A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer

Degarelix is an injection that is approved by the U.S. Food and Drug Administration (FDA) to treat advanced prostate cancer. It is in a class of drugs called gonadotropin-releasing hormone (GnRh) receptor antagonists. It works by decreasing the amount of testosterone (a male hormone) produced by the body. Abiraterone acetate is another type of hormone therapy that is FDA-approved for advanced prostate cancer. Abiraterone acetate works by blocking an enzyme (protein) called cytochrome P17. Abiraterone acetate is a form of androgen deprivation therapy (ADT), or hormone therapy. The goal of ADT is to reduce levels of male hormones, called androgens, in the body, in order to stop them from affecting prostate cancer cells. Prednisone (a corticosteroid) is given with abiraterone acetate to stop or reduce its associated side effects. Though Degarelix and Abiraterone acetate are FDA-approved for use in prostate cancer as single drugs, the combination is still being studied. This means that the combination of the two drugs is investigational and is not FDA-approved in the United States for men with high-risk prostate cancer after surgery. Although ADT is initially effective in lowering PSA, men with advanced prostate cancer often relapse. This study is being done to see if adding an experimental drug called apalutamide, or adding both apalutamide and abiraterone acetate as an experimental drug combination, to Degarelix alone will prevent prostate cancer from relapsing.