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)

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04516161
• Collaborator: (none)
• Enrollment: 1,180
• Location: 1
• Actual Duration (Months): 7.9
• Patients Per Site Per Month: 149.7

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Metastatic Castration Resistant Prostate Cancer (mCRPC)	Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Study Design

• Study Type: Observational
• Actual Enrollment: 1180 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC) Treated With Radium-223 (Xofigo): Patient Characteristics and Predictors of Long-term Survival
• Actual Study Start Date: Aug 3, 2020
• Actual Primary Completion Date: Mar 31, 2021
• Actual Study Completion Date: Mar 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Overall survival from initiation of Ra-223 [Retrospective analysis from Jan 2013 to Dec 2019]

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bayer Flatiron Xofigo Registry database	Whippany	New Jersey	United States	07981

Sponsors and Collaborators

• Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here to find results for studies related to Bayer products

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT04516161
• Other Study ID Numbers: 20977
• First Posted: Aug 18, 2020
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms; Radium Ra 223 dichloride

Study Results

No Results Posted as of Mar 31, 2022