requirements.
dTumor assessment/PSA response evaluations are to be performed at the discretion of the investigator based on 
routine treatment or as clinically indicated.
eSerious adverse events should be reported to the sponsor by investigational staff within 24 hours of their knowledge 
of the event using the instructions provided with the Serious Adverse Event Form. An End-of-Treatment Visit (or 
phone call) for a safety assessment should take place at least 30 days after the last dose of study medication.  


JNJ-212082 (abiraterone acetate)
Clinical Protocol 212082PCR3010 – Amendment INT-2
Approved: 11 March 2015
11
ABBREVIATIONS
ACTH
adrenocorticotropic hormone
ALT 
alanine aminotransferase
AST
aspartate aminotransferase
CTCAE
Common Terminology Criteria for Adverse Events
CYP
cytochrome 
GCP
Good Clinical Practice
ICH
International Conference on Harmonisation
IEC
Independent Ethics Committee
IRB
Institutional Review Board
mCRPC
metastatic castration-resistant prostate cancer
NCI
National Cancer Institute
PQC
Product Quality Complaint
SUSAR
suspected unexpected serious adverse reaction
ULN
upper limit of normal


JNJ-212082 (abiraterone acetate)
Clinical Protocol 212082PCR3010 – Amendment INT-2
Approved: 11 March 2015
12
1.
INTRODUCTION
Abiraterone [17-(3-pyridyl) androsta-5, 16-dien-3β-ol] is an irreversible inhibitor of CYP17 
(17α-hydroxylase/C17,20-lyase), a dual function enzyme that catalyzes 2 critical reactions in the 
synthesis of testosterone. Abiraterone acetate is the prodrug of the active drug abiraterone.
Abiraterone acetate has received marketing approval in the United States, European Union,
Brazil, Switzerland, and Canada for the treatment of men with metastatic castration-resistant 
prostate cancer (mCRPC) after docetaxel treatment. It is being investigated for the treatment of 
mCRPC in men who have not previously received chemotherapy for mCRPC and in women with 
metastatic breast cancer.
For the most comprehensive nonclinical and clinical information regarding the efficacy and 
safety of abiraterone acetate, refer to the latest version of the Investigator's Brochure for 
abiraterone acetate.1
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.
1.1.
Overall Rationale for the Study
The rationale for this study is to collect follow-up safety data from subjects in completed 
abiraterone acetate studies (eg, studies in which the final analysis of the primary endpoint has 
been performed) for a maximum duration of 6 years from the protocol INT-1 issue date (9 April 
2012). The early Phase 1 and 2 studies have only a few subjects continuing to receive treatment. 
Moving these subjects and the subjects from completed Phase 3 studies to a single access study 
improves coordination of the management of these subjects. 
2.
OBJECTIVE AND HYPOTHESIS
2.1.
Objective
To collect long term follow-up safety data from subjects in completed abiraterone acetate studies 
for a maximum duration of 6 years from the protocol INT-1 issue date (9 April 2012).
2.2.
Hypothesis
This is an open-label uncontrolled long-term safety follow-up study to provide continued 
abiraterone acetate access to subjects who are receiving treatment in an abiraterone acetate 
clinical study at the time the study is considered complete. No hypothesis is being tested.
3.
STUDY DESIGN AND RATIONALE
This is a Phase 3b, multicenter, open-label, long-term safety follow-up study. Approximately 
300 subjects from other abiraterone acetate clinical studies will participate in this study. Subjects 
must have received at least 3 months of treatment with abiraterone acetate and low dose 
corticosteroid (eg, prednisone or prednisolone) and, based on investigator assessment, may
benefit from continued treatment.


JNJ-212082 (abiraterone acetate)
Clinical Protocol 212082PCR3010 – Amendment INT-2
Approved: 11 March 2015
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3.1.
Overview of Study Design
This study is designed to collect long-term follow-up safety data from subjects who received at 
least 3 months of abiraterone acetate treatment in completed abiraterone acetate studies and are 
still deriving benefit from continued treatment based on investigator assessment. Follow-up for 
safety in this study will continue for a maximum duration of 6 years from the protocol INT-1 
issue date (9 April 2012). The subjects will continue with the same abiraterone acetate and low 
dose corticosteroid dosing regimen they were receiving in the previous abiraterone acetate 
clinical study until the investigator determines that the subject is no longer receiving benefit, the 
sponsor terminates the study, or for other reasons as defined in Section 10. Subjects can be 
withdrawn from the study if an alternative access (eg, patient-assistance program or commercial
source of abiraterone acetate) is available and feasible.
Subjects will sign the informed consent and be screened for eligibility during the Screening 
Phase. Subjects enrolling in this study would have received at least 3 months (3 cycles) of 
treatment. During the Treatment Phase, abiraterone acetate should be taken each day at least 
2 hours after eating and no food should be eaten for at least 1 hour after taking abiraterone 
acetate. All subjects will also take a low dose corticosteroid (eg, 5 mg of prednisone or 
prednisolone orally twice daily); it is not required for the low dose corticosteroid to be taken at 
the same time as abiraterone acetate. For consistency, all subjects will restart cycle count as
Cycle 1, Day 1. Each cycle of treatment will be 28 days.
Suggested timing and assessments are outlined in the Time and Events Schedule. While the 
protocol has recommendations, the timing of assessments is at the discretion of the investigator 
as clinically indicated or modified to meet local label requirements. Investigators should monitor 
and assess the subjects for response to treatment or progression according to routine practice or 
as clinically indicated to determine whether continued treatment with abiraterone acetate is 
warranted. No efficacy data are being collected by the sponsor. Serious adverse events should be 
reported to the sponsor by investigational staff within 24 hours of their knowledge of the event 
using instructions provided in the Serious Adverse Event Report Form (see Section 12.3.2). No 
other safety data will be collected and analyzed by the sponsor. An End-of-Treatment Visit or 
phone call for a safety assessment should take place at least 30 days after the last dose of 
abiraterone acetate.
3.2.
Rationale for Study Design
This long-term safety study was designed to collect follow-up safety data from subjects in 
completed abiraterone acetate studies for a maximum duration of 6 years from the protocol 
INT-1 issue date (9 April 2012). The sponsor recommends tumor assessments to take place every 
3 months as was done after 4 cycles of treatment in the Phase 3 studies. For laboratory 
evaluations, the sponsor also recommends evaluations at least every 3 months unless more 
frequent evaluations are required per the local label. The dispensing of study medication and 
drug accountability also occur every 3 months, thus making it more convenient for the subject.
End of study definition: The study is considered completed with the last End-of-Treatment 
safety assessment for the last subject participating in the study (maximum study duration of 6 


JNJ-212082 (abiraterone acetate)
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years from the protocol INT-1 issue date of 9 April 2012) or upon a decision by the sponsor to 
terminate the study.
4.
SUBJECT POPULATION
The inclusion and exclusion criteria for enrolling subjects in this study are described in the 
following 2 subsections. If there is a question about the inclusion or exclusion criteria below, the 
investigator should consult with the appropriate sponsor representative before enrolling a subject 
in the study. 
4.1.
Inclusion Criteria
Each potential subject must satisfy all of the following criteria to be enrolled in the study.
1.
Currently participating in an abiraterone acetate clinical study considered complete and 
had received at least 3 months of treatment with abiraterone acetate tablets
2.
Investigator’s assessment that continued abiraterone acetate therapy will be safe and 
beneficial
3.
If a man is sexually active with a woman of childbearing potential (eg, premenarchal, 
non-postmenopausal), he must agree to use a double barrier method of birth control and 
to not donate sperm during the study and for 3 months after receiving the last dose of 
study drug
4.
Sign an informed consent document indicating that they understand the purpose of and 
procedures required for the study and are willing to participate in the study
4.2.
Exclusion Criteria
Any potential subject who meets any of the following criteria will be excluded from participating 
in the study.
1.
Medical conditions that require hospitalization
2.
Any condition or situation which, in the opinion of the investigator, may put the subject 
at significant risk, may confound the study results, or may interfere significantly with 
subject’s participation in the study
4.3.
Prohibitions and Restrictions 
Subjects must be willing and able to adhere to the following prohibitions and restrictions during 
the course of the study to be eligible for participation:

If a man is sexually active with a woman of childbearing potential (eg, premenarchal, 
non-postmenopausal), he must use a double barrier method of birth control and not donate 
sperm during the study and for 3 months after receiving the last dose of study drug.


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
Treatment restrictions outlined in Section 8.
5.
TREATMENT ALLOCATION AND BLINDING
This is an open-label study; subjects will continue the same treatment regimen they were 
receiving during their participation in the previous abiraterone acetate clinical study.
6.
DOSAGE AND ADMINISTRATION
Abiraterone acetate will be given orally as tablets once daily continuously according to the 
regimen established in the previous abiraterone acetate clinical study (eg, abiraterone acetate 
1,000 mg taken as four 250-mg tablets). Abiraterone acetate should be taken at least 2 hours after 
eating. Also, no food should be eaten for at least 1 hour after taking the dose. Lower doses of 
abiraterone acetate (500 mg or 750 mg daily) are permitted per the regimen established for a 
subject in the previous study. Each cycle consists of 28 days. Sufficient study drug for 3 cycles 
will be dispensed and taken outside the clinic. A missed dose of abiraterone acetate should be 
omitted and not made up. Study treatment will continue until the investigator decides the subject 
is no longer receiving benefit from continued treatment or other reasons as defined in Section 10.
Prednisone or prednisolone (5 mg tablet twice daily) or other corticosteroid need not be taken at 
the same time as abiraterone acetate. Lower doses of corticosteroids are permitted per the 
regimen established for the subject in the previous study. A change in the dose of abiraterone 
acetate does not necessarily warrant a change in the dose of corticosteroid. If a corticosteroid
dose is missed, it should be omitted and will not be made up.
Study staff will instruct subjects on how to store medication for at-home use as indicated for this 
protocol (see Section 14). 
6.1.
Dose Modification and Management of Adverse Events
In clinical studies, abiraterone acetate was generally well tolerated. The most common 
abiraterone acetate-related adverse events included fatigue (cortisol reduced by CYP17 
inhibition) and mineralocorticoid-related hypertension, fluid retention, and hypokalemia 
(compensatory adrenocorticotropic hormone [ACTH] drive). Low dose prednisone/prednisolone
or other glucocorticoids are expected to mitigate these effects through cortisol supplementation 
and abrogation of the ACTH drive. 
For the management of adverse events known to be associated with abiraterone acetate treatment 
follow the local label instructions. In areas where abiraterone acetate does not yet have 
marketing authorization, follow the management guidelines outlined in Sections 6.1.1 through 
6.15 (as applicable). 
Adverse events may be related to progressing prostate cancer. Therefore, investigators are 
strongly encouraged to use approaches other than dose reduction to address adverse events. Up 
to 2 dose reductions are allowed for adverse events if the dose at the time of the adverse event 
was the full dose (ie, 1,000 mg [4 tablets]); doses of abiraterone acetate lower than 500 mg/day 
(2 tablets) are not allowed. At each dose reduction the dose will be reduced by 1 tablet, eg, 
4 tablets (1,000 mg) to 3 tablets (750 mg), and 3 tablets (750 mg) to 2 tablets (500 mg). After an 


JNJ-212082 (abiraterone acetate)
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abiraterone acetate dose reduction, the abiraterone acetate dose should not be increased without 
documentation of adverse event resolution. If interruption of abiraterone acetate is required, 
dosing should not be resumed until resolution of the adverse event is documented.
Subjects receive low-dose prednisone/prednisolone (or other corticosteroid) taken with 
abiraterone acetate. Following prolonged glucocorticoid therapy, subjects may develop 
Cushing’s syndrome, characterized by central obesity, thin skin, easy bruising, bone loss, 
avascular necrosis of the hip, cataracts, and proximal myopathy. With long-term glucocorticoid 
therapy, a rapid withdrawal may result in symptoms that include fever, myalgia, fatigue, 
arthralgia, and malaise, which may occur even without evidence of obvious adrenal 
insufficiency.
6.1.1.
Management of Hypokalemia
Subjects who experience hypokalemia should be managed as presented in Table 1.
Table 1: Hypokalemia Management
6.1.2.
Management of Hypertension

If Grade 1 or 2 adverse events occur, supportive management per investigator. No 
abiraterone acetate dose reduction.

If Grade 3 or 4 adverse events occur, withhold abiraterone acetate. Adjust or add 
medications to mitigate the toxicity or consider the specific mineralocorticoid receptor 
blocker, eplerenone. When toxicity resolves to Grade 1, resume abiraterone acetate at the 
previous dose. 

If toxicity recurs, withhold abiraterone acetate, and adjust or add medications to mitigate the 
toxicity. When toxicity resolves to Grade 1, resume abiraterone acetate at with the first 
dose level reduction (eg, if 1,000 mg [4 tablets] adjust to 750 mg [3 tablets] if at 750 mg 
[3 tablets] adjust to 500 mg [2 tablets]).
Serum 
Potassium
Grade of 
Hypokalemia
Action
Further Action
or Maintenance
Low K+ or 
history of 
hypokalemia
At least weekly laboratory 
electrolyte evaluations
Titrate potassium supplement
dose to serum K+ 3.5 to 
5.0 mM; maintenance at 
4.0 mM is recommended.
<3.5 to 3.0 mM
Grade 1 to 2
Initiate oral K+ supplementation
Titrate potassium supplement
dose to serum K+ 3.5 to 
5.0 mM; maintenance at 
4.0 mM is recommended.
<3.0 to 2.5 mM
Grade 3
Withhold abiraterone acetate 
and initiate IV K+ and cardiac 
monitoring
Recommended to discuss 
reinitiation of abiraterone 
acetate with the medical 
monitor.
<2.5 mM
Grade 4
Withhold abiraterone acetate 
and initiate IV K+ and cardiac 
monitoring
Recommended to discuss 
reinitiation of abiraterone 
acetate with the medical 
monitor.


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
If toxicity recurs, withhold abiraterone acetate, and adjust or add medications to mitigate the 
toxicity. When toxicity resolves to Grade 1, resume study drug with the second dose level 
reduction (2 tablets, 500 mg of study drug) unless the dose was already at 500 mg 
(2 tablets), in this case discontinue abiraterone acetate. 

If toxicity recurs despite optimal medical management and at a dose of 500 mg (2 tablets), 
then discontinue abiraterone acetate. 
6.1.3.
Management of Edema and Fluid Retention

If pedal edema occurs, supportive management per investigator. No abiraterone acetate dose 
reduction.

If anasarca or pulmonary edema requiring supplemental oxygen occurs withhold abiraterone 
acetate. Adjust or add medications to mitigate the toxicity or consider the specific 
mineralocorticoid receptor blocker, eplerenone. When toxicity resolves to Grade 1, resume 
abiraterone acetate at the previous dose. 

If toxicity recurs, withhold abiraterone acetate and adjust or add medications to mitigate the 
toxicity. When toxicity resolves to Grade 1, resume abiraterone acetate with the first dose 
level reduction (eg, if 1,000 mg [4 tablets] adjust to 750 mg [3 tablets] or if at 750 mg 
[3 tablets] adjust to 500 mg [2 tablets]).

If toxicity recurs, withhold study drug, and adjust or add medications to mitigate the 
toxicity. When toxicity resolves to Grade 1, resume study drug with the second dose level 
reduction (2 tablets, 500 mg of study drug) unless the dose was already at 500 mg 
(2 tablets), in this case discontinue abiraterone acetate.

If toxicity recurs despite optimal medical management and at a dose of 500 mg (2 tablets), 
then discontinue abiraterone acetate. 
6.1.4.
Management of Abnormal Liver Function Tests

If Grade 1 increases in aspartate aminotransferase (AST), alanine aminotransferase (ALT) or 
bilirubin occur (eg, increase in AST or ALT from ULN to 2.5X Upper limit of normal 
(ULN); increase in total bilirubin from ULN to 1.5X ULN): The frequency of liver function 
test monitoring should be increased, if the investigator assesses that the laboratory 
abnormalities are potentially related to abiraterone acetate. No abiraterone acetate dose 
reduction is required. 

If Grade 2 increases in AST, ALT or bilirubin occur (eg, increase in AST or ALT to 
>2.5-5X ULN; increase in total bilirubin from >1.5-3X ULN): The frequency of liver 
function test monitoring should be increased to once a week or more, if the investigator 
assesses that the laboratory abnormalities are potentially related to abiraterone acetate. No
abiraterone acetate dose reduction is required. 

If Grade 3 increases in AST, ALT, or bilirubin occur (eg, increase in AST or ALT to 
>5X-20X ULN; increase in total bilirubin to >3X-10X ULN), withhold abiraterone acetate 
and all other concomitant medications that are potentially hepatotoxic. Frequent laboratory 
evaluations (at least once weekly) should be conducted until the liver function tests return to 
≤Grade 1 or baseline. Liver enzyme measurements should be made immediately, regardless 
of when the next study visit or monitoring interval is scheduled.


JNJ-212082 (abiraterone acetate)
Clinical Protocol 212082PCR3010 – Amendment INT-2
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
If study abiraterone acetate resumption is considered for subjects who have experienced 
Grade 3 increases in AST, ALT, or bilirubin, then resume abiraterone acetate with first 
dose level reduction (eg, if 1,000 mg [4 tablets] adjust to 750 mg [3 tablets] or if at 
750 mg [3 tablets] adjust to 500 mg [2 tablets]) when Grade 3 toxicities resolve to 
≤Grade 1 or baseline value.

If Grade 3 increases in AST, ALT, or bilirubin recur after the first dose reduction, 
withhold abiraterone acetate and all other concomitant medications that are potentially 
hepatotoxic. Frequent laboratory evaluations should be conducted (at minimum weekly) 
until the liver function tests return to ≤Grade 1 or baseline value. Liver enzyme 
measurements should be made immediately, regardless of when the next study visit or 
monitoring interval is scheduled.

If abiraterone acetate resumption is considered for subjects who have experienced 
Grade 3 increases in AST, ALT, or bilirubin with the first dose reduction, resume 
abiraterone acetate with the second dose level reduction (500 mg, 2 tablets) unless the 
dose was already at 500 mg (2 tablets), in this case discontinue abiraterone acetate (see 
below). Resumption should not occur until AST, ALT, or bilirubin returns to ≤Grade 1 
or baseline value. 

If Grade 3 increases in AST, ALT, or bilirubin recur at the second dose reduction 
(500 mg [2 tablets]) dose reduction, subjects must discontinue abiraterone acetate 
immediately and will not be rechallenged. The subject should be followed until 
resolution of abnormal liver function tests.

If Grade 4 increases in AST, ALT, or bilirubin occur (eg, increase in AST or ALT to 
>20X ULN; increase in total bilirubin to >10X ULN), subjects must discontinue abiraterone 
acetate immediately and not be rechallenged. The subject should be followed until resolution 
of abnormal liver function tests. 
6.1.5.
Management of Non-Mineralocorticoid Side Effects

If Grade 1 or 2 toxicities occur, supportive management per investigator. No abiraterone 
acetate dose reduction.

If Grade 3 or higher toxicities occur, including headache (interferes with activities of daily 
living), nausea (total parenteral nutrition/intravenous fluids), vomiting (6 or more episodes 
in 24 hours, total parenteral nutrition/intravenous fluids), diarrhea (intravenous fluids, 
hospitalization, hemodynamic collapse), or any other toxicity judged related to study drug is 
observed where the subjects safety is jeopardized, hold abiraterone acetate.

If toxicity recurs, withhold abiraterone acetate, and adjust or add medications to mitigate the 
toxicity. When toxicity resolves to Grade 1, resume abiraterone acetate with the first dose 
level reduction. 

If toxicity recurs, withhold abiraterone acetate, and adjust or add medications to mitigate the 
toxicity. When toxicity resolves to Grade 1, resume study drug with the second dose level 
reduction (500 mg [2 tablets]) unless the dose was already at 500 mg (2 tablets), in this case 
discontinue abiraterone acetate.

If toxicity recurs despite optimal medical management and at a dose of 500 mg (2 tablets), 
then discontinue abiraterone acetate. 


JNJ-212082 (abiraterone acetate)
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7.
TREATMENT COMPLIANCE
Accurate records of all drug shipments as well as tablets dispensed and returned will be 
maintained. This inventory must be available for inspection by designated sponsor or regulatory 
authority representatives at any time. Drug supplies are to be used only in accordance with this 
protocol and under the supervision of the investigator. Study drug administration and dosing 
compliance should be assessed every 3 months. A count of all study drug provided by the 
sponsor will be conducted in the Treatment Phase.
The study site must maintain accurate records demonstrating dates and amount of study drug 
received, to whom dispensed (subject by subject accounting), and accounts of any study drug 
accidentally or deliberately destroyed. Reconciliation must be made between the amount of study 
drug supplied, dispensed, and subsequently destroyed or returned to sponsor or its representative.
8.
CONCOMITANT THERAPY

Supportive care medications should be used according to institutional guidelines. Subjects 
with prostate cancer who did not undergo orchiectomy, must receive concurrent treatment 
with a luteinizing hormone-releasing hormone (LHRH) agonist.

Anti-bone resorptive therapies, such as bisphosphonates are permitted; calcium and vitamin 
D supplementation are permitted.

Other anticancer cytotoxic, immunotherapy or hormonal (except LHRH) agents should not 
be used during treatment with abiraterone acetate (however, concomitant radiation therapy is 
permitted). Use of investigational drug therapy for any reason is prohibited.

Concomitant therapy with aldactone or spironol should not be prescribed.
8.1.
Potential for Drug-Drug Interactions
Abiraterone acetate is an inhibitor of the hepatic drug-metabolizing cytochrome P450 enzyme,
CYP2D6. In a CYP2D6 drug-drug interaction study, the Cmax and AUC of dextromethorphan 
(CYD2D6 substrate) were increased 2.8-fold and 2.9-fold, respectively, when dextromethorphan 
was given with abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily. Avoid 
co-administration of abiraterone acetate with substrates of CYP2D6 with a narrow therapeutic 
index (eg, thioridazine). If alternative treatments cannot be used, exercise caution and consider a 
dose reduction of the concomitant CYP2D6 substrate drug. 
Based on in vitro data, abiraterone is a substrate of CYP3A4. In a clinical pharmacokinetic 
interaction study of healthy subjects pretreated with a strong CYP3A4 inducer, rifampicin, 
600 mg daily for 6 days followed by a single dose of abiraterone acetate 1,000 mg, the mean 
plasma AUC∞ of abiraterone was decreased by 55%. Strong inducers of CYP3A4 
(e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St John's wort 
[Hypericum perforatum]) during treatment with abiraterone acetate are to be avoided, or used 
with careful evaluation of clinical efficacy. In a separate clinical pharmacokinetic interaction 
study of healthy subjects, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had 
no clinically meaningful effect on the pharmacokinetics of abiraterone.


JNJ-212082 (abiraterone acetate)
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Investigators
may 
consult 
listings 
of 
medications
that 
may 
have 
the 
potential 
for cytochrome P450 
drug-drug 
interactions 
at 
http://www.fda.gov/Drugs/Development
ApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm093664.htm. If at any 
time an investigator suspects a drug-drug interaction due to abiraterone acetate therapy, an 
adverse event report should be filed.
For the most accurate and current information regarding potential drug-drug interactions with 
abiraterone acetate, refer to the latest version of the Investigator Brochure for abiraterone 
acetate.1
9.
STUDY EVALUATIONS
9.1.
Study Procedures
9.1.1.
Overview
The Time and Events Schedule summarizes the frequency and timing of suggested evaluations 
applicable to this study.
9.1.1.1.
Screening and Treatment Phase
All subjects must sign informed consent before conduct of any study procedure, and must satisfy 
all the inclusion criteria and none of the exclusion criteria listed in Sections 4.1 and 4.2
respectively, before starting the Treatment Phase. During the Treatment Phase, subjects will 
receive daily treatment with the abiraterone acetate and low dose corticosteroid dosing regimen 
they received in the previous study. Subjects enrolling in this study are moving over from a 
completed abiraterone acetate study and would have received at least 3 months (3 cycles) of 
abiraterone acetate treatment. For consistency, the subjects will restart at Cycle 1, Day 1 when 
they receive the first dose of study medication in this study. 
9.1.1.2.
End-of-Treatment Visit
Safety follow-up will continue for a maximum duration of 6 years from the protocol INT-1 issue 
date (9 April 2012). Subjects should be followed for a safety assessment at least 30 days after the 
last dose of abiraterone acetate. The follow-up can take place as a scheduled visit or phone call at 
the discretion of the investigator. 
9.2.
Efficacy Evaluations
Investigators should monitor and assess the subjects for response to treatment or progression 
according to routine practice or as clinically indicated to determine whether continued treatment 
with abiraterone acetate is warranted. Suggested timing and assessments are outlined in the Time 
and Events Schedule. Any evaluations or findings should be documented in the source medical
record. No efficacy data will be collected and analyzed by the sponsor for this study.
9.3.
Safety Evaluations
Vital signs, physical examinations, clinical laboratory tests, and adverse events should be 
monitored and evaluated by the investigator according to routine practice. Suggested timing and 
assessments are outlined in the Time and Events Schedule. The timing of assessments should be 


JNJ-212082 (abiraterone acetate)
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modified to meet local label requirements or as clinically indicated. Safety evaluations and 
adverse events should be documented in the source medical record. Any serious adverse event 
occurring during the study must be reported to the sponsor by investigational staff within 
24 hours of their knowledge of the event. The sponsor will only collect serious adverse event 
data by the serious adverse event reporting process as described in Section 12.3.2. No other 
safety data will be collected and analyzed by the sponsor.
10.
SUBJECT COMPLETION/WITHDRAWAL
10.1.
Completion
A subject is considered to have completed the study once they have discontinued treatment for 
any reason and had a follow-up safety assessment at least 30 days after the last dose of 
abiraterone acetate. Safety follow-up will continue for a maximum duration of 6 years from the 
protocol INT-1 issue date (9 April 2012).
10.2.
Withdrawal From the Study
Subjects can be withdrawn from the study if an alternative access (eg, patient-assistance program 
or commercial source of abiraterone acetate) is available and feasible.
A subject will be withdrawn from the study for any of the following reasons:

Lost to follow-up

Withdrawal of consent

Discontinuation of study treatment. A subject's study treatment will be discontinued if:

The investigator or sponsor believes (eg, that for safety or tolerability reasons such as 
an adverse event) that it is in the best interest of the subject to stop treatment

The investigator believes the subject is no longer receiving clinical benefit from 
continued abiraterone acetate treatment

The sponsor terminates the study
11.
STATISTICAL METHODS
No formal statistical analyses are planned.
11.1.
Sample Size Determination
The sample size for this study is not powered according to statistical calculation. It is estimated 
that approximately 300 subjects may participate in this study. The number of subjects enrolled 
will depend on the number of subjects from other abiraterone acetate studies who are still 
receiving treatment at the time that a study is considered complete.
12.
ADVERSE EVENT REPORTING
Timely, accurate, and complete reporting and analysis of safety information from clinical studies 
are crucial for the protection of subjects, investigators, and the sponsor, and are mandated by 
regulatory agencies worldwide. The sponsor has established Standard Operating Procedures in 


JNJ-212082 (abiraterone acetate)
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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.
For this study, the investigators should document adverse events in the source medical records 
and report serious adverse events as specified in Section 12.3.2. 
12.1.
Definitions
12.1.1.
Adverse Event Definitions and Classifications
Adverse Event
An adverse event is any untoward medical occurrence in a clinical study subject administered a 
medicinal (investigational or non-investigational) product. An adverse event does not necessarily 
have a causal relationship with the treatment. 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 
International Conference on Harmonisation [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 the signing of the informed consent form 
(refer to Section 12.3.1, All Adverse Events, 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 subject 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 subject 


JNJ-212082 (abiraterone acetate)
Clinical Protocol 212082PCR3010 – Amendment INT-2
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or may require intervention to prevent one of the other outcomes listed in the definition above. 
These should usually be considered serious.
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 an investigational product, the expectedness 
of an adverse event will be determined by whether or not it is listed in the Investigator's 
Brochure. For a non-sponsor investigational medicinal product (eg, a comparator product) with a 
marketing authorization, the expectedness of an adverse event will be determined by whether or 
not it is listed in the package insert/summary of product characteristics.
Adverse Event Associated With the Use of the Drug
An adverse event is considered associated with the use of the drug if the attribution is doubtful,
possible, probable, or very likely by the definitions listed in Section 12.1.2.
12.1.2.
Attribution Definitions
Not Related
An adverse event that is not related to the use of the drug.
Doubtful
An adverse event for which an alternative explanation is more likely, eg, concomitant drug(s), 
concomitant disease(s), or the relationship in time suggests that a causal relationship is unlikely.
Possible
An adverse event that might be due to the use of the drug. An alternative explanation, 
eg, concomitant drug(s), concomitant disease(s), is inconclusive. The relationship in time is 
reasonable; therefore, the causal relationship cannot be excluded.
Probable
An adverse event that might be due to the use of the drug. The relationship in time is suggestive 
(eg, confirmed by dechallenge). An alternative explanation is less likely, eg, concomitant 
drug(s), concomitant disease(s).
Very Likely
An adverse event that is listed as a possible adverse reaction and cannot be reasonably explained 
by an alternative explanation, eg, concomitant drug(s), concomitant disease(s). The relationship 
in time is very suggestive (eg, it is confirmed by dechallenge and rechallenge).
12.1.3.
Severity Criteria 
The NCI-CTCAE Version 4.0 may be used to grade the severity of adverse events. Adverse 
events not listed in the NCI-CTCAE may be graded as follows.


JNJ-212082 (abiraterone acetate)
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
Grade 1: Mild adverse event; asymptomatic or mild symptoms; clinical or diagnostic 
observations only; intervention not indicated

Grade 2: Moderate adverse event; minimal, local or noninvasive intervention indicated; 
limiting age-appropriate instrumental activities of daily living

Grade 3: Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care 
activities of daily living

Grade 4: Life-threatening consequences; urgent intervention indicated

Grade 5: Death related to the adverse event
12.2.
Special Reporting Situations
Safety events of interest on a sponsor medicinal product that may require expedited reporting 
and/or safety evaluation include, but are not limited to:

Overdose of a sponsor medicinal product

Suspected abuse/misuse of a sponsor medicinal product

Inadvertent or accidental exposure to a sponsor medicinal product

Any failure of expected pharmacologic action (ie, lack of effect) of a sponsor medicinal 
product

Unexpected therapeutic or clinical benefit from use of a sponsor medicinal product

Medication error involving a sponsor product (with or without subject/patient exposure to 
the sponsor medicinal product, eg, name confusion)
Special reporting situations should be recorded in the source medical record. Any special 
reporting situation that meets the criteria of a serious adverse event should also be reported to the 
sponsor as indicated in Section 12.3.2.
12.3.
Procedures
12.3.1.
All Adverse Events
All adverse events and special reporting situations, whether serious or non-serious, will be 
recorded in the source medical record from the time a signed and dated informed consent form is 
obtained until completion of the subject'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 abiraterone acetate, 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.
Disease progression should not be reported as an adverse event. However, the signs and 
symptoms of clinical sequelae resulting from disease progression should be reported if they 
fulfill the serious adverse event definition (see Section 12.1.1, Adverse Event Definitions and 
Classification). All events that meet the definition of a serious adverse event will be reported as 
serious adverse events, regardless of whether they are protocol-specific assessments.


JNJ-212082 (abiraterone acetate)
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All adverse events, regardless of seriousness, severity, or presumed relationship to study therapy, 
must be recorded using medical terminology in the source medical record. 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 source medical record 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 medical record and reported according to sponsor 
instructions.
The sponsor assumes responsibility for appropriate reporting of adverse events to the regulatory 
authorities. 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 Independent 
Ethics Committee/Institutional Review Board (IEC/IRB) that approved the protocol unless 
otherwise required and documented by the IEC/IRB.
Subjects (or their designees, if appropriate) must be provided with a "study card" indicating the 
following:

Subject's name

Subject number

Subject's date of birth

Study site number

Investigator's name and 24-hour contact information

Local sponsor's name and 24-hour contact information

Statement that the subject is participating in a clinical trial.
12.3.2.
Serious Adverse Events
Any serious adverse event occurring during clinical studies must be reported to the appropriate 
sponsor contact person by investigational staff within 24 hours of their knowledge of the event.
Information regarding serious adverse events will be transmitted to the sponsor using the Serious 
Adverse Event Form, which must be completed and signed by a member of the investigational 
staff, and transmitted to the sponsor within 24 hours. The initial and follow-up reports of a 
serious adverse event should be made by facsimile (fax).
Any serious adverse event that has not resolved by the end of the study, or that has not resolved 
upon discontinuation of the subject's participation in the study, must be followed until any of the 
following occurs:

The event resolves

The event stabilizes


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
The event returns to baseline, if a baseline value/status is available

The event can be attributed to agents other than the study drug or to factors unrelated to 
study conduct

It becomes unlikely that any additional information can be obtained (subject 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 subject's participation in a clinical 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 source 
medical record)
Disease progression should not be recorded as an adverse event or serious adverse event term; 
instead, signs and symptoms of clinical sequelae resulting from disease progression/lack of 
efficacy will be reported if they fulfill the serious adverse event definition (see Section 12.1.1, 
Adverse Event Definitions and Classifications).
12.4.
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 on the Contact Information 
page(s), which will be provided as a separate document.
13.
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, or reliability of a product, including its labeling or package integrity. A PQC may have 
an impact on the safety and efficacy of the product. Timely, accurate, and complete reporting and 
analysis of PQC information from clinical studies are crucial for the protection of subjects, 
investigators, and the sponsor, and are mandated by regulatory agencies worldwide. The sponsor 
has established procedures in conformity with regulatory requirements worldwide to ensure 
appropriate reporting of PQC information; all clinical studies conducted by the sponsor or its 
affiliates will be conducted in accordance with those procedures.
13.1.
Procedures
All initial PQCs must be reported to the sponsor by the investigational staff as soon as possible 
after being made aware of the event.
If the defect is combined with a serious adverse event, the investigational staff must report the 
PQC to the sponsor according to the serious adverse event reporting timelines (refer to 


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Section 12.3.2, Serious Adverse Events). A sample of the suspected product should be 
maintained for further investigation if requested by the sponsor.
13.2.
Contacting Sponsor Regarding Product Quality
The names (and corresponding telephone numbers) of the individuals who should be contacted 
regarding product quality issues are listed on the Contact Information page(s), which will be 
provided as a separate document.
14.
STUDY DRUG INFORMATION
14.1.
Physical Description of Study Drug(s)
The abiraterone acetate 250-mg tablets supplied for this study are oval, white to off-white, and 
contain abiraterone acetate and compendial-grade (USP/NF/EP) lactose monohydrate, 
microcrystalline cellulose, croscarmellose sodium, povidone, sodium lauryl sulfate, magnesium 
stearate, and colloidal silicon dioxide. Refer to the Investigator's Brochure for additional 
information.
Prednisone (or prednisolone in regions where prednisone is not marketed), 5mg tablets will be 
prescribed by the investigator. In some regions, prednisone/prednisolone may be provided by the 
sponsor. Any other low dose corticosteroids will be prescribed by the investigator. 
14.2.
Packaging
Abiraterone acetate will be supplied by the sponsor as 250-mg tablets packaged in high-density 
polyethylene bottles with child-resistant closures. There are 120 tablets per bottle.
14.3.
Labeling
Study drug labels will contain information to meet the applicable regulatory requirements.
14.4.
Preparation, Handling, and Storage 
The study treatment must be stored in a secure area and administered only to patients entered 
into the clinical study in accordance with the conditions specified in this protocol.
Bottles of abiraterone acetate should be stored at room temperature between 15º to 30º C with the 
cap on tightly and should not be refrigerated.
Refer to the pharmacy manual/site investigational product manual for additional guidance on study 
drug preparation and handling.
14.5.
Drug Accountability
The investigator is responsible for ensuring that all study drug received at the site is inventoried 
and accounted for throughout the study. The dispensing of study drug to the subject, and the 
return of study drug from the subject (if applicable), must be documented on the drug 
accountability form. Subjects must be instructed to return all original containers, whether empty 
or containing study drug. 


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Study drug 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 drug and study drug returned by the subject, must be 
available for verification by the sponsor's site monitor during on-site monitoring visits. The 
return to the sponsor of unused study drug or used returned study drug for destruction will be 
documented on the drug return form. When the site is an authorized destruction unit and study 
drug supplies are destroyed on site, this must also be documented on the drug return form.
Study drug should be dispensed under the supervision of the investigator or a qualified member 
of the investigational staff, or by a hospital/clinic pharmacist. Study drug will be supplied only to 
subjects participating in the study. Returned study drug must not be dispensed again, even to the 
same subject. Whenever a subject brings his or her study drug to the site for pill count, this is not 
seen as a return of supplies. Study drug may not be relabeled or reassigned for use by other 
subjects. The investigator agrees neither to dispense the study drug from, nor store it at, any site 
other than the study sites agreed upon with the sponsor.
15.
STUDY-SPECIFIC MATERIALS
The investigator will be provided with the following supplies:

Investigator Brochure for abiraterone acetate

Pharmacy manual/site investigational product manual

NCI-CTCAE Version 4.0

Interactive Web Response System (IWRS) Manual 

Subject cards
16.
ETHICAL ASPECTS
16.1.
Study-Specific Design Considerations
This study is designed to collect long-term follow-up safety data from subjects in completed 
abiraterone acetate studies for a maximum duration of 6 years from the protocol INT-1 issue date 
(9 April 2012). The study requires that serious adverse events are reported as outlined in 
Section 12.3.2. The study is not designed to evaluate efficacy.
Potential subjects will be fully informed of the risks and requirements of the study and, during the 
study, subjects 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 subjects who are fully able to understand the risks, benefits, and 
potential adverse events of the study, and provide their consent voluntarily will be enrolled. 
The total blood volume to be collected is considered to be within the normal range allowed for this 
subject population over this time frame.


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16.2.
Regulatory Ethics Compliance
16.2.1.
Investigator Responsibilities
The investigator is responsible for ensuring that the clinical study is performed in accordance 
with the protocol, current ICH guidelines on Good Clinical Practice (GCP), and applicable 
regulatory and country-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 subjects. 
Compliance with this standard provides public assurance that the rights, safety, and well-being of 
study subjects are protected, consistent with the principles that originated in the Declaration of 
Helsinki, and that the clinical study data are credible.
16.2.2.
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 informed consent form (and any other written materials to be provided to 
the subjects)

Investigator's Brochure (or equivalent information) and amendments/addenda

Sponsor-approved subject recruiting materials and subject information cards

Information on compensation for study-related injuries or payment to subjects 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 subjects

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 subjects, data or study conduct), the informed consent form, applicable 
recruiting materials, subject information cards and subject 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.
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 subjects, data or study conduct)


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
Revision(s) to informed consent form and any other written materials to be provided to 
subjects

If applicable, new or revised subject recruiting materials approved by the sponsor

Revisions to compensation for study-related injuries or payment to subjects for participation 
in the study, if applicable

New edition(s) of the Investigator's Brochure 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 
investigational drug

New information that may adversely affect the safety of the subjects or the conduct of the 
study

Deviations from or changes to the protocol to eliminate immediate hazards to the subjects

Report of deaths of subjects 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
For all protocol amendments (excluding the ones that are purely administrative, with no 
consequences for subjects, data or trial conduct), the amendment and applicable informed 
consent form 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 clinical study. The 
reapproval should be documented in writing (excluding the ones that are purely administrative, 
with no consequences for subjects, data, or study conduct).
At the end of the study, the investigator (or sponsor where required) will notify the IEC/IRB 
about the study completion.
16.2.3.
Informed Consent
Each subject must give written consent according to local requirements after the nature of the 
study has been fully explained. The consent form must be signed before performance of any 
study-related activity. The consent form that is used must be approved by both the sponsor and 
by the reviewing IEC/IRB and be in a language that the subject can read and understand. 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 investigational 
staff must explain to potential subjects the aims, methods, reasonably anticipated benefits, and 
potential hazards of the study, and any discomfort participation in the study may entail. Subjects 


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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 subject will receive for the treatment of his or her disease. Subjects will be told that 
alternative treatments are available if they refuse to take part and that such refusal will not 
prejudice future treatment. Finally, they will be told that the investigator will maintain a subject 
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 staff without violating the 
confidentiality of the subject, to the extent permitted by the applicable law(s) or regulations. By 
signing the informed consent form the subject is authorizing such access, and agrees to allow his 
or her study physician to recontact the subject for the purpose of obtaining consent for additional 
safety evaluations, if needed, and subsequent disease-related treatments, or to obtain information 
about his or her survival status.
The subject will be given sufficient time to read the informed consent form and the opportunity 
to ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's personally dated signature. After having 
obtained the consent, a copy of the informed consent form must be given to the subject.
If the subject is unable to read or write, an impartial witness should be present for the entire 
informed consent process (which includes reading and explaining all written information) and 
should personally date and sign the informed consent form after the oral consent of the subject is 
obtained.
When prior consent of the subject is not possible, enrollment procedures should be described in 
the protocol with documented approval/favorable opinion by the IEC/IRB to protect the rights, 
safety, and well-being of the subject and to ensure compliance with applicable regulatory 
requirements. The subject must be informed about the study as soon as possible and give consent 
to continue.
16.2.4.
Privacy of Personal Data
The collection and processing of personal data from subjects 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 study subjects confidential.
The informed consent obtained from the subject includes explicit consent for the processing of 
personal data and for the investigator 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.


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The subject 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.
16.2.5.
Country Selection
This study will only be conducted in those countries where the intent is to launch or otherwise 
help ensure access to the developed product, unless explicitly addressed as a specific ethical 
consideration in Section 16.1, Study-Specific Design Considerations.
17.
ADMINISTRATIVE REQUIREMENTS
17.1.
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 subjects, 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 or its designee. When the change(s) involves only logistic or administrative aspects of 
the study, the IRB (and IEC 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 (see Contact Information page(s) provided separately). 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 medical source records will 
reflect any departure from the protocol, and the source documents will describe this departure 
and the circumstances requiring it.
17.2.
Regulatory Documentation
17.2.1.
Regulatory Approval/Notification
This protocol and any amendment(s) must be submitted to the appropriate regulatory authorities 
in each respective country, if applicable. A study may not be initiated until all local regulatory 
requirements are met.
17.2.2.
Required Prestudy Documentation
The following documents must be provided to the sponsor before shipment of study drug to the 
investigational site:

Protocol and amendment(s), if any, signed and dated by the principal investigator


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
A copy of the dated and signed (or sealed, where appropriate per local regulations), written 
IEC/IRB approval of the protocol, amendments, informed consent form, any recruiting 
materials, and if applicable, subject 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 investigational staff 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 subject:

Completed investigator financial disclosure forms from all clinical 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
17.3.
Subject Identification, Enrollment, and Screening Logs
The investigator agrees to complete a subject identification and enrollment log to permit easy 
identification of each subject during and after the study. This document will be reviewed by the 
sponsor site contact for completeness.
The subject identification and enrollment log will be treated as confidential and will be filed by 
the investigator in the study file. To ensure subject confidentiality, no copy will be made. All 
reports and communications relating to the study will identify subjects by subject ID and date of 
birth. In cases where the subject is not randomized into the study, the date seen and date of birth 
will be used.
The investigator must also complete a subject screening log, which reports on all subjects who 
were seen to determine eligibility for inclusion in the study.


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17.4.
Source Documentation
At a minimum, source documentation must be available for the following: subject identification, 
eligibility, and study identification; study discussion and date of informed consent; dates of 
visits; results of safety and efficacy parameters; record of all adverse events and follow-up of 
adverse events; concomitant medication; drug receipt/dispensing/return records; study drug
administration information; and date of study completion and reason for early discontinuation of 
study drug or withdrawal from the study, if applicable. 
In addition, the author of an entry in the source documents should be identifiable.
At a minimum, the type and level of detail of source data available for a study subject should be 
consistent with that commonly recorded at the site as a basis for standard medical care. Specific 
details required as source data for the study will be reviewed with the investigator before the 
study and will be described in the monitoring guidelines (or other equivalent document).
17.5.
Case Report Form Completion
No case report forms will be provided. All information will be documented in the source medical
record.
17.6.
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 
associated personnel before the study, and periodic monitoring visits by the sponsor. 
17.7.
Record Retention
In compliance with the ICH/GCP guidelines, the investigator/institution will maintain all source 
documents that support the data collected from each subject, 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.
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 


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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 must permit access to such reports.
17.8.
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 site. The first 
post-initiation visit will be made as soon as possible after enrollment has begun. The nature and 
location of all source documents will be identified to ensure that all sources of original data are 
known to the sponsor and investigational staff and are accessible for verification by the sponsor 
site contact. If electronic records are maintained at the investigational site, the method of 
verification must be discussed with the investigational staff. 
The sponsor expects that, during monitoring visits, the relevant investigational staff will be 
available, the source documentation 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.
17.9.
Study Completion/Termination
17.9.1.
Study Completion
The study is considered completed with the last visit for the last subject participating in the study
or at the time the sponsor terminates the study. The final data from the investigational site will be 
sent to the sponsor (or designee) after completion of the final subject visit at that site, in the time 
frame specified in the Clinical Trial Agreement.
17.9.2.
Study Termination
The sponsor reserves the right to close the investigational site or terminate the study at any time
for any reason at the sole discretion of the sponsor. Investigational sites will be closed upon 
study completion. An investigational site is considered closed when all required documents and 
study supplies have been collected and a site closure visit has been performed.
The investigator may initiate 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 an investigational 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 subjects by the investigator

Discontinuation of further drug development


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17.10. On-Site Audits
Representatives of the sponsor's clinical quality assurance department may visit the 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. Subject privacy must, however, be respected. The 
investigator and staff are responsible for being present and available for consultation during 
routinely scheduled 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 they have been 
contacted by a regulatory agency concerning an upcoming inspection.
17.11. Use of Information and Publication
All information, including but not limited to information regarding abiraterone acetate 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 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 written 
consent.
The investigator understands that the information developed in the clinical study will be used by 
the sponsor in connection with the continued development of abiraterone acetate 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.
A minimum Clinical Study Report (CSR) will be generated by the sponsor at the completion of 
the study. This synoptic report will include a description of the study, the number of subjects 
enrolled and treatment administered, and a listing of serious adverse events. 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. 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 guidelines, the sponsor shall have the right to publish such data and information without 
approval from the investigator. 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 


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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 substudy 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 site until the combined results from the completed study have been submitted 
for publication, within 12 months of the availability of the final data (tables, listings, graphs), 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 Uniform Requirements for Manuscripts Submitted to Biomedical Journals, which state that 
the named authors must have made a significant contribution to the design of the study or 
analysis and interpretation of the data, provided critical review of the paper, and given final 
approval of the final version.
Registration of Clinical Studies and Disclosure of Results
The sponsor will register and/or disclose the existence of and the results of clinical studies as 
required by law.


JNJ-212082 (abiraterone acetate)
Clinical Protocol 212082PCR3010 – Amendment INT-2
Approved: 11 March 2015
38
REFERENCES
1.
JNJ-212082 (abiraterone acetate) Investigator's Brochure. Janssen Research and Development. Document ID 
No. EDMS-144937303.
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