Prostatic NeoplasmsPhase 2NCT03565835

Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer

A Phase 2 study testing Abiraterone Acetate and Prednisone in people with Prostatic Neoplasms, run by Montefiore Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostatic Neoplasms
What is being tested?: Abiraterone Acetate and Prednisone
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 13 Jun 2018to 17 Nov 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

The patient must be able to provide study-specific informed consent prior to study entry
Age ≥ 18
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Pathologically proven diagnosis of prostate adenocarcinoma
Patients must have metastatic prostate cancer
Patients may have mCRPC or may have metastatic castration-sensitive disease.

Show all 17Show fewer

Patients must be maintained on a GnRH analogue (agonist (leuprolide, goserelin, triptorelin, histrelin, deslorelin) or antagonist (degarelix))
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.
Lab values meeting the following criteria
Total testosterone level of <50 ng/dl
Total bilirubin < 2.0 X Upper Limit of Normal (ULN)
Aspartate aminotransferase (AST) ≤ 3 X ULN
Alanine aminotransferase (ALT) ≤ 3 X ULN
Absolute Neutrophil Count > 1.5 K/mm3
Platelets > 100 K/mm3
Hemoglobin ≥ 9.0 g/dL
Calculated creatinine clearance ≥ 30 mL/min

Who cannot join

History of bilateral orchiectomy
History of hypopituitarism
For patients not yet started on abiraterone with prednisone, uncontrolled hypertension (systolic blood pressure >170 mm Hg or diastolic blood pressure >100 mm Hg)
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
Any other serious illness or medical condition that the principal investigator feels would make the patient a poor candidate for this study

Trial locations and contacts

1 site in 1 country.

United States1 site

Montefiore Medical Center
The Bronx, New York, 10461

Other trials in United States

About this study

The goal of this study is to find out if patients with prostate cancer being treated with the medications abiraterone and prednisone can discontinue hormone injections (examples include leuprolide, goserelin, triptorelin and degarelix). Abiraterone and prednisone are pills used to treat patients with prostate cancer. When abiraterone and prednisone are used, hormone injections are usually continued to maintain a low testosterone level in the blood. This study is being done to find out if testosterone in the blood will stay low while abiraterone and prednisone are used without continued hormone injections.

Read the detailed description

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 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.

Conditions: Prostatic Neoplasms
Being tested: Abiraterone Acetate, Prednisone
Keywords: abiraterone, prostate cancer, androgen deprivation therapy
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Abiraterone AcetateDrug
Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue
PrednisoneDrug
Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue

Study groups in NCT03565835
Study group	Role	What they receive
Abiraterone and Prednisone without a GnRH Analogue	Experimental	Abiraterone (1000 mg daily) with Prednisone (5 mg) with Discontinuation of GnRH Analogue Injection Receives: Drug: Abiraterone Acetate; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients With Castrate Level of Serum Testosterone
The number/percentage of patients with a castrate serum testosterone level, defined as having a serum castrate concentration <50 ng/dL when Abiraterone acetate plus prednisone (AAP) is used without GnRH analogues in metastatic prostate cancer, will be determined. Results are summarized as a number/percentage of participants.
Measured: Approximately 24 weeks

Secondary outcomes (6)

Serum Testosterone (T) Levels
Mean serum testosterone (T) concentrations in patients with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue was measured. Results have been summarized and reported in nanograms/deciliter (ng/dL) using basic descriptive statistics.
Measured: Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment
Serum Luteinizing Hormone (LH) Levels
Mean serum LH levels in patients with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue was measured. Results have been summarized and reported in International Units/Liter (IU/L) using basic descriptive statistics.
Measured: Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment
Prostate-specific Antigen (PSA) Response
Mean PSA response in patients with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue was measured. Results have been summarized and reported in ng/mL using basic descriptive statistics.
Measured: Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment
Treatment-related Adverse Events Due to Toxicity
The number of patients with treatment-related adverse events due to toxicity which lead to discontinuation from the study at 24 weeks is summarized.
Measured: 24 weeks
Radiographic Progression-free Survival (rPFS)
The duration of time from trial entry until radiographic progression-free survival will be measured/reported. Progression-free survival is an assessment of the average time a patient lives without disease progression, as detected on radiographic imaging scans, or the patient dies from the disease, whichever comes first. Results have been summarized and reported in weeks using basic descriptive statistics.
Measured: From initiation of treatment to the end of treatment, up to approximately 41 months (~178 weeks)
Overall Survival (OS)
Overall survival is an assessment of survival from the time initiation of treatment until the time of death to death due to any cause. Results have been summarized and reported in weeks using basic descriptive statistics.
Measured: From initiation of treatment until the end of treatment, up to approximately 41 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 201817 Nov 2021

First posted21 Jun 2018
Study start13 Jun 2018
Primary completion17 Nov 2021
Study completion17 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03565835
Sponsor's protocol ID: 2017-8506
Status last verified: Jan 2026
First submitted: 29 May 2018
Last updated: 26 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
PubMed 25651787
Scher HI, Sawyers CL. Biology of progressive, castration-resistant prostate cancer: directed therapies targeting the androgen-receptor signaling axis. J Clin Oncol. 2005 Nov 10;23(32):8253-61. doi: 10.1200/JCO.2005.03.4777.
PubMed 16278481
Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, Ozguroglu M, Ye D, Feyerabend S, Protheroe A, De Porre P, Kheoh T, Park YC, Todd MB, Chi KN; LATITUDE Investigators. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2017 Jul 27;377(4):352-360. doi: 10.1056/NEJMoa1704174. Epub 2017 Jun 4.
PubMed 28578607
James ND, de Bono JS, Spears MR, Clarke NW, Mason MD, Dearnaley DP, Ritchie AWS, Amos CL, Gilson C, Jones RJ, Matheson D, Millman R, Attard G, Chowdhury S, Cross WR, Gillessen S, Parker CC, Russell JM, Berthold DR, Brawley C, Adab F, Aung S, Birtle AJ, Bowen J, Brock S, Chakraborti P, Ferguson C, Gale J, Gray E, Hingorani M, Hoskin PJ, Lester JF, Malik ZI, McKinna F, McPhail N, Money-Kyrle J, O'Sullivan J, Parikh O, Protheroe A, Robinson A, Srihari NN, Thomas C, Wagstaff J, Wylie J, Zarkar A, Parmar MKB, Sydes MR; STAMPEDE Investigators. Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy. N Engl J Med. 2017 Jul 27;377(4):338-351. doi: 10.1056/NEJMoa1702900. Epub 2017 Jun 3.
PubMed 28578639
Barrie SE, Potter GA, Goddard PM, Haynes BP, Dowsett M, Jarman M. Pharmacology of novel steroidal inhibitors of cytochrome P450(17) alpha (17 alpha-hydroxylase/C17-20 lyase). J Steroid Biochem Mol Biol. 1994 Sep;50(5-6):267-73. doi: 10.1016/0960-0760(94)90131-7.
PubMed 7918112
O'Donnell A, Judson I, Dowsett M, Raynaud F, Dearnaley D, Mason M, Harland S, Robbins A, Halbert G, Nutley B, Jarman M. Hormonal impact of the 17alpha-hydroxylase/C(17,20)-lyase inhibitor abiraterone acetate (CB7630) in patients with prostate cancer. Br J Cancer. 2004 Jun 14;90(12):2317-25. doi: 10.1038/sj.bjc.6601879.
PubMed 15150570
Planas J, Celma A, Placer J, Cuadras M, Regis L, Gasanz C, Trilla E, Salvador C, Lorente D, Morote J. Hormonal response recovery after long-term androgen deprivation therapy in patients with prostate cancer. Scand J Urol. 2016 Dec;50(6):425-428. doi: 10.1080/21681805.2016.1227876. Epub 2016 Sep 14.
PubMed 27628623
de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Flechon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. doi: 10.1056/NEJMoa1014618.
PubMed 21612468
Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. doi: 10.1056/NEJMoa1209096. Epub 2012 Dec 10.
PubMed 23228172
Bong GW, Clarke HS Jr, Hancock WC, Keane TE. Serum testosterone recovery after cessation of long-term luteinizing hormone-releasing hormone agonist in patients with prostate cancer. Urology. 2008 Jun;71(6):1177-80. doi: 10.1016/j.urology.2007.09.066. Epub 2008 Feb 15.
PubMed 18279929
Kaku H, Saika T, Tsushima T, Ebara S, Senoh T, Yamato T, Nasu Y, Kumon H. 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 Mar 1;66(4):439-44. doi: 10.1002/pros.20341.
PubMed 16329145
Scher HI, Morris MJ, Stadler WM, Higano C, Basch E, Fizazi K, Antonarakis ES, Beer TM, Carducci MA, Chi KN, Corn PG, de Bono JS, Dreicer R, George DJ, Heath EI, Hussain M, Kelly WK, Liu G, Logothetis C, Nanus D, Stein MN, Rathkopf DE, Slovin SF, Ryan CJ, Sartor O, Small EJ, Smith MR, Sternberg CN, Taplin ME, Wilding G, Nelson PS, Schwartz LH, Halabi S, Kantoff PW, Armstrong AJ; Prostate Cancer Clinical Trials Working Group 3. Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3. J Clin Oncol. 2016 Apr 20;34(12):1402-18. doi: 10.1200/JCO.2015.64.2702. Epub 2016 Feb 22.
PubMed 26903579

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
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All Prostatic Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer
ClinicalTrials.gov ID: NCT03565835
Acronym / sponsor ID: 2017-8506
Conditions: Prostatic Neoplasms
Keywords: abiraterone, prostate cancer, androgen deprivation therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Montefiore Medical CenterUniversity, hospital or other
Study start: 13 Jun 2018 (actual)
Primary completion: 17 Nov 2021 (actual)
Study completion: 17 Nov 2021 (actual)
First posted: 21 Jun 2018 (actual)
Results: Posted 26 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Abiraterone and Prednisone without a GnRH Analogue	Experimental	Drug: Abiraterone Acetate, Drug: PrednisoneAbiraterone (1000 mg daily) with Prednisone (5 mg) with Discontinuation of GnRH Analogue Injection

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

The patient must be able to provide study-specific informed consent prior to study entry
Age ≥ 18
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Pathologically proven diagnosis of prostate adenocarcinoma
Patients must have metastatic prostate cancer

Key exclusion criteria (5 listed)

History of bilateral orchiectomy
History of hypopituitarism
For patients not yet started on abiraterone with prednisone, uncontrolled hypertension (systolic blood pressure >170 mm Hg or diastolic blood pressure >100 mm Hg)
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
Any other serious illness or medical condition that the principal investigator feels would make the patient a poor candidate for this study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Abiraterone AcetateAbiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue	Drug	Abiraterone and Prednisone without a GnRH Analogue
PrednisoneAbiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue	Drug	Abiraterone and Prednisone without a GnRH Analogue

Primary outcome

Percentage of Patients With Castrate Level of Serum Testosterone
Time frame: Approximately 24 weeks
The number/percentage of patients with a castrate serum testosterone level, defined as having a serum castrate concentration <50 ng/dL when Abiraterone acetate plus prednisone (AAP) is used without GnRH analogues in metastatic prostate cancer, will be determined. Results are summarized as a number/percentage of participants.

6 secondary outcomes

Serum Testosterone (T) Levels
Time frame: Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment
Serum Luteinizing Hormone (LH) Levels
Time frame: Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment
Prostate-specific Antigen (PSA) Response
Time frame: Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment
Treatment-related Adverse Events Due to Toxicity
Time frame: 24 weeks
Radiographic Progression-free Survival (rPFS)
Time frame: From initiation of treatment to the end of treatment, up to approximately 41 months (~178 weeks)
Overall Survival (OS)
Time frame: From initiation of treatment until the end of treatment, up to approximately 41 months

Results and safety

Results posted to the registry on 26 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Abiraterone and Prednisone Without a GnRH Analogue	31	27

Primary outcome: Percentage of Patients With Castrate Level of Serum Testosterone

Time frame: Approximately 24 weeks. Count of participants. Unit: Participants

Measure	Abiraterone and Prednisone Without a GnRH Analogue n = 27
Value	25

Population analysed: 27 of 31 patients were evaluable at \~24 weeks

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) will be recorded from the time of consent and for at least 30 days after treatment discontinuation, up to 41 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Abiraterone and Prednisone Without a GnRH Analogue	0 of 31 (0%)	16 of 31 (51.6%)	3 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25651787Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
Background: PubMed 16278481Scher HI, Sawyers CL. Biology of progressive, castration-resistant prostate cancer: directed therapies targeting the androgen-receptor signaling axis. J Clin Oncol. 2005 Nov 10;23(32):8253-61. doi: 10.1200/JCO.2005.03.4777.
Background: PubMed 28578607Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, Ozguroglu M, Ye D, Feyerabend S, Protheroe A, De Porre P, Kheoh T, Park YC, Todd MB, Chi KN; LATITUDE Investigators. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2017 Jul 27;377(4):352-360. doi: 10.1056/NEJMoa1704174. Epub 2017 Jun 4.
Background: PubMed 28578639James ND, de Bono JS, Spears MR, Clarke NW, Mason MD, Dearnaley DP, Ritchie AWS, Amos CL, Gilson C, Jones RJ, Matheson D, Millman R, Attard G, Chowdhury S, Cross WR, Gillessen S, Parker CC, Russell JM, Berthold DR, Brawley C, Adab F, Aung S, Birtle AJ, Bowen J, Brock S, Chakraborti P, Ferguson C, Gale J, Gray E, Hingorani M, Hoskin PJ, Lester JF, Malik ZI, McKinna F, McPhail N, Money-Kyrle J, O'Sullivan J, Parikh O, Protheroe A, Robinson A, Srihari NN, Thomas C, Wagstaff J, Wylie J, Zarkar A, Parmar MKB, Sydes MR; STAMPEDE Investigators. Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy. N Engl J Med. 2017 Jul 27;377(4):338-351. doi: 10.1056/NEJMoa1702900. Epub 2017 Jun 3.
Background: PubMed 7918112Barrie SE, Potter GA, Goddard PM, Haynes BP, Dowsett M, Jarman M. Pharmacology of novel steroidal inhibitors of cytochrome P450(17) alpha (17 alpha-hydroxylase/C17-20 lyase). J Steroid Biochem Mol Biol. 1994 Sep;50(5-6):267-73. doi: 10.1016/0960-0760(94)90131-7.
Background: PubMed 15150570O'Donnell A, Judson I, Dowsett M, Raynaud F, Dearnaley D, Mason M, Harland S, Robbins A, Halbert G, Nutley B, Jarman M. Hormonal impact of the 17alpha-hydroxylase/C(17,20)-lyase inhibitor abiraterone acetate (CB7630) in patients with prostate cancer. Br J Cancer. 2004 Jun 14;90(12):2317-25. doi: 10.1038/sj.bjc.6601879.
Background: PubMed 27628623Planas J, Celma A, Placer J, Cuadras M, Regis L, Gasanz C, Trilla E, Salvador C, Lorente D, Morote J. Hormonal response recovery after long-term androgen deprivation therapy in patients with prostate cancer. Scand J Urol. 2016 Dec;50(6):425-428. doi: 10.1080/21681805.2016.1227876. Epub 2016 Sep 14.
Background: PubMed 21612468de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Flechon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. doi: 10.1056/NEJMoa1014618.
Background: PubMed 23228172Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. doi: 10.1056/NEJMoa1209096. Epub 2012 Dec 10.
Background: PubMed 18279929Bong GW, Clarke HS Jr, Hancock WC, Keane TE. Serum testosterone recovery after cessation of long-term luteinizing hormone-releasing hormone agonist in patients with prostate cancer. Urology. 2008 Jun;71(6):1177-80. doi: 10.1016/j.urology.2007.09.066. Epub 2008 Feb 15.
Background: PubMed 16329145Kaku H, Saika T, Tsushima T, Ebara S, Senoh T, Yamato T, Nasu Y, Kumon H. 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 Mar 1;66(4):439-44. doi: 10.1002/pros.20341.
Background: PubMed 26903579Scher HI, Morris MJ, Stadler WM, Higano C, Basch E, Fizazi K, Antonarakis ES, Beer TM, Carducci MA, Chi KN, Corn PG, de Bono JS, Dreicer R, George DJ, Heath EI, Hussain M, Kelly WK, Liu G, Logothetis C, Nanus D, Stein MN, Rathkopf DE, Slovin SF, Ryan CJ, Sartor O, Small EJ, Smith MR, Sternberg CN, Taplin ME, Wilding G, Nelson PS, Schwartz LH, Halabi S, Kantoff PW, Armstrong AJ; Prostate Cancer Clinical Trials Working Group 3. Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3. J Clin Oncol. 2016 Apr 20;34(12):1402-18. doi: 10.1200/JCO.2015.64.2702. Epub 2016 Feb 22.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Benjamin Gartrell, MD principal investigator

Montefiore Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone Acetate and Prednisone in people with Prostatic Neoplasms, run by Montefiore Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Castrate Level of Serum Testosterone (time frame: Approximately 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03565835, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.