Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.

June 10, 2026 updated by: Sun Pharmaceutical Industries Limited

A Phase 2 Randomized Study of Abiraterone Acetate, Enzalutamide or Apalutamide as First Line Therapy in Veterans With Castrate-sensitive Prostate Cancer

The investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC. In the real-world that is the VHA, the investigators have successfully estimated g values that accurately predict OS and the use of this metric in other settings should now be explored. In the egalitarian system that is the VHA the treatment of prostate cancer is excellent and uniform across the US. The choices made are clearly personalized, given not all men received all therapies and that younger Veterans were treated more aggressively.

But with survivals that rival those in registration trials that enroll optimally fit individuals usually not encumbered by the co-morbidities that afflict many Veterans, the outcomes are testimony to the fact that for this common malady of older Veterans with whom VA physicians have broad experience the care administered is unsurpassed. Importantly this care at least as regards Veterans with mCRPC demonstrates that given equal access to health care, all men with prostate cancer fare comparably well. As our sophistication in categorizing cancers molecularly has increased this study will look to better examine any emerging differences across study participants.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

192

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 Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90073
    • Florida
      • Tampa, Florida, United States, 33612
    • Michigan
    • Missouri
    • New York
    • North Carolina
    • Oregon
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Texas
      • Houston, Texas, United States, 77030
    • Washington

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Veterans must meet the following to be eligible to participate:
  • Be willing and able to provide written informed consent for the trial.
  • Age ≥18 years of age on day of signing informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (on a scale from 0 to 5, with higher scores indicating greater disability and a score of 5 indicating death).
  • Histologically or cytologically confirmed adenocarcinoma of the prostate without morphologic evidence of small-cell features in either a recently obtained sample or in the archival sample at the time of diagnosis.
  • Have previously begun within 120 days of randomization or will receive androgen-deprivation therapy with a gonadotropin releasing hormone agonist or antagonist or have undergone bilateral orchiectomy (i.e., medical, or surgical castration).

  • Laboratory tests meet minimum safety requirements:

    • Hepatic: AST ≤2.5 X institutional ULN, ALT ≤2.5 X institutional ULN, Total bilirubin ≤1.5X upper limit of normal (ULN) [except for subjects with documented Gilbert's disease in which case total bilirubin not to exceed 10X ULN].
    • Renal: Creatinine clearance ≥30 ml/min or serum creatinine ≤1.8 mg/dl
    • Hematological: Platelet count ≥100,000/mm^3; Hemoglobin >9 g/dL; ANC >1 X10^9/L
    • Serum potassium >3 mEq/L

Exclusion Criteria:

Subjects with any of the following will not be enrolled:

  • Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, apalutamide or enzalutamide or darolutamide for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo).
  • Treatment with hormonal therapy (e.g., androgen receptor inhibitors other than bicalutamide, estrogens, 5-alpha reductase inhibitors) or biologic therapy for prostate cancer (other than approved bone-targeting agents and GnRH agonist/antagonist therapy) within 4 weeks of randomization.
  • History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma).
  • Patients who are receiving any other investigational agents concurrently.
  • Clinically significant heart disease as evidenced by New York Heart Association (NYHA) Class III-IV heart disease.
  • Child-Pugh Class B and C

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care
Drug: Apalutamide
Apalutamide (ERLEADA®), 240 mg (four 60 mg tablets) administered orally once daily + physician's choice GnRH agonist/antagonist [unless the Veteran has had prior bilateral orchiectomy].
Other Names:
  • ERLEADA®
Drug: Enzalutamide
Enzalutamide (XTANDI®), 160 mg (four 40 mg capsules) administered orally once daily + physician's choice GnRH agonist/antagonist [unless the Veteran has had prior bilateral orchiectomy].
Other Names:
  • XTANDI®
Active Comparator: Abiraterone Acetate
Drug: Abiraterone acetate

YONSA® (fine particle formulation abiraterone acetate), YONSA® 500 mg (four 125 mg tablets) or 625 mg (five 125 mg tablets) administered orally once daily in combination with methylprednisolone 4 mg administered orally twice daily + physician's choice GnRH agonist/antagonist [unless the Veteran has had prior bilateral orchiectomy]. Note that in the first four months the YONSA® dose should not exceed 500 mg administered orally once daily.

ZYTIGA® (abiraterone acetate) or generic ZYTIGA 1000 mg (four 250 mg uncoated tablets or two 500 mg film-coasted tablets) administered orally once daily in combination with prednisone 5 mg administered orally once daily + physician's choice GnRH agonist/antagonist [unless the Veteran has had prior bilateral orchiectomy].

Other Names:
  • ZYTIGA®
  • YONSA®
  • generic ZYTIGA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor growth rate (g)
Time Frame: 2 years
Tumor growth rate (g)
2 years
Testosterone levels
Time Frame: 2 years
Testosterone levels to assess testosterone suppression with androgen deprivation therapy (ADT).
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSA Response
Time Frame: 2 years
PSA response based Prostate Cancer Working Group 2 guidelines.
2 years

Collaborators and Investigators

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

Sponsor

Sun Pharmaceutical Industries Limited

Collaborators

VA Puget Sound Health Care System
Michael E. DeBakey VA Medical Center
VA New York Harbor Healthcare System
VA Greater Los Angeles Healthcare System
Corporal Michael J. Crescenz VA Medical Center
VA Ann Arbor Healthcare System
Portland VA Medical Center
VA St. Louis Health Care System
James A. Haley Veterans Administration Hospital
W.G. Bill Hefner Medical Center
VA Hudson Valley HealthCare System

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)

August 31, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 9, 2022

First Submitted That Met QC Criteria

June 13, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1641701
  • 21-35 (Other Identifier: VA Central IRB)

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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