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NCT05422911 · ClinicalTrials.gov record · last posted 2026-06-15

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

StatusRecruiting
PhasePhase 2
Started2022-08-31
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 2 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 2 times since 2022-06-13; most recent amendment 2026-06-10. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2026-06-10
Status change Not Yet RecruitingRecruitingv2
Trial Details
NCT Number NCT05422911
Lead Sponsor Sun Pharmaceutical Industries Limited
Collaborators: VA Puget Sound Health Care System, VA Greater Los Angeles Healthcare System, James A. Haley Veterans Administration Hospital, VA New York Harbor Healthcare System, VA Ann Arbor Healthcare System, Corporal Michael J. Crescenz VA Medical Center, W.G. Bill Hefner Medical Center, Portland VA Medical Center, Michael E. DeBakey VA Medical Center, VA St. Louis Health Care System, VA Hudson Valley HealthCare System
Conditions Metastatic Cancer, Neoplasm, Prostate, Castrate-sensitive, Castrate-sensitive Prostate Cancer
Enrollment 192 participants
Start Date 2022-08-31
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-15