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

NCT ID: NCT03565835

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-13
• Study Completion Date: 2021-11-17

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Abiraterone and Prednisone without a GnRH Analogue

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

Group Type: EXPERIMENTAL

Abiraterone Acetate

Intervention Type: DRUG

Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue

Prednisone

Intervention Type: DRUG

Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue

Interventions

Abiraterone Acetate

Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue

Intervention Type: DRUG

Prednisone

Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• Hemoglobin ≥ 9.0 g/dL
• Calculated creatinine clearance ≥ 30 mL/min

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Gartrell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Gartrell, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

References

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2017-8506

Identifier Type: -

Identifier Source: org_study_id