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Completed

NCT Number: NCT04516161

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)

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).

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Key information

Conditions

Metastatic Castration Resistant Prostate Cancer (mCRPC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bayer Flatiron Xofigo Registry database

Whippany, New Jersey, 07981, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radium-223 dichloride (Xofigo, BAY88-8223)

Drug

Receiving Ra-223 either alone or in combination with other cancer therapies at any time after diagnosis of mCRPC

Primary outcomes

  1. Overall survival from initiation of Ra-223

    Time frame: Retrospective analysis from Jan 2013 to Dec 2019

Secondary outcomes

  1. Percentage of Prostate Specific Antigen (PSA) (unit: µg/L) response after Ra-223

    Time frame: Retrospective analysis from Jan 2013 to Dec 2019

    PSA response will be defined ≥ 50% reduction in baseline PSA level after initiation of Ra-223

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: EPIX

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 18, 2020
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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