Clinical Trials Directory

Trials / Completed

CompletedNCT02141438

Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer

Radium-223 Alpha Emitter Agent in Non-intervention Safety Study in mCRPC popUlation for Long-teRm Evaluation

Status
Completed
Phase
Study type
Observational
Enrollment
1,472 (actual)
Sponsor
Bayer · Industry
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

Summary

Observational study in the routine clinical practice setting to evaluate the short and long term safety profile of Radium-223 in metastatic castration resistant prostate cancer patients and to evaluate the risk of developing second primary cancers.

Conditions

Interventions

TypeNameDescription
DRUGRadium-223 dichloride (Xofigo, BAY88-8223)This is a non-interventional study, the drug is used in its authorized indication from commercial supply. The decision to treat with Radium-223 will be agreed upon between the physician and the patient independently and prior to providing the patient study information. Treatment with Radium-223 should follow the approved local product information.

Timeline

Start date
2014-08-20
Primary completion
2024-08-02
Completion
2024-10-24
First posted
2014-05-19
Last updated
2025-10-16
Results posted
2025-09-05

Locations

68 sites across 20 countries: United States, Argentina, Austria, Belgium, Canada, Colombia, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Luxembourg, Mexico, Netherlands, Portugal, Spain, Sweden, United Kingdom

Source: ClinicalTrials.gov record NCT02141438. Inclusion in this directory is not an endorsement.