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

NCT03565835 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2017-8506
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostatic Neoplasms

Keywords

abiraterone; prostate cancer; androgen deprivation therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Approximately 24 weeks

Secondary Outcomes (6)

• Serum Testosterone (T) Levels

  Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment

• Serum Luteinizing Hormone (LH) Levels

  Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment

• Prostate-specific Antigen (PSA) Response

  Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment

• Treatment-related Adverse Events Due to Toxicity

  24 weeks

• Radiographic Progression-free Survival (rPFS)

  From initiation of treatment to the end of treatment, up to approximately 41 months (~178 weeks)

Study Arms (1)

Abiraterone and Prednisone without a GnRH Analogue

EXPERIMENTAL

Abiraterone (1000 mg daily) with Prednisone (5 mg) with Discontinuation of GnRH Analogue Injection

Drug: Abiraterone Acetate; Drug: Prednisone

Interventions

Abiraterone Acetate DRUG

Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue

Abiraterone and Prednisone without a GnRH Analogue

Prednisone DRUG

Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue

Abiraterone and Prednisone without a GnRH Analogue

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (12)

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  PMID: 16278481 BACKGROUND

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  PMID: 28578607 BACKGROUND

• 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.

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• 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.

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  PMID: 15150570 BACKGROUND

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  PMID: 27628623 BACKGROUND

• 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.

  PMID: 21612468 BACKGROUND

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  PMID: 26903579 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes

Results Point of Contact

• Title: Dr. Benjamin Gartrell
• Organization: Montefiore Medical Center

bgartrel@montefiore.org

718-405-8404

Study Officials

• Benjamin Gartrell, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 21, 2018
• Study Start: June 13, 2018
• Primary Completion: November 17, 2021
• Study Completion: November 17, 2021
• Last Updated: January 26, 2026
• Results First Posted: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)