Dr. Renzulli on Expanded Access Program With Radium-223

Joseph F. Renzulli, II, MD, FACS, assistant professor of surgery (urology) clinical, Alpert Medical School, discusses the expanded-access program (EAP) in the United States for radium-223 dichloride in patients with metastatic castration-resistant prostate cancer (mCRPC).

A total of 184 patients in the United States were enrolled into the program, which was aimed to monitor acute and long-term safety of radium-223 with concurrent therapy of enzalutamide or abiraterone. This is in comparison to the ALSYMPCA trial, in which 65% of patients had previously received abiraterone and 46% were concurrently treated with abiraterone or enzalutamide. Median overall survival was 17 months in the EAP setting compared with 15 months in the ALSYMPCA trial. This is encouraging, Renzulli adds, in terms of combining therapies.

Concurrent treatment of enzalutamide or abiraterone with radium-223 did not demonstrate additional adverse events beyond what was seen in the ALSYMPCA trial. As next steps, Renzulli says he looks forward to ongoing clinical trials examining combined therapies in this setting.