🏛️ Verified NIH Record • Updated 2026-06-10

Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer. (NCT05422911)

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

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Sun Pharmaceutical Industries Limited

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (7 items).

Location: VA Greater Los Angeles Healthcare System — Los Angeles, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (12 Sites)

  • VA Greater Los Angeles Healthcare System — Los Angeles, California
  • James A. Haley Veterans Administration Hospital — Tampa, Florida
  • VA Ann Arbor Healthcare System — Ann Arbor, Michigan
  • VA St. Louis Health Care System — St Louis, Missouri
  • VA New York Harbor Healthcare System — New York, New York
  • James J. Peters VA Medical Center — The Bronx, New York
  • VA Hudson Valley Health Care System — Wappingers Falls, New York
  • W.G. Bill Hefner Medical Center — Salisbury, North Carolina
  • VA Portland Health Care System — Portland, Oregon
  • Corporal Michael J. Crescenz VA Medical Center — Philadelphia, Pennsylvania
  • Michael E. DeBakey VA Medical Center — Houston, Texas
  • VA Puget Sound Health Care System — Seattle, Washington

📞 Contact the Study Coordinator

Phone: (718) 584-9000

Email: antonio.fojo@va.gov

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗