New Phase III trial of Xofigo in metastatic Prostate Cancer - Bayer HealthCare

Bayer HealthCare has begun to enroll patients in a trial studying Xofigo (radium Ra 223 dichloride) injection in combination with abiraterone acetate and prednisone/prednisolone for the treatment of asymptomatic or mildly symptomatic chemotherapy-naive patients with bone predominant metastatic castration-resistant Prostate Cancer (mCRPC). The randomized, double-blind, placebo-controlled Phase III trial is designed to determine the effects of this combination treatment on symptomatic skeletal event-free survival.

The trial will enroll approximately 800 patients who will be 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 symptomatic skeletal event (SSE) occurs (or other withdrawal criteria are met). It will be conducted in collaboration with Janssen Research and Development in various regions, including sites in Europe, the US, Australia, Brazil and Japan. Xofigo is approved by the FDA for the treatment of patients with CRPC, symptomatic bone metastases and no known visceral metastatic disease.