Phase 2 Randomized Study Comparing Abiraterone Acetate, Enzalutamide, and Apalutamide as First Treatment in Veterans With Castrate-Sensitive Prostate Cancer

What this Trial Is About

Researchers are studying treatment options for Veterans with castrate-sensitive prostate cancer, a type of metastatic prostate cancer. This phase 2 randomized trial compares three drugs abiraterone acetate, enzalutamide, and apalutamide, to explore their effects on tumor growth and testosterone levels over two years. The study aims to build on previous findings showing uniform and high-quality care for Veterans in the Veterans Health Administration system, focusing on personalized treatment approaches and molecular differences among participants. Participants receive one of the three oral drugs daily in combination with a gonadotropin-releasing hormone GnRH agonist or antagonist, unless they have had prior surgical castration. The abiraterone acetate group may receive either YONSA or ZYTIGA formulations with corticosteroids, while the enzalutamide and apalutamide groups take their respective tablets once daily. Treatment continues as per the study protocol with careful monitoring. During the study, participants will undergo regular assessments including measuring tumor growth rate, testosterone levels, and prostate-specific antigen PSA response over two years. Safety labs like liver and kidney function tests, blood counts, and potassium levels will be monitored. The study evaluates how these treatments affect prostate cancer progression and hormone levels, with follow-up until study completion at the end of 2027.

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