Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer
Phase: PHASE2
Conditions: Prostatic Neoplasms
Sponsor: Montefiore Medical Center

Title:  Abiraterone with Discontinuation of 
Gonadotropin-Releasing Hormone Analogues in 
Metastatic Prostate Cancer
NCT03565835
IRB#:  2017-8506
IRB Approval Date:  01/27/2025
IRB NUMBER: 2017-8506
IRB APPROVAL DATE: 01/27/2025

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PROTOCOL TITLE
Abiraterone with Discontinuation of Gonadotropin-Releasing Hormone Analogues in 
Metastatic Prostate Cancer
Principal Investigator: 
Benjamin A. Gartrell, MD, Director of Genitourinary Oncology, 
Montefiore Medical Center and the Albert Einstein College of 
Medicine, Assistant Professor, Departments Urology and Medical 
Oncology, 1695 Eastchester Rd, Bronx, NY, 10461. Phone: 718-405-
8505. Fax 718-405-8433
Associate Investigators:
Sanjay Goel, MD, Montefiore Medical Center and the Albert 
Einstein College of Medicine, Professor of Medical Oncology
Janaki Sharma, MD, Montefiore Medical Center and the Albert 
Einstein College of Medicine, Assistant Professor of Medical 
Oncology
Shankar Viswanathan, Dr.P.H., the Albert Einstein College of 
Medicine, Assistant Professor, Department of Epidemiology and 
Population Health, 
TITLE
Abiraterone with Discontinuation of Gonadotropin-Releasing Hormone 
Analogues in Metastatic Prostate Cancer
BACKGROUND
Abiraterone inhibits the CYP17A enzyme, which is a critical enzyme in 
androgen biosynthesis. Abiraterone has regulatory approval in metastatic 
castration-resistant prostate cancer (mCRPC) in both chemotherapy-naïve 
and in the post-docetaxel setting based upon results from two randomized 
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phase III studies. Abiraterone is also proven to extend survival in the 
metastatic, hormone-naïve population based on two phase III studies. 
Abiraterone is a castrating agent, but, other than a small first in human 
study, all clinical studies have been done in conjunction with gonadotropin-
releasing hormone (GnRH) analogues. Maintaining castrate level of serum 
testosterone is critical in the treatment of metastatic prostate cancer. It is 
unknown if GnRH analogues must be continued to maintain castrate levels 
of serum testosterone in patients treated with abiraterone. 
STUDY PHASE 
Single arm feasibility study
OBJECTIVES
Primary objective:

To assess the proportion of patients with a non-castrate testosterone
level (>50 ng/dl) when abiraterone acetate plus prednisone is used
without GnRH analogues in metastatic prostate cancer.
Secondary objectives: 

To measure serum luteinizing hormone (LH) level in patients with
metastatic prostate cancer treated with abiraterone acetate plus
prednisone without a GnRH analogue.

To measure PSA response rate, radiographic progression-free
survival (rPFS) and median overall survival in patient with
metastatic prostate cancer treated with abiraterone acetate plus
prednisone without a GnRH analogue.

To monitor the safety profile of abiraterone acetate plus prednisone
without a GnRH analogue in metastatic prostate cancer.
STUDY DESIGN

In this single-arm, phase II study patients with metastatic prostate
cancer will be treated with abiraterone acetate and prednisone
without a GnRH analogue.

During the treatment period, blood work will be monitored to
determine if testosterone rises to non-castrate levels.
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
Data will be utilized from Montefiore Medical Center Cancer 
Registry for a Comparison Group
NUMBER OF 
PATIENTS
A total of 36 patients will be enrolled.
ELIGIBILITY
Inclusion Criteria
1) The patient must be able to provide study-specific informed consent
prior to study entry
2) Age ≥ 18
3) ECOG Performance Status 0-2
4) Pathologically proven diagnosis of prostate adenocarcinoma
5) Patients must have metastatic prostate cancer
6) Patients may have mCRPC or may have metastatic castration-sensitive
disease.
7) Patients must be maintained on a GnRH analogue (agonist (leuprolide,
goserelin, triptorelin, histerelin, deslorin) or antagonist (degarelix))
8) The patient and the investigator have decided that the next line of cancer
therapy will be abiraterone plus prednisone and the initial dose of
abiraterone will be 1000 mg daily. Or patients may already be on
abiraterone with prednisone at a dose of 1000 mg daily along with a
GnRH analogue.
9) Lab values meeting the following criteria
a) Total testosterone level of <50 ng/dl
b) Total bilirubin < 2.0 X Upper Limit of Normal (ULN)
c) Aspartate aminotransferase (AST) ≤ 3 X ULN
d) Alanine aminotransferase (ALT ) ≤  3 X ULN
e) Absolute Neutrophil Count > 1.5 K/mm3
f)
Platelets > 100 K/mm3
g) Hemoglobin ≥9.0 g/dL
h) calculated creatinine clearance ≥ 30 mL/min according to the
following formula
(140 - age) x wt (kg)
72 x creatinine (mg/dl)
Calculated creatinine clearance =
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Exclusion Criteria
10) History of bilateral orchiectomy
11) History of hypopituitarism
12) For patient not yet started on abiraterone with prednisone, uncontrolled
hypertension (systolic blood pressure >170 mm Hg or diastolic blood
pressure >100 mm Hg)
13) Patients must not have New York Heart Association Class III or IV heart
failure at the time of screening. Patients must not have any unstable
angina, myocardial infarction, or serious uncontrolled cardiac
arrhythmia within 6 months prior to registration
14) Any other serious illness or medical condition that the principal
investigator feels would make the patient a poor candidate for this study
Table of Contents
Contents
1
Study Objectives...................................................................................................................................7
1.1
Primary Objective..............................................................................................7
1.2
Secondary Objectives ........................................................................................7
2
Background and Rationale .................................................................................................................7
2.1
Abiraterone in mCRPC......................................................................................8
2.2
Abiraterone in metastatic, hormone-naïve prostate cancer ...............................8
2.3
Abiraterone Without GnRH Analogues ............................................................8
2.4
Testosterone Recovey Following Discontinuation of GnRH Analogues..........9
2.5
Characteristics of Patients Treated with Abiraterone........................................9
2.6
Rationale for Discontinuation of GnRH Analogue with Abiraterone .............10
3
Eligibility Criteria and Registration.....................................................Error! Bookmark not defined.
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3.1
Inclusion Criteria .............................................Error! Bookmark not defined.
3.2 
Exclusion Criteria ............................................Error! Bookmark not defined.
3.3
Screening Evaluation .......................................Error! Bookmark not defined.
3.4
Registration Procedures ...................................Error! Bookmark not defined.
4.0 Study Design...........................................................................................Error! Bookmark not defined.
4.1
General Design ................................................Error! Bookmark not defined.
4.2
Study Calendar.................................................Error! Bookmark not defined.
4.3
Primary Objective............................................................................................13
4.4
Secondary Objective........................................................................................13
5
Therapy...............................................................................................................................................14
5.1
Abiraterone ......................................................................................................14
5.2
Drug Supply and Accountability .....................................................................14
5.3 
Administration.................................................................................................14
5.4
Compliance......................................................................................................14
5.5
Initial Dose and Dose Adjustments .................................................................14
5.6
Monitoring for Benefit and Safety...................................................................15
5.7
Abiraterone Warnings and Precautions ...........................................................15
5.8
Adverse Reactions ...........................................................................................16
5.9
Drug Interactions .............................................................................................16
5.10
Use in Specific Populations.............................................................................16
5.11
GnRH Analogues with Abiraterone ................................................................16
6 
Study Procedures ...............................................................................................................................16
6.1
Identification of Study Subjects ......................................................................16
6.2
Screening Period..............................................................................................17
6.2.1 
Studies Required for Screening .......................................................................17
6.3 
Study Visits......................................................................................................17
6.4 
End of Treatment Visit ....................................................................................17
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6.5
Follow Up........................................................................................................18
7
 Endpoints...........................................................................................................................................18
7.1 
Evaluation of Primary Objective .....................................................................18
7.2 
Additional Endpoints.......................................................................................18
7.3 
Duratio of Trial Participation ..........................................................................19
8 
Statistical Considerations..................................................................................................................19
8.1 
Subject Accrual................................................................................................20
9 
Regulatory considerations.................................................................................................................20
9.1 
Protection of Human Subjects .........................................................................20
9.2 
Compliance with the Protocol and Protocol Revisions ...................................20
10 Data Handling and Record Keeping................................................................................................21
10.1 
Confidentiality.................................................................................................21
10.2 
Source Documents...........................................................................................21
10.3 
Case Report Forms ..........................................................................................21
11 Data Safety and Monitoring Boards ................................................................................................22
12 Adverse Events...................................................................................................................................23
12.1 
Adverse Event Definitions...............................................................................23
12.2 
Adverse Event Reporting.................................................................................24
12.3
Serious Adverse Event Reporting....................................................................24
12.3.1
Study Center (Site) Requirements for Reporting SAEs ..................................24
12.3.2
Death and Immediately Life-Threatening Events ...........................................26
13
References...........................................................................................................................................26
14
Appendices..........................................................................................................................................28
14.1
Eligibility Checklist.........................................................................................28
14.2
Pill Log ............................................................................................................30
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1
Study Objectives
1.1
Primary objective:

To assess the proportion of patients with a non-castrate testosterone level (>50 ng/dl) when 
abiraterone acetate plus prednisone is used without GnRH analogues in metastatic prostate 
cancer.
1.2
Secondary objectives: 

To measure serum luteinizing hormone (LH) level in patients with metastatic prostate 
cancer treated with abiraterone acetate plus prednisone without a GnRH analogue.

To measure PSA response rate, radiographic progression-free survival (rPFS) and median 
overall survival in patient with metastatic prostate cancer treated with abiraterone acetate 
plus prednisone without a GnRH analogue.

To monitor the safety profile of abiraterone acetate plus prednisone without a GnRH 
analogue in metastatic prostate cancer.
2
Background and Rationale
Prostate cancer is the second most commonly diagnosed malignancy in men around the world with 
an estimated 1,111,700 new cases and 307,500 deaths per year.[1] Metastatic prostate cancer is 
characterized by a period during which suppression of serum testosterone with androgen 
deprivation therapy (ADT) is sufficient to control disease. Unfortunately, this period is followed 
by transition to castration-resistance during which progression occurs despite continued 
suppression of testosterone. This is referred to as metastatic castration-resistant prostate cancer 
(mCRPC). Formerly, this disease state was known as hormone-refractory prostate cancer. This 
term is no longer used as it is now known that androgen receptor (AR) signaling remains critical 
to disease progression in castration-resistant disease.[2] That prostate-specific antigen (PSA) rises 
in the setting of progression in mCRPC exemplifies this point as PSA is an androgen-regulated 
gene. Maintaining castrate level of serum testosterone is critical in the treatment of mCRPC as 
rising serum testosterone levels is expected to drive disease progression. The clinical relevance of 
targeting androgen signaling in mCRPC is demonstrated by the survival advantage of the second-
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generation androgen pathway targeted agents, abiraterone acetate and enzalutamide, in this disease 
state.[3, 4]
2.1
Abiraterone in mCRPC
Abiraterone inhibits the CYP17A enzyme, a critical enzyme in androgen biosynthesis in both the 
testicles and the adrenal glands. Abiraterone has regulatory approval in metastatic castration-
resistant prostate cancer (mCRPC) in both chemotherapy-naïve and in the post-docetaxel setting 
based upon results from the COU-AA-301 and COU-AA-302 clinical trials, respectively.[3, 4] In 
both clinical trials, abiraterone 1000 mg daily plus prednisone 5 mg twice per day, when used in 
conjunction with GnRH analogues, prolonged median OS.
2.2
Abiraterone in metastatic, hormone-naïve prostate cancer
Two phase III studies evaluating abiraterone acetate in the metastastic, hormone-naïve setting were 
presented at the American Society of Clinical Oncology (ASCO) annual meeting in 2017.  
LATITUDE was a placebo-controlled, phase III trial evaluating abiraterone 1000 mg daily and 
prednisone 5 mg daily versus placebo in patients with newly diagnosed, metastatic hormone naïve 
prostate cancer who were just beginning ADT. There were two primary endpoints (OS and rPFS). 
Abiraterone with prednisone improved OS (median not yet reached v. 34.7 months, HR 0.62; 
P<0.001) and rPFS (33.0 vs. 14.8 months, HR 0.47; P<0.001).[5]  STAMPEDE was a phase III 
trial evaluating abiraterone 1000 mg daily plus prednisolone 5 mg daily with ADT versus ADT 
alone in metastatic, hormone-naïve prostate cancer. The primary endpoint was OS and abiraterone 
with prednisolone improved OS (HR 0.63; P<0.001).[6]  This level 1 evidence is changing the 
standard of care for metastatic, hormone-naïve prostate cancer and it is anticipated that abiraterone 
will receive regulatory approval in this treatment setting. 
2.3
Abiraterone Without GnRH Analogues
The first paper to describe abiraterone acetate was published in 1994.[7]  In this article, a number 
of inhibitors of CYP17A were described. Among the most potent was abiraterone acetate 
(CB7630) the active metabolite of which (abiraterone or CB7598) was shown to suppress serum 
testosterone in mice with a compensatory increase in luteinizing hormone (LH). The first in human 
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dose escalation study of abiraterone acetate was published one decade later.[8] This was a small 
study that investigated the use of abiraterone in three patient cohorts: 
A) 16 patients with prostate cancer treated with GnRH agonists who were treated 
with a single dose of abiraterone (up to 500 mg) 
B) 4 patients with a history of prostate cancer who had been treated with GnRH 
agonists in the past but had recovered serum testosterone to non-castrate values and were 
treated with a single dose of abiraterone (up to 500 mg) 
C) 6 patients with a history of prostate cancer (5 of 6 with previous GnRH agonist) 
and all with non-castrate testosterone levels. Patients were treated with multiple doses of 
abiraterone. An initial 3 patients were treated with abiraterone at 500 mg. All 3 had 
inadequate testosterone suppression. 3 patients were then treated with abiraterone at 800 
mg for multiple doses. All 3 patients treated at 800 mg daily had suppression of testosterone 
but 2 of these had a compensatory rise in LH that led to an increase in testosterone. For this 
reason, future development of abiraterone was done in conjunction with GnRH analogues.  
2.4
Testosterone Recovery Following Discontinuation of GnRH Analogues
A number of publications have reported on testosterone recovery in prostate cancer patients 
following discontinuation of long-term GnRH analogues.[9-11] In a recent report from Planas et. 
al. testosterone recovery was monitored in patients with prostate cancer that had been maintained 
on GnRH analogues for a median duration of 74.6 months.[9] The median age was 71.5 years. The 
mean time to recovery of testosterone to non-castrate level (> 50ng/dl) was 14.5 months for 
patients maintained on GnRH analogues for <60 months and was 29.3 months for patients that had 
been maintained on GnRH analogues for > 60 months. LH recovery was more rapid with half of 
patients showing a rise in LH by 6 months from discontinuation of the GnRH analogue. 
2.5
Characteristics of Patients Treated with Abiraterone
In the COU-AA-302 phase III clinical trial, abiraterone + prednisone was compared to placebo + 
prednisone in chemotherapy-naïve patients with asymptomatic to mildly symptomatic mCRPC.[4] 
Patients were maintained on GnRH analogues through the duration of the study. The starting dose 
of abiraterone was 1000 mg daily. Prednisone was dosed at 5 mg BID. The median age in the 
abiraterone group and the placebo group were 71 and 70 years, respectively. The median duration 
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of GnRH analogues in the abiraterone and placebo groups prior to study entry were 40.4 and 40.8 
months, respectively. This illustrates that the population treated with abiraterone is an elderly 
population that has typically been on long term GnRH analogues. 
2.6
Rationale for Discontinuation of GnRH Analogue when Abiraterone is Used in 
Metastatic Prostate Cancer
As has been demonstrated, the recovery of testosterone following cessation of GnRH analogues is 
often sluggish in patients maintained on long-term ADT. In the reports cited previously, this 
sluggish testosterone recovery is in the absence of ongoing hormone therapy. Abiraterone is a 
potent inhibitor of CY17A which is critical for androgen synthesis in the testicles. We suspect that 
testosterone recovery, should it occur, would likely occur slowly in patients w/ metastatic prostate 
cancer maintained on abiraterone with discontinuation of GnRH analogue.
We believe the cessation of GnRH analogues during the use of abiraterone plus prednisone in 
metastatic prostate cancer is reasonable if serum testosterone is monitored. This clinical trial is 
designed to determine the probability of testosterone recovery to non-castrate levels when GnRH 
analogues are discontinued during the use of abiraterone with prednisone in patients with 
metastatic prostate cancer. . 
3
Eligibility Criteria and Registration
3.1
Inclusion Criteria
1) The patient must be able to provide study-specific informed consent prior to study entry
2) Age ≥ 18
3) ECOG Performance Status 0-2
4) Pathologically proven diagnosis of prostate adenocarcinoma
5) Patients must have metastatic disease
6) Patients may have mCRPC or may have metastatic castration-sensitive disease.
7) Patients must be maintained on a GnRH analogue (agonist (leuprolide, goserelin, triptorelin, 
histerelin, deslorin) or antagonist (degarelix))
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8) The patient and the investigator have decided that the next line of cancer therapy will be 
abiraterone plus prednisone and the initial dose of abiraterone will be 1000 mg daily. Or 
patients may already be on abiraterone with prednisone at a dose of 1000 mg daily along with 
a GnRH analogue. 
9) Lab values meeting the following criteria
a) Total testosterone level of <50 ng/dl
b) Total bilirubin < 2.0 X Upper Limit of Normal (ULN)
c) Aspartate aminotransferase (AST) ≤ 3 X ULN
d) Alanine aminotransferase (ALT ) ≤  3 X ULN 
e) Absolute Neutrophil Count > 1.5 K/mm3
f)
Platelets > 100 K/mm3 
g) Hemoglobin ≥9.0 g/dL
h) calculated creatinine clearance ≥ 30 mL/min according to the following formula
3.2
Exclusion Criteria
1) History of bilateral orchiectomy
2) History of hypopituitarism
3) For patient not yet started on abiraterone with prednisone, uncontrolled hypertension (systolic 
blood pressure >170 mm Hg or diastolic blood pressure >100 mm Hg) 
4) Patients must not have New York Heart Association Class III or IV heart failure at the time of 
screening. Patients must not have any unstable angina, myocardial infarction, or serious 
uncontrolled cardiac arrhythmia within 6 months prior to registration
5) Any other serious illness or medical condition that the principal investigator feels would make 
the patient a poor candidate for this study 
3.3
Screening Evaluation
Within 30 days prior to registration
A. Blood work for CBC, Chem 7, LFTs, PSA, Testosterone, LH
B. Complete history, physical examination, vital signs, review of medications and ECOG 
performance status.
(140 - age) x wt (kg)
72 x creatinine (mg/dl)
Calculated creatinine clearance =
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3.4
Registration Procedures
Patients will be registered through the Office of Clinical Trials at Montefiore Medical Center 
(Phone number: 718-379-6861). The signed informed consent document and the completed cpdmu 
patient registration form must be provided to the Office of Clinical Trials (cpdmu-
registration@montefiore.org) at the time of registration and prior to patient treatment.
At the time of registration, all eligibility criteria must be reviewed. It is the treating physician’s 
responsibility to ensure that patients meet all eligibility criteria. To facilitate this an eligibility 
checklist is provided in the appendix of this protocol. 
4
Study Design
4.1
General Design
This is a single arm, open label feasibility clinical trial that will include patients with metastatic 
prostate cancer who are mainted on a GnRH analogue and are already being treated with or will 
be beginning therapy with abiraterone plus prednisone. For patients being initiated on abiraterone 
with prednisone or for those patients already on abiraterone with prednisone, the GnRH analogue 
will be discontinued. LH and testosterone will be measured during screening and during therapy 
with abiraterone. Monitoring of the patient would be according to the standard of care with the 
exception that the GnRH analogue would be discontinued. Treatment on the protocol would 
continue until abiraterone is permanently discontinued or until testosterone rises to a non-castrate 
value (> 50 ng/dl). Should testosterone become non-castrate, the treating investigator would 
remove the patient from the protocol and resume ADT with a GnRH analogue. In this scenario, 
abiraterone and prednisone would be continued at the discretion of the investigator based upon 
expectation of ongoing benefit to the patient. 
4.2
Study Calendar
The following assessments should be done within 30 days prior to registration
A. Blood work for CBC, Chem 7, LFTs, PSA, Testosterone, LH
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B. Complete history, physical examination, vital signs, review of medications and ECOG 
performance status.
Screening
Q12 Wk1 (+/-1 wk)
EOT
Follow up Q12 Wks (+/-4 wks)
History and Physical 
Examination
X
X
X
Vital Signs
X
X
X
AE Assessment
X
X
X
ECOG PS
X
X
X
CBC
X
Chemistry
X
LFTs2
X
PSA
X
X
X
Testosterone
X
X
X
LH
X
X
X
Tumor Assesment3
X
X
X
Subsequent Therapy
X4
Survival
X
AE: Adverse Event, CBC: complete blood count, EOT: end of trial visit, LFTs: liver function tests, LH: 
luteinizing hormone PS: Performance Status, PSA: Prostate-Specific Antigen
1The first study visit should occur within 28 days of registration onto this study.  
2LFT monitoring is required at the initiation of abiraterone and periodically during ongoing therapy. The 
investigator should refer to the abiraterone package insert to ensure that LFTs are monitored according to 
standard practice
3Tumor assessments are not required but will be done at the discretion of the investigator. Tumor 
assessments done during study therapy will be recorded.
4For prostate cancer
4.3
Primary Objective

To assess the proportion of patients with a non-castrate testosterone level (>50 ng/dl) when 
abiraterone acetate plus prednisone is used without GnRH analogues in metastatic prostate 
cancer.
4.4
Secondary Objectives

To measure serum luteinizing hormone (LH) level in patients with metastatic prostate 
cancer treated with abiraterone acetate plus prednisone without a GnRH analogue.
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
To measure PSA response rate, radiographic progression-free survival (rPFS) and median 
overall survival in patient with metastatic prostate cancer treated with abiraterone acetate 
plus prednisone without a GnRH analogue.

To monitor the safety profile of abiraterone acetate plus prednisone without a GnRH 
analogue in metastatic prostate cancer.
5
 Therapy
5.1
Abiraterone
Abiraterone is an inhibitor of the CYP17A enzyme and is FDA-approved in combination with 
prednisone for the treatment of mCRPC. The recommended starting dose is 1000 mg once daily 
in combination with prednisone at 5 mg BID. Abiraterone is supplied as 250 mg tablets. 
5.2
Drug Supply and Accountability
Abiraterone and prednisone will be prescribed the study investigator. Prescriptions will be sent to 
commercial pharmacies. Abiraterone and prednisone will not be provided by this research study 
and will instead be billed to the patient’s insurance.. 
5.3
Administration
Administration will be as per the product label. Per the label, abiraterone should be taken on an 
empty stomach. Abiraterone should be taken at least two hour after the most recent meal and 
patients should wait at least one hour after taking abiraterone to eat their next meal. Once patients 
begin taking abiraterone, patients must begin taking prednisone. 
5.4
Compliance
Compliance with study drug will be documented with the use of pill logs. 
5.5
Initial Dose and Dose Adjustments
The dosing of abiraterone and prednisone will follow the package insert. It is anticipated that all 
patients on this protocol will begin abiraterone at 1000 mg once daily on an empty stomach. All 
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patients will also begin taking prednisone. Dose adjustments will be at the discretion of the treating 
investigator but are expected to follow dose adjustment recommendations as per the package 
insert. 
5.6
Monitoring for Benefit and Safety
While on protocol, all decisions regarding imaging will be the discretion of the treating investigator 
and will follow local standard of care procedures. The investigator will assess for adverse events 
at each study visit and will follow the package insert and standard procedures for dose holding, 
dose modification and discontinuation of study therapy.  Blood work for safety including 
monitoring of the basic metabolic and liver function tests will be done according to standard 
practice. Per the FDA package insert, liver function tests should be checked prior to beginning 
abiraterone, monitored at 2 week intervals for the first 3 months of therapy and then monthly while 
on abiraterone. Patients treated on this protocol will be monitored according to this guideline. The 
FDA package insert also states that potassium should be checked prior to initiating abiraterone and 
that serum potassium should be monitored for hypokalemia monthly during ongoing therapy with 
abiraterone. 
5.7
Abiraterone Warnings and Precautions
Please see the abiraterone FDA package insert for full prescribing information. The key aspects of 
the package insert are summarized herein. 
According to the FDA package insert there are three warnings and precautions:
1) Mineralocorticoid excess: Use abiraterone with caution in patients with a history of 
cardiovascular disease. The safety of abiraterone in patients with LVEF < 50% or NYHA 
Class II to IV heart failure in Study 2 was not established. Control hypertension and correct 
hypokalemia before treatment. Monitor blood pressure, serum potassium and symptoms of 
fluid retention at least monthly. 
2) Adrenocortical insufficiency: Monitor for symptoms and signs of adrenocortical 
insufficiency. Increased dosage of corticosteroids may be indicated before, during and after 
stressful situations.
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3) Hepatotoxicity: Can be severe and fatal. Monitor liver function and modify, interrupt, or 
discontinue abiraterone dosing as recommended.
5.8
Adverse Reactions
The most common adverse reactions (≥10%) are fatigue, joint swelling or discomfort, edema, hot 
flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion. 
The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, 
hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, 
hypophosphatemia, elevated ALT and hypokalemia.
5.9
Drug Interactions
CYP3A4 Inducers: Avoid concomitant strong CYP3A4 inducers during abiraterone treatment. If 
a strong CYP3A4 inducer must be co-administered, increase the abiraterone dosing frequency. 
CYP2D6 Substrates: Avoid co-administration of abiraterone with CYP2D6 substrates that have a 
narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider 
a dose reduction of the concomitant CYP2D6 substrate.
5.10
Use in Specific Populations
Do not use abiraterone in patients with baseline severe hepatic impairment (Child-Pugh Class C)
5.11
GnRH Analogues with Abiraterone
As previously mentioned in this protocol, the entirety of the clinical development of abiraterone 
has been done so in conjunction with continuation of GnRH analogues. According to the product 
label, patients being treated with abiraterone should be informed that they need to maintain 
treatment with GnRH analogues during therapy with abiraterone and prednisone.
6
Study Procedures
6.1
Identification of Study Subjects
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Patients with metastatic prostate cancer being treated with ongoing ADT with a GnRH analogue 
and are already being treated with abiraterone and prednisone or who will begin abiraterone with 
prednisone will be offered participation in this protocol. Patients will be identified at the 
Montefiore Einstein Center for Cancer Care.
6.2
Screening Period
Patients who are being offered abiraterone acetate plus prednisone will be offered participation in 
this trial. Prior to participating in any study procedures, patients will be provided with an ICF. In 
the event that a patients agrees to participate and signs the ICF they will screened for participation 
in this trial. 
If they are not yet prescribed abiraterone and prednisone but have signed the ICF, they will be 
prescribed abiraterone and prednisone. Abiraterone and prednisone will be provided by a 
commercial pharmacy and will not be provided through participation in this study. 
6.2.1
Studies Required for Screening
Within 30 days prior to registration
A. Blood work for CBC, Chem 7, LFTs, PSA, Testosterone, LH
B. Complete history, physical examination, vital signs, review of medications and ECOG 
performance status.
C. The history of GnRH analogue use will be recorded. The agent, dose and dates 
administered will be recorded. The duration of first GnRH analogue injection will be noted 
as will the date of the last injection prior to trial participation. 
6.3
Study Visits
The first study visit will occur within four weeks (+/- 1 week) of registration. Subsequent study 
visits will be every 12 weeks (+/- 1 week). Procedures at study visits will include
A. Blood work for PSA, Testosterone, LH
B. Complete history, physical examination, vital signs, review of medications and ECOG 
performance status.
6.4
End of Treatment Visit
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A. Blood work for PSA, Testosterone, LH
B. Complete history, physical examination, vital signs, review of medications and ECOG 
performance status.
6.5
Follow Up
Patients will be monitored at 12 week intervals (+/- 4 weeks) after discontinuation of study therapy 
for determination of subsequent therapies and survival. 
7
Endpoints
7.1
Evaluation of Primary Objective
The primary objective of this clinical trial is to determine if serum total testosterone levels become 
non-castrate (≥50 ng/dl) when abiraterone acetate plus prednisone is used without GnRH 
analogues in patients with metastatic prostate cancer. We will monitor testosterone at 12 week 
intervals. The proportion of patients with a castrate level of serum total testosterone (<50 ng/dl) 
after 24 weeks will be the primary endpoint. If a patient is not on abiraterone for 24 weeks as a 
consequence of disease progression, intolerance or other reason the patient will be replaced.  
However, if the patient is found to have a testosterone level of ≥ 50 ng/dl while on abiraterone they 
will not be replaced and this data point will be used for evaluating the primary objective. The 
proportion of patients with a castrate level of serum testosterone at each 12-week interval will be 
reported. 
7.2
Additional endpoints. 

To measure serum luteinizing hormone (LH) level in patients with metastatic prostate 
cancer treated with abiraterone acetate plus prednisone without a GnRH analogue. We will 
record LH values at 12 week intervals and will report the median time until LH rises to be 
within the normal range when abiraterone acetate plus prednisone is used without GnRH 
analogues in metastatic prostate cancer. 

To measure PSA response rate, radiographic progression-free survival (rPFS) and median 
overall survival in patient with metastatic prostate cancer treated with abiraterone acetate 
plus prednisone without a GnRH analogue.
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
To monitor the safety profile of abiraterone acetate plus prednisone without a GnRH 
analogue in metastatic prostate cancer.
7.3
Duration of Clinical Trial Participation
Patients will continue on clinical trial therapy until abiraterone is permanently discontinued, serum 
total testosterone rises to ≥50 ng/dl, a GnRH analogue is given, withdrawl of consent, intolerable 
adverse events, at the time of radiographic progression of disease according to the guidelines of 
the Prostate Cancer Clinical Trials Working Group 3[12], at the time of clinical progression,  or 
when the investigator feels as though it is the patient’s best interest to discontinue therapy in this 
clinical trial. Following discontinuation of clinical trial therapy with abiraterone and prednisone, 
patients will be followed at 12 week intervals for survival and subsequent prostate cancer therapy.
8
Statistical Considerations
This primary aim of this feasibility study is to evaluate the of the proportion of patients whose 
testosterone rises to a non-castrate value (≥50 ng/dl) when abiraterone and prednisone are used 
without a GnRH analogue in the treatment of mCRPC. The   secondary objectives are to measure 
levels of serum LH, PSA response rate, rPFS and median overall survival in these study 
participants. 
The demographic and clinical characteristic of the study participants will be summarized 
numerically using descriptive statistics and graphically (e.g. boxplots). The frequency of 
participants with castrate level of testosterone (<50 ng/dl) will be presented as proportion along 
with its 95% Clopper-Pearson exact confidence interval. The serum LH levels will be presented 
as mean with 95% confidence interval, log transformation will be performed in case of non-normal 
distribution of LH values. If after transformation, normality is not satisfied, we will present it as 
median and inter quartile range (IQR). 
For survival analyses, we will plot Kaplan-Meier survival curves for outcomes of rPFS and overall 
survival from time from start of treatment. The probability of survival will be presented at different 
time points. 
Sample size justification:
This is a feasibility study and no formal power calculation is performed. Based on our experience, 
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we assume that the abiraterone and prednisone without GnRH provides approximately 80% non-
castrate level of serum total testosterone level.  Under this assumption, a sample size of 30 will 
produce a 95% confidence interval with a width equal to 0.31 using Clopper_Pearson exact 
formula (i.e. 0.61, 0.92). Patient dropout is anticipated to be approximately 20%. Therefore it is 
anticipated that 36 patients will be accrued to assess the primary endpoint in 30 patients.
8.1
Subject Accrual
Approximately 40 patients with metastatic prostate cancer are prescribed abiraterone + prednisone 
annually at our center. Assuming that 25% of these patients are enrolled onto this study, it is 
estimated that patient recruitment will take approximately 3-4 years. 
9
Regulatory considerations
9.1
Protection of Human Subjects
The Investigators will ensure that patients, or their legally acceptable representatives, are clearly 
and fully informed about the purpose, potential risks and other critical issues regarding this clinical 
trial. Patients will be required to provide informed consent prior to participating in any aspect of 
this research. The preparation of the informed consent form is the responsibility of the primary 
investigator and will include all elements required by CFR 21 Part 50.25 and the local IRB.
9.2
Compliance with the Protocol and Protocol Revisions
The study must be conducted as described in this approved protocol.  All revisions to the protocol 
must be provided to the primary investigator.  The primary investigator should not implement any 
deviation or change to the protocol without prior review and documented approval/favorable 
opinion from the IRB of an Amendment, except where necessary to eliminate an immediate 
hazard(s) to study patients.
10
Data Handling and Record Keeping
10.1
Confidentiality
Study subject information will be kept confidential and managed according 
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to the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  Those regulations 
require a signed subject authorization informing the subject of the following:

What protected health information (PHI) will be collected from subjects in this study

Who will have access to that information and why

Who will use or disclose that information

The rights of a research subject to revoke their authorization for use of their PHI.
In the event that a subject revokes authorization to collect or use PHI, the investigator, by 
regulation, retains the ability to use all information collected prior to the revocation of subject 
authorization.  For subjects that have revoked authorization to collect or use PHI, attempts should 
be made to obtain permission to collect at least vital status (i.e. that the subject is alive) at the end 
of their scheduled study period.
10.2
Source Documents
Source data is all information, original records of clinical findings, observations, or other activities 
in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are 
contained in source documents. Examples of source documents include: clinical notes, hospital 
records, laboratory results, results of imaging studies and the actual images from imaging studies, 
subjects’ diaries or evaluation checklists, pharmacy dispensing records and other records from the 
pharmacy, all data generated from the research lab pertaining to this research, subject files, and 
any other information that is collected for or generated during subject participation in this clinical 
trial.
10.3
Case Report Forms
The study case report form (CRF) is the primary data collection instrument for the study.  All data 
requested on the CRF must be recorded.  All missing data must be explained.  If a space on the 
CRF is left blank because the procedure was not done or the question was not asked, write “N/D”.  
If the item is not applicable to the individual case, write “N/A”.  All entries should be printed 
legibly in black ink.  If any entry error has been made, to correct such an error, draw a single 
straight line through the incorrect entry and enter the correct data above it.  All such changes must 
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be initialed and dated.  DO NOT ERASE OR WHITE OUT ERRORS.  For clarification of illegible 
or uncertain entries, print the clarification above the item, then initial and date it.  
11
Data Safety and Monitoring Boards
All trials initiated by the Montefiore Medical Center are subject to oversight by the Data Safety 
Monitoring Board (DSMB).  This board meets two times per year with any additional meetings 
scheduled when needed.  The responsibilities are as follows:

Familiarize themselves with the research protocol (s)

Review interim analyses of outcome data and cumulative toxicity data summaries to 
determine whether the trial should continue as originally designed, should be changed, or 
should be terminated based on these data.

The DSMB reviews trial performance information such as accrual information.

The DSMB also determines whether and to whom outcome results should be released prior 
to the reporting of study results.

All adverse events are reviewed by the committee with assurances that these have been in 
fact sent for review to all pertinent IRBs.

Review of reports of related studies to determine whether the monitored study needs to be 
changed or terminated.

Review major proposed modifications to the study prior to their implementation (e.g., 
termination, dropping an arm based on toxicity results or other reported trial outcomes, 
increasing target sample size).

Following each DSMB meeting, provide the study leadership with written information 
concerning findings for the trial as a whole related to cumulative toxicities observed and 
any relevant recommendations related to continuing, changing, or terminating the trial.  
The study leadership will provide information on cumulative toxicities and relevant 
recommendations to the local PI to be shared with their IRB’s.
12
Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical 
investigation subject and does not necessarily have to have a causal relationship with study 
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treatment.  An AE can therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease temporally associated with the use of treatment.  During 
clinical trials, AEs can be spontaneously reported or elicited during open-ended questioning, 
examination, or evaluation of a subject. 
AEs will be recorded in the case report form for the duration of the trial, regardless of whether or 
not the event(s) are considered related to trial intervention or medication. All AEs considered 
related to trial intervention or medication will be followed until resolution, even if this occurs post-
trial.
12.1
Adverse Event Definitions
Adverse Event (AE): Any new, undesirable medical experience or change of an existing condition 
that occurs during or after treatment, whether or not considered product-related.
Serious Adverse Event (SAE): An AE occurring at any dose that results in any of the following 
outcomes (CFR 312.32)

Death

Life-threatening adverse experience

Inpatient hospitalization or prolongation of existing hospitalization

Persistent or significant disability or incapacity

Congenital anomaly / birth defect. 
Important medical events that may not be life-threatening, or require hospitalization may be 
considered serious when, based upon appropriate medical judgment, they may jeopardize the 
patient or subject and may require medical or surgical intervention to prevent one of the outcomes 
listed in the SAE definition. These should also usually be considered serious.  Examples of such 
events are intensive treatment in an emergency room or at home for allergic bronchospasm; blood 
dyscrasias or convulsions that do not result in hospitalization; or development of drug dependency 
or drug abuse.
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Unexpected Adverse Event: An AE that is not mentioned in the Investigator's Brochure or package 
insert or the specificity or severity of which is not consistent with the investigator's brochure or 
package insert.
Life-threatening: Any adverse experience that places the patient or subject, in the view of the 
investigator, at immediate risk of death from the reaction as it occurred.  It does not include a 
reaction that, had it occurred in a more severe form, might have caused death.
AEs will use the descriptions and grading scales found in the revised Common Terminology 
Criteria for Adverse Events (CTCAE) version 4.0.
12.2
Adverse Event Reporting
Adverse events (AEs) will be recorded from the time of consent and for at least 30 days after 
treatment discontinuation, regardless of whether or not the event(s) are considered related to trial 
medications.  All AEs considered related to trial medication will be followed until resolution, 
return to baseline, or deemed clinically insignificant, even if this occurs post-trial.
12.3
Serious Adverse Event Reporting
12.3.1 Study Center (Site) Requirements for Reporting SAEs
Investigators and other site personnel must report all SAEs occurring during the course of the study 
within 24 hours of discovery via phone, email, or fax.  This includes both SAEs unrelated and 
related to the investigational product.  In general, SAEs assessed as clearly being due to disease 
progression, and not due to study drug(s), should be excluded from AE reporting.  Study-specific 
clinical outcomes of death because of disease progression are exempt from SAE reporting, unless 
the investigator deems them related to use of the study drug.  Hospitalization for radical 
prostatectomy is not an SAE.
The definition of “related” being that there is a reasonable possibility the drug caused the adverse 
experience.
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Unrelated
The Adverse Event is clearly not related to the investigational agent(s)
Unlikely
The Adverse Event is doubtfully related to the investigational agent(s)
Possible
The Adverse Event is may be related to the investigational agent(s)
Probable
The Adverse Event is likely related to the investigational agent(s)
Definite
The Adverse Event is clearly related to the investigational agent(s)
The following steps will be taken to report promptly and document accurately any SAE, even if it 
may not appear to be related to the study treatment:

Report the SAE to the PI and the treating physician by email, telephone or fax 
within 24 hours of becoming aware that a patient has experienced an SAE.

Record the SAE accurately on the AE page of the patient’s CRF.

Using the standard IRB-SAE report form, submit all known patient information 
within 24 hours of SAE occurrence to the clinical trial office to submit to IRB 
and DSMB. Date and sign each report before submission. Include the following 
information (or as much as possible to obtain and still report the event within 
24 hours): 

Study protocol number and indication

Study site and investigator’s identification

Patient’s ID (patient number and initials), age or date of birth, and sex

Date of enrollment

Description of SAE, including date of onset and duration, severity, and outcome

Date of first and most recent (last) dose administered

Action taken regarding study treatment

Relationship of SAE to study treatment

Concomitant medications, including regimen and indication

Intervention, including concomitant medications used to treat SAE

Pertinent laboratory data/diagnostic tests conducted and date

Pertinent medical history of patient

Date of hospital admission/discharge

Date of death (if applicable)
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Within 10 days of initial IRB notification, the PI is required to submit a completed Adverse Event 
Report to the IRB.  The treating physicians should perform appropriate diagnostic tests and 
therapeutic measures and submit all follow-up substantiating data, such as diagnostic test reports 
and autopsy report to the PI, IRB, and DSMB.
12.3.2 Death and Immediately Life-Threatening Events 
Any death and immediately life-threatening event from any cause while a patient is receiving trial 
treatment on this protocol or up to 30 days after the last dose of trial treatment, or any death and 
immediately life-threatening event occurring more than 30 days after trial treatment has ended but 
which is felt to be treatment related must be reported within 24 hours of discovery of the event.  
All deaths must be reported primarily for the purposes of SAE reporting; however, deaths due 
unequivocally to progression are not SAEs.  The primary investigator, IRB and DSMB should be 
notified and their reporting procedure followed.
13
References
1.
Torre, L.A., et al., Global cancer statistics, 2012. CA Cancer J Clin, 2015. 65(2): p. 87-108.
2.
Scher, H.I. and C.L. Sawyers, Biology of progressive, castration-resistant prostate cancer: 
directed therapies targeting the androgen-receptor signaling axis. J Clin Oncol, 2005. 
23(32): p. 8253-61.
3.
de Bono, J.S., et al., Abiraterone and increased survival in metastatic prostate cancer. N 
Engl J Med, 2011. 364(21): p. 1995-2005.
4.
Ryan, C.J., et al., Abiraterone in metastatic prostate cancer without previous 
chemotherapy. N Engl J Med, 2013. 368(2): p. 138-48.
5.
Fizazi, K., et al., Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate 
Cancer. N Engl J Med, 2017. 377(4): p. 352-360.
6.
James, N.D., et al., Abiraterone for Prostate Cancer Not Previously Treated with Hormone 
Therapy. N Engl J Med, 2017. 377(4): p. 338-351.
7.
Barrie, S.E., et al., Pharmacology of novel steroidal inhibitors of cytochrome P450(17) 
alpha (17 alpha-hydroxylase/C17-20 lyase). J Steroid Biochem Mol Biol, 1994. 50(5-6): p. 
267-73.
8.
O'Donnell, A., et al., Hormonal impact of the 17alpha-hydroxylase/C(17,20)-lyase inhibitor 
abiraterone acetate (CB7630) in patients with prostate cancer. Br J Cancer, 2004. 90(12): 
p. 2317-25.
9.
Planas, J., et al., Hormonal response recovery after long-term androgen deprivation 
therapy in patients with prostate cancer. Scand J Urol, 2016. 50(6): p. 425-428.
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10.
Bong, G.W., et al., Serum testosterone recovery after cessation of long-term luteinizing 
hormone-releasing hormone agonist in patients with prostate cancer. Urology, 2008. 
71(6): p. 1177-80.
11.
Kaku, H., et al., Time course of serum testosterone and luteinizing hormone levels after 
cessation of long-term luteinizing hormone-releasing hormone agonist treatment in 
patients with prostate cancer. Prostate, 2006. 66(4): p. 439-44.
12.
Scher, H.I., et al., Trial Design and Objectives for Castration-Resistant Prostate Cancer: 
Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3. J 
Clin Oncol, 2016. 34(12): p. 1402-18.
14.
Appendices
14.1 Eligibility Checklist
Inclusion Criteria
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1) The patient must be able to provide study-specific informed consent prior to study entry 
Yes/No
2) Age ≥ 18
Yes/No
3) ECOG Performance Status 0-2
Yes/No
4) Pathologically proven diagnosis of prostate adenocarcinoma 
Yes/No
5) Patients must have metastatic prostate cancer
Yes/No
6) Patients may have mCRPC or may have metastatic castration-sensitive disease. Yes/No
7) Patients must be maintained on a GnRH analogue (agonist (leuprolide, goserelin, triptorelin, 
histerelin, deslorin) or antagonist (degarelix)) 
Yes/No
8) The patient and the investigator have decided that the next line of cancer therapy will be 
abiraterone plus prednisone and the initial dose of abiraterone will be 1000 mg daily. Or 
patients may already be on abiraterone with prednisone at a dose of 1000 mg daily along with 
a GnRH analogue. 
Yes/No
9) Lab values meeting the following criteria 
Yes/No
a) Total testosterone level of <50 ng/dl
b) Total bilirubin < 2.0 X Upper Limit of Normal (ULN)
c) Aspartate aminotransferase (AST) ≤ 3 X ULN
d) Alanine aminotransferase (ALT ) ≤  3 X ULN 
e) Absolute Neutrophil Count > 1.5 K/mm3
f)
Platelets > 100 K/mm3 
g) Hemoglobin ≥9.0 g/dL
h) calculated creatinine clearance ≥ 30 mL/min according to the following formula
Exclusion Criteria
10) History of bilateral orchiectomy
Yes/No
11) History of hypopituitarism
Yes/No
Yes/No
12) For patient not yet started on abiraterone with prednisone, uncontrolled hypertension (systolic 
blood pressure >170 mm Hg or diastolic blood pressure >100 mm Hg) Yes/No
(140 - age) x wt (kg)
72 x creatinine (mg/dl)
Calculated creatinine clearance =
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13) Patients must not have New York Heart Association Class III or IV heart failure at the time of 
screening. Patients must not have any unstable angina, myocardial infarction, or serious 
uncontrolled cardiac arrhythmia within 6 months prior to registration
Yes/No
14) Any other serious illness or medical condition that the principal investigator feels would make the 
patient a poor candidate for this study
Yes/No
14.2
Pill Log
Patient ID __________  Patient Initials ___________ Month ____________ Year____________
Take abiraterone once daily on an empty stomach. While taking abiraterone you must continue 
taking prednisone.  If you have forgotten a dose and it is less than 12 hours until the next dose, you 
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should skip the missed.  Please call your study doctor at (718)405-8505 if you experience any side 
effects or if you have any concerns or questions. Remember to bring this pill diary to each study 
visit.
Day
Date
Time
Number of 250 mg 
tablets taken
Comments
1
Abiraterone
2
Abiraterone
3
Abiraterone
4
Abiraterone
5
Abiraterone
6
Abiraterone
7
Abiraterone
8
Abiraterone
9
Abiraterone
10
Abiraterone
11
Abiraterone
12
Abiraterone
13
Abiraterone
14
Abiraterone
15
Abiraterone
16
Abiraterone
17
Abiraterone
18
Abiraterone
19
Abiraterone
20
Abiraterone
21
Abiraterone
22
Abiraterone
23
Abiraterone
24
Abiraterone
25
Abiraterone
26
Abiraterone
27
Abiraterone
28
Abiraterone
29
Abiraterone
30
Abiraterone
31
Abiraterone
Patient Signature __________________________   Date _______________________
Research Staff Signature __________________________   Date _______________________
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IRB APPROVAL DATE: 01/27/2025