check_circleStudy Completed

Metastatic castration resistant prostate cancer (mCRPC)

Bayer Identifier:

20977

ClinicalTrials.gov Identifier:

NCT04516161

EudraCT Number:

Not Available

EU CT Number:

Not Available
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)

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).

Key Participants Requirements

Sex

All

Age

18 - N/A
  • 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
1180
Trial Dates
August 2020 - March 2021
Phase
N/A
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Bayer Flatiron Xofigo Registry databaseWhippany, 07981, United States

Primary Outcome

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

Secondary Outcome

  • 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
    date_rangeTime Frame:
    Retrospective analysis from Jan 2013 to Dec 2019

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
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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