Trial Condition(s):
Metastatic castration resistant prostate cancer (mCRPC)
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) (EPIX)
Bayer Identifier:
20977
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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).
Inclusion Criteria
- Adult patients with documented diagnosis of mCRPC (≥18 years at diagnosis), and - Received Ra-223 as one of the therapies between Jan 1, 2013 and Jun 31, 2019 after diagnosis of mCRPC
Exclusion Criteria
- Patients involved in clinical trials
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Bayer Flatiron Xofigo Registry database Whippany, United States, 07981 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Patients with metastatic castrate-resistant prostate cancer (mCRPC) treated with Radium-223 (Xofigo): Patient characteristics and predictors of long-term survival
Trial Type:
Observational
Intervention Type:
N/A
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Overall survival from initiation of Ra-223Timeframe: Retrospective analysis from Jan 2013 to Dec 2019
Secondary Outcome
- Percentage of Prostate Specific Antigen (PSA) (unit: µg/L) response after Ra-223PSA response will be defined ≥ 50% reduction in baseline PSA level after initiation of Ra-223Timeframe: Retrospective analysis from Jan 2013 to Dec 2019
Additional Information
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