EPIX, a Study to Gather More Information About Characteristics of Patients and Other Factors Which May Contribute to Survival Over a Long Period of Time in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Treated With Radium-223 (Xofigo)

Completed

• Conditions: Metastatic Castration Resistant Prostate Cancer (mCRPC)
• Interventions: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

• Registration Number: NCT04516161
• Lead Sponsor: Bayer

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-27
• Study Start: 2020-08-03
• Study First Submitted QC: 2020-08-13
• Study First Posted: 2020-08-18
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radium-223 dichloride (Xofigo, BAY88-8223)	Radium-223 dichloride (Xofigo, BAY88-8223)	Patients with mCRPC who received treatment of Ra-223.

Primary Outcome Measures

Name	Time	Method
Overall survival from initiation of Ra-223	Retrospective analysis from Jan 2013 to Dec 2019

Secondary Outcome Measures

Name	Time	Method
Percentage of Prostate Specific Antigen (PSA) (unit: µg/L) response after Ra-223	Retrospective analysis from Jan 2013 to Dec 2019	PSA response will be defined ≥ 50% reduction in baseline PSA level after initiation of Ra-223

Trial Locations

Locations (1)

Bayer Flatiron Xofigo Registry database; 🇺🇸 Whippany, New Jersey, United States