“A phase 2 randomized study of abiraterone acetate, enzalutamide or apalutamide as first line therapy in Veterans with castrate-sensitive prostate cancer”, is a research trial funded by the Prostate Cancer Foundation. This trial was designed for veterans who are newly diagnosed with prostate cancer that is considered aggressive (likely to get larger or spread to other parts of the body); this is also known as metastatic prostate cancer.

Three oral medications that are approved by the Food & Drug Administration (FDA) for the treatment of prostate cancer are abiraterone acetate, enzalutamide, and apalutamide. This trial aims to collect information on the safety and effectiveness of taking YONSA® (abiraterone acetate) as the first medication to treat prostate cancer, in comparison to taking enzalutamide or apalutamide first.

To collect this information, this trial will consist of two veteran cohorts (groups), “African American Veterans” or “other than African American Veterans”. Participants within each veteran cohort will be randomly assigned (by chance) to one of three study groups: YONSA® (abiraterone acetate), generic ZYTIGA (abiraterone acetate), or physician’s choice of enzalutamide or apalutamide. There is a 2:1 chance (higher likelihood) of randomization to abiraterone acetate [66% chance] as opposed to the enzalutamide or apalutamide group [33% chance]. Randomization will continue until 64 Veterans randomly assigned to abiraterone acetate have been enrolled to the slowest accruing cohort.

The national co-Principal Investigators for this trial are Dr. Antonio Tito Fojo, M.D. and Dr. Susan E. Bates, M.D. from the James J. Peters Veterans Affairs Medical Center (JJP VAMC). Study enrollment initially began at the JJP VAMC in 2022 as a pilot program. In 2024, study participation will include an additional 11 VAMCs across the nation. Enrollment in this study is projected to last two years and the overall study is expected to be completed in approximately 4 years. Possible benefits of this trial may include positive cancer response to treatment with any of the study drugs, and the information from this study may help future patients with metastatic prostate cancer. It may also help researchers understand whether abiraterone acetate leads to better outcomes in African Americans.