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)

Overview

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).

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: March 31, 2021

Interventions

  • 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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Overall survival from initiation of Ra-223
    • Time Frame: Retrospective analysis from Jan 2013 to Dec 2019

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor

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