| Company Name | Bayer Taiwan Co., Ltd. |
|---|---|
| Protocol Number | 21124 |
| Title of Study | RAPIT/ Safety and Effectiveness of Xofigo® (Radium-223 dichloride) in Routine Clinical Practice Settings in Taiwan) |
| Primary Objective | To describe the safety profiles and the effectiveness of Radium-223 in CRPC patients with symptomatic bone metastases under routine clinical practice in Taiwan. The objective of the extended follow-up period (up to 2 years after the first injection of Radium-223) is to describe the long term safety information (i.e. hematological AEs, events of bone fracture or osteoporosis), and survival in CRPC patients post-treatment of Radium-223 under real-world practice in Taiwan. |
| Number of Sites | 10 |
| Period of Study | From：2020 Q3 to：2023 Q4 |
| Number of Patients | 300人 |
| IRB Approval Date | NTUH 2020/03/17 TPVGH 2020/05/01 CGMHLK 2020/04/29 KFSYSCC In Process TSGH 2020/04/18 CMUH 2020/05/07 TCVGH 2020/05/25 CYCH 2020/05/20 KMUH 2020/05/07 CHIMEI In Process |
| Publication Plan / Date | 2024 Q1 |
