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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)

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04516161
Acronym
EPIX
Enrollment
1180
Registered
2020-08-18
Start date
2020-08-03
Completion date
2021-03-31
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Castration Resistant Prostate Cancer (mCRPC)

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).

Interventions

DRUGRadium-223 dichloride (Xofigo, BAY88-8223)

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

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Overall survival from initiation of Ra-223Retrospective analysis from Jan 2013 to Dec 2019

Secondary

MeasureTime frameDescription
Percentage of Prostate Specific Antigen (PSA) (unit: µg/L) response after Ra-223Retrospective analysis from Jan 2013 to Dec 2019PSA response will be defined ≥ 50% reduction in baseline PSA level after initiation of Ra-223

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026