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Abstract

Volume 28, Issue 5 (September 2026) 28, 561–567; 10.4103/aja202598

Real-world effectiveness and safety of radium-223 therapy in castration-resistant prostate cancer with bone metastases

Wang, Hong-Kai1,2,3,*; Hang, Zhen1,2,3,*; Liu, Chang2,4; Dai, Bo1,2,3; Zhu, Yao1,2,3; Qin, Xiao-Jian1,2,3; Lin, Guo-Wen1,2,3; Deng, Yan-Bo5; Jiang, He-Xun5; Wang, Ya5; Song, Shao-Li2,4; Ye, Ding-Wei1,2,3

1Department of Urology, Fudan University Shanghai Cancer Center, Shanghai 201321, China

2Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200433, China

3Shanghai Genitourinary Cancer Institute, Shanghai 200032, China

4Department of Nuclear Medicine, Fudan University Shanghai Cancer Center, Shanghai 201321, China

5Pharmaceuticals, Bayer Healthcare Company Ltd., Beijing 100176, China

Correspondence: Dr. DW Ye (dwyeli@163.com) or Dr. C Liu (lcggtt@163.com)

Received: 15 May 2025; Accepted: 16 December 2025; published online: 03 March 2026

Abstract

The effectiveness and safety of radium-223 (Ra-223) in patients with metastatic castration-resistant prostate cancer (mCRPC) and bone metastasis in real-world clinical practice in China remain to be fully examined. This single-center, retrospective, real-world study included Chinese patients with mCRPC treated with Ra-223 between January 2021 and August 2023 in Fudan University Shanghai Cancer Center (Shanghai, China). This study examined the patient characteristics, overall survival (OS), 5-point Visual Analog Scale for pain and safety, as well as factors potentially influencing treatment effectiveness. Ninety-three patients were included. Among them, 25 (26.9%) patients were administered all six injections of Ra-223, and 41 (44.1%) patients received more than 3 injections. After a median follow-up of 19.8 months, median OS was 14.1 (95% confidence interval [CI]: 12.0–16.2) months. Multivariable analysis showed a total number of Ra-223 injections >3 was an independent protective factor of OS (hazard ratio [HR] = 0.443, 95% CI: 0.234–0.837; P = 0.012) after adjusting for age, combination therapy, and previous chemotherapy. For those administered all six injections of Ra-223, no patients had a pain score of 4 and only 4.2% of patients showed a pain score of 3. In total, 62.5% of patients had almost no pain (0 point). Median alkaline phosphatase showed a downward trend during the six-injection treatment period. The most common adverse event was anemia (30.1%), followed by thrombocytopenia (15.1%), nausea (9.7%), weakness (8.6%), and decreased white blood cells (7.5%). This real-world study strongly suggests that Ra-223 has good effectiveness and tolerability in Chinese patients with mCRPC and bone metastases.

Keywords: bone metastasis; castration-resistant prostate cancer; radium 223; real-world study; treatment effect

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Asian Journal of Andrology CN 31-1795/R ISSN 1008-682X  Copyright © 2023  Shanghai Materia Medica, Chinese Academy of Sciences.  All rights reserved.