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)

Metastatic Castration Resistant Prostate Cancer (mCRPC) Clinical Trial

— EPIX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04516161
• Other study ID #: 20977
• Status: Completed
• Start date: August 3, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: March 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1180
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Castration Resistant Prostate Cancer (mCRPC)
• Prostatic Neoplasms

Intervention

Drug:
• Radium-223 dichloride (Xofigo, BAY88-8223)
Receiving Ra-223 either alone or in combination with other cancer therapies at any time after diagnosis of mCRPC

Locations

Country	Name	City	State
United States	Bayer Flatiron Xofigo Registry database	Whippany	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival from initiation of Ra-223		Retrospective analysis from Jan 2013 to Dec 2019
Secondary	Percentage of Prostate Specific Antigen (PSA) (unit: µg/L) response after Ra-223	PSA response will be defined = 50% reduction in baseline PSA level after initiation of Ra-223	Retrospective analysis from Jan 2013 to Dec 2019

External Links

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