Bayer HealthCare announced that it has begun enrolling patients into a Phase 3 trial studying Xofigo (radium Ra 223 dichloride) injection in combination with Zytiga (abiraterone acetate; Janssen) and prednisone/prednisolone for the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve patients with bone predominant metastatic castration-resistant prostate cancer (mCRPC). Xofigo is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases.
The randomized, double-blind, placebo-controlled trial is designed to determine the effects of this combination treatment on symptomatic skeletal event-free survival (SSE). Approximately 800 patients will be enrolled and randomized in a 1:1 ratio to receive study treatment (either radium-223 or placebo in addition to abiraterone acetate plus prednisone/prednisolone and best supportive care for the first six cycles followed by abiraterone acetate plus prednisone/prednisolone thereafter) until an on-study SSE occurs or other withdrawal criteria are met.
Xofigo is already approved for the treatment of patients with CRPC, symptomatic bone metastases and no known visceral metastatic disease. Zytiga is also approved in combination with prednisone or prednisolone in men with metastatic prostate cancer in whom the disease has progressed while receiving treatment with androgen deprivation therapy.
For more information call (800) 288-8371 or visit BayerHealthCare.com.