Zhou T.Zhou F.Guo J.Shi H.Yao X.Guo H.Yuan J.Tian Y.Zhang X.Wang S.Jiang Y.Zou Q.Zhou D.Li H.Li F.Lee J.L.CHUNG-HSIN CHENPark S.H.Ng Q.S.Ma J.Zheng R.Ding Q.Liu X.Li R.Krissel H.Wagner V.J.Sun Y.2021-01-262021-01-2620201743-7555https://www.scopus.com/inward/record.uri?eid=2-s2.0-85092455674&doi=10.1111%2fajco.13479&partnerID=40&md5=73ed9b6f5b90b6dff331a797c7278764https://scholars.lib.ntu.edu.tw/handle/123456789/542062Aim: Radium-223, a targeted alpha therapy, is approved widely for the treatment of patients with metastatic castrate-resistant prostate cancer, based on a pivotal phase 3 study in predominantly white patients. We investigated the efficacy and safety of radium-223 in Asian patients with castrate-resistant prostate cancer and metastatic bone disease. Methods: This multicenter, prospective, single-arm, open-label phase 3 trial evaluated the efficacy and safety of the standard radium-223 regimen (55 kBq/kg every 4 weeks for six cycles) in patients from Asian countries. The primary endpoints were the safety and overall survival. Results: A total of 226 patients were enrolled and received at least one dose of radium-223. Median overall survival was 14.0 months (95% confidence interval [CI], 11.2–17.4). Median time to total alkaline phosphatase and prostate-specific antigen progression were 7.5 (95% CI, 6.8–7.7) and 3.6 (95% CI, 3.1–3.7) months, respectively. Median skeletal-related event-free survival was 26.0 months (95% CI, 12.6–not reached). Grade ?3 treatment-emergent adverse events were reported in 103 (46%) of 226 patients, with anemia being the most common event (34 [15%] patients). Grade ?3 drug-related treatment-emergent adverse events occurred in 39 (17%) of 226 patients. Serious treatment-emergent adverse events were reported in 65 (29%) of 226 patients. Seven (3%) patients had an adverse event leading to death; none were considered to be related to radium-223. Conclusion: The results of this study support the use of the standard radium-223 regimen for the treatment of Asian patients with castrate-resistant prostate cancer and symptomatic bone metastases. ? 2020 The Authors. Asia-Pacific Journal of Clinical Oncology published by John Wiley & Sons Australia, LtdAsian patients; bone metastases; castrate-resistant prostate cancer; radium-223; targeted alpha therapy[SDGs]SDG3radioisotope; radium; Radium-223; bone tumor; castration resistant prostate cancer; clinical trial; human; male; multicenter study; phase 3 clinical trial; prospective study; Bone Neoplasms; Humans; Male; Prospective Studies; Prostatic Neoplasms, Castration-Resistant; Radioisotopes; Radiumjournal article10.1111/ajco.134792-s2.0-85092455674