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Clinical Trials/NCT04516161
NCT04516161
Completed
Not Applicable

Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC) Treated With Radium-223 (Xofigo): Patient Characteristics and Predictors of Long-term Survival

Bayer1 site in 1 country1,180 target enrollmentAugust 3, 2020

Overview

Phase
Not Applicable
Intervention
Radium-223 dichloride (Xofigo, BAY88-8223)
Conditions
Metastatic Castration Resistant Prostate Cancer (mCRPC)
Sponsor
Bayer
Enrollment
1180
Locations
1
Primary Endpoint
Overall survival from initiation of Ra-223
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

In this observational study researchers want to gather more information about the characteristics of patients treated with Radium-223 (Xofigo) who had survived over a long period of time prostate cancer that had spread to other places in the body and keeps growing even when the amount of testosterone in the body is reduced to very low levels (metastatic castration-resistant prostate cancer, mCRPC). In addition researchers want to identify the factors which may contribute to survival over a long period of time in those patients. Radium-223 (Ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).

Registry
clinicaltrials.gov
Start Date
August 3, 2020
End Date
March 31, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bayer
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Radium-223 dichloride (Xofigo, BAY88-8223)

Patients with mCRPC who received treatment of Ra-223.

Intervention: Radium-223 dichloride (Xofigo, BAY88-8223)

Outcomes

Primary Outcomes

Overall survival from initiation of Ra-223

Time Frame: Retrospective analysis from Jan 2013 to Dec 2019

Secondary Outcomes

  • Percentage of Prostate Specific Antigen (PSA) (unit: µg/L) response after Ra-223(Retrospective analysis from Jan 2013 to Dec 2019)

Study Sites (1)

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