Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-24 @ 11:59 AM
Study NCT ID:
NCT04232761
Status:
COMPLETED
Last Update Posted:
2024-07-17
First Post:
2020-01-15
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
Safety and Effectiveness of Xofigo® (Radium-223 Dichloride) in Routine Clinical Practice Settings in Taiwan
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAPIT
Brief 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.
The secondary objective is to assess the effectiveness of radium-223 dichloride in these patients.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: