3-arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients With Prostate Cancer With a Rising PSA or a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy

• Status: Completed
• Trial end date: 2020-09-28

Summary

In April 2011, the United States Food and Drug Administration (FDA) approved the oral drug abiraterone acetate (Zytiga ®) in combination with prednisone (a steroid) to treat patients with metastatic castration-resistant prostate cancer who have received prior docetaxel (chemotherapy). In December 2012, the FDA approved Zytiga ® in combination with prednisone to treat patients with metastatic castration-resistant prostate cancer who have not received prior chemotherapy. Degarelix (Firmagon ®), a testosterone lowering agent given as a monthly injection, is FDA approved for the treatment of patients with advanced prostate cancer. The purpose of this study is to evaluate abiraterone acetate and prednisone in combination with degarelix as a possible treatment for PSA recurrent prostate cancer as compared to abiraterone acetate alone and degarelix alone. This will be the first time these drugs will be used together.

• Phase: Phase 2

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Duke University; Feinberg School of Medicine, Northwestern University; Ferring Pharmaceuticals; GU Research Network, LLC; Janssen Scientific Affairs, LLC; NorthShore University HealthSystem; OHSU Knight Cancer Institute; Perlmutter New York University Cancer Center; Rutgers Cancer Institute of New Jersey; Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; University of California, Los Angeles; University of North Carolina; Wayne State University; Weill Medical College of Cornell University
• Treatments: Abiraterone Acetate; Prednisone