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)

NCT ID: NCT04516161

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-03

Study Completion Date

2021-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Metastatic Castration Resistant Prostate Cancer (mCRPC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Radium-223 dichloride (Xofigo, BAY88-8223)

Patients with mCRPC who received treatment of Ra-223.

Radium-223 dichloride (Xofigo, BAY88-8223)

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bayer Flatiron Xofigo Registry database

Whippany, New Jersey, United States

Site Status

Countries

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United States

References

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George DJ, Agarwal N, Sartor O, Sternberg CN, Tombal B, Saad F, Miller K, Constantinovici N, Guo H, Reeves J, Jiao X, Sandstrom P, Verholen F, Higano CS, Shore N. Real-world patient characteristics associated with survival of 2 years or more after radium-223 treatment for metastatic castration-resistant prostate cancer (EPIX study). Prostate Cancer Prostatic Dis. 2022 Feb;25(2):306-313. doi: 10.1038/s41391-021-00488-0. Epub 2022 Feb 21.

Reference Type DERIVED
PMID: 35190653 (View on PubMed)

Related Links

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https://clinicaltrials.bayer.com/

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Other Identifiers

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20977

Identifier Type: -

Identifier Source: org_study_id

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