Addition of radium-223 to abiraterone acetate and prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases (ERA 223): A randomised, double-blind, placebo-controlled, phase 3 trial
The Lancet Oncology Feb 13, 2019
Smith M, et al. - Researchers evaluated concurrent treatment with abiraterone acetate plus prednisone or prednisolone and radium-223 in patients with metastatic castration-resistant prostate cancer. They randomly (1:1) administered six intravenous injections of radium-223 (55 kBq/kg) or matching placebo once every 4 weeks to eligible patients (aged 18 years or older, and had histologically confirmed, progressive, chemotherapy-naive, asymptomatic or mildly symptomatic castration-resistant prostate cancer and bone metastases, Eastern Cooperative Oncology Group performance status of 0 or 1, life expectancy of at least 6 months, and adequate haematological, renal, and liver function). They also administered oral abiraterone acetate 1000 mg once daily plus oral prednisone or prednisolone 5 mg twice daily during and after radium-223 or placebo treatment to all patients. Findings revealed no improvement in symptomatic skeletal event-free survival with the addition of radium-223 to abiraterone acetate plus prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases. Also, this treatment strategy resulted in an increased frequency of bone fractures vs placebo. Therefore, the use of this combination was not recommended.
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