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

• Status: Active, not recruiting
• Trial end date: 2025-02-28
• Target enrollment: 0
• Participant gender: Male

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Radium Ra 223 dichloride

Criteria

Inclusion Criteria:

• Treatment decision to Radium-223 needs to be made independent from and before patient enrollment in the study

• Histologically or cytologically confirmed castration resistant adenocarcinoma of the prostate with bone metastases

• Signed informed consent

Exclusion Criteria:

• Previously treated with Radium-223 for any reason

• Currently treated in clinical trials including other Radium-223 studies

• Planned for the systemic concomitant use of other radiopharmaceuticals for treatment of prostate cancer or for other use