Trial design
oligometastatic CRPC, Cancer
INFECTIOUS DISEASES, METASTASES, BONE METASTASES, CANCER
This study is designed as a randomized, open-label, phase II, multicenter (Tokyo Medical and Dental University, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Cancer Institute Hospital of JFCR, Saitama Cancer Center, Osaka International Cancer Institute, and Kanazawa University) trial in Japan. Patients will be randomized 1:1 into two groups in order to evaluate the efficacy of radium-223 in addition to targeted radiation therapy for active bone metastatic lesions in combination with best standard of care (BSoC) in patients with oligometastatic CRPC whose metastases are confined to bone, with radiological progression-free survival to exacerbation of bone metastases on WB-DWI as the primary endpoint. The study protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT: see Additional file 