Phase II Study Comparing Abiraterone with Prednisone Versus Darolutamide for Treating Advanced Prostate Cancer

What this Trial Is About

Researchers are evaluating the effects and side effects of two treatments, abiraterone with prednisone and darolutamide alone, in men with advanced prostate cancer that has spread beyond the prostate. This phase II trial aims to assess how well patients tolerate these treatments and compares their impact on prostate tumor growth driven by male hormones. The study also looks at prostate-specific antigen PSA response over seven months to understand treatment effects better. Participants are assigned to one of two groups based on their doctors preference. One group receives abiraterone and prednisone following standard care guidelines, and the other group receives darolutamide alone. Treatments continue for up to one year, provided there is no disease progression or unacceptable side effects. Blood samples are collected during screening and throughout the study to monitor patients. After completing treatment, patients are followed for up to three years to observe long-term outcomes. Throughout the study, researchers monitor for serious side effects, particularly those that are grade 3 or higher, at the 12-month mark. Participants health is regularly assessed, including their ability to continue treatment and adherence to study visits. This careful monitoring helps evaluate the safety and tolerability of these therapies over time.

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