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

Metastatic Cancer Clinical Trial

Official title: A Phase 2 Randomized Study of YONSA® (Abiraterone Acetate), Enzalutamide or Apalutamide as First Line Therapy in Veterans With Castrate-sensitive Prostate Cancer

Status Not yet recruiting

Clinical Trial Summary

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, uniform across the US and indifferent to race. 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, African Americans with prostate cancer fared as well if not better than Caucasians and importantly had better outcomes with abiraterone, an observation needing further exploration as these therapies move up front.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm, Prostate
• Prostatic Neoplasms

• NCT number: NCT05422911
• Study type: Interventional
• Source: James J. Peters Veterans Affairs Medical Center
• Contact: Tito Fojo, MD, PhD
• Phone: 718-584-9000
• Email: antonio.fojo@va.gov
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 30, 2022
• Completion date: June 30, 2026