NCT04232761

Study to Gather Information on the Safety and How Radium-223 Dichloride, an Alpha Particle-emitting Radioactive Agent, Works Under Routine Clinical Practice in Taiwan in Patients With Castration-resistant Prostate Cancer (CRPC) Which Has Spread to the Bone

Safety and Effectiveness of Xofigo® (Radium-223 Dichloride) in Routine Clinical Practice Settings in Taiwan

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 194 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

In this observational study researchers want to gather more information about safety and survival in patients suffering from castration-resistant prostate cancer (CRPC) which has spread to the bone and were treated with radium-223 in routine clinical practice in Taiwan. Radium-223 (Ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).

Detailed description

The primary objective of the study is to describe the safety profile of radium-223 dichloride in patients having castration-resistent prostate cancer with symptomatic bone metastases and who are treated in routine clinical practice in Taiwan. The secondary objective is to assess the effectiveness of radium-223 dichloride in these patients.

Conditions

• Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Radium-223 dichloride (Xofigo, BAY88-8223)	Drug administration as determined by treating physician

Timeline

• Start date: 2020-07-07
• Primary completion: 2024-04-29
• Completion: 2024-04-29
• First posted: 2020-01-18
• Last updated: 2024-07-17

Locations

1 site across 1 country: Taiwan