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

January 7, 2026 updated by: Benjamin Gartrell, Montefiore Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Abiraterone and Prednisone without a GnRH Analogue
Abiraterone (1000 mg daily) with Prednisone (5 mg) with Discontinuation of GnRH Analogue Injection
Drug: Abiraterone Acetate
Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue
Drug: Prednisone
Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Testosterone (T) Levels
Time Frame: Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment
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.
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
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.
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
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.
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
The number of patients with treatment-related adverse events due to toxicity which lead to discontinuation from the study at 24 weeks is summarized.
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)
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.
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
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.
From initiation of treatment until the end of treatment, up to approximately 41 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Benjamin Gartrell, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2018

Primary Completion (Actual)

November 17, 2021

Study Completion (Actual)

November 17, 2021

Study Registration Dates

First Submitted

May 29, 2018

First Submitted That Met QC Criteria

June 11, 2018

First Posted (Actual)

June 21, 2018

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-8506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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