Trial Condition(s):

Castration-Resistant Prostate Cancer

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 (RAPIT)

Bayer Identifier:

21124

ClinicalTrials.gov Identifier:

NCT04232761

EudraCT Number:

Not Available

Recruiting

Trial Purpose

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).

Inclusion Criteria
- Histologically or cytologically confirmed castration-resistant adenocarcinoma of the prostate with bone metastases
  - Treatment decision for Radium-223 according to local label needs to be made independent from and before patient enrollment in the study by the investigator
  - No contra-indications according to the local marketing authorization
Exclusion Criteria
- Previously treated with Radium-223 for any reason
  - Currently treated in clinical trials including other Radium-223 studies or planned participation in an investigational program with interventions outside of routine clinical practice during the study period

Trial Summary

Enrollment Goal
300
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many locations

Many locations, Taiwan, China

Status
Recruiting
 

Trial Design