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Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer

NCT02141438 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1472

Last updated 2025-10-16

Study results available
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Summary

Observational study in the routine clinical practice setting to evaluate the short and long term safety profile of Radium-223 in metastatic castration resistant prostate cancer patients and to evaluate the risk of developing second primary cancers.

Conditions

Interventions

DRUG

Radium-223 dichloride (Xofigo, BAY88-8223)

This is a non-interventional study, the drug is used in its authorized indication from commercial supply. The decision to treat with Radium-223 will be agreed upon between the physician and the patient independently and prior to providing the patient study information. Treatment with Radium-223 should follow the approved local product information.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-20
Primary Completion
2024-08-02
Completion
2024-10-24

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Canada
  • Colombia
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Luxembourg
  • Mexico
  • Netherlands
  • Portugal
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02141438 on ClinicalTrials.gov