Abiraterone/Enzalutamide/Apalutamide for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: James J. Peters Veterans Affairs Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for Veterans with advanced prostate cancer who are at least 18 years old, can consent to the study, have a good performance status (able to carry out daily activities), and haven't received certain other treatments. They should be on hormone therapy but not previously treated with abiraterone, enzalutamide, or apalutamide.

Inclusion Criteria

Predicted life expectancy of >12 months

I am undergoing or will undergo hormone therapy for my cancer.

Laboratory tests meeting minimum safety requirements for hepatic, renal, and hematological parameters

+8 more

Exclusion Criteria

I have a specific type of cancer or condition.

I have had a blood clot in my leg or lung in the last 3 months.

I have a history of seizures or conditions that could lead to seizures.

+3 more

Participant Groups

The trial is testing three medications: Enzalutamide, Apalutamide, and Abiraterone acetate in veterans with castrate-sensitive prostate cancer. It aims to find which drug works best for improving survival without disease progression.

2Treatment groups

Active Control

Group I: Abiraterone AcetateActive Control1 Intervention

Group II: Standard of CareActive Control2 Interventions

Abiraterone acetate is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Zytiga for: