Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer

This phase II trial compares the effects, good and/or bad of abiraterone and prednisone or darolutamide alone in treating patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Androgens (male hormones) can cause the growth of prostate tumor cells. Abiraterone acetate lowers the amount of androgens made by the body. This may help stop the growth of prostate tumor cells that need androgen to grow. Darolutamide blocks the use of androgens by the tumor cells. Prednisone is used to lessen inflammation and lower the body's immune response. Researchers want to compare the side effects of standard of care (SOC) abiraterone and prednisone or darolutamide alone in treating patients with advanced prostate cancer.

NCT Number	NCT06173362
Lead Sponsor	University of California, Davis Collaborators: National Cancer Institute (NCI)
Conditions	Advanced Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
Enrollment	75 participants
Start Date	2023-11-09
Primary Completion	2026-11 (estimated)
Study Completion	2027-05 (estimated)
Updated on ClinicalTrials.gov	2026-03-13