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

Bayer

Status: Completed

Conditions: Metastatic Castration-resistant Prostate Cancer

Treatments: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Study type: Observational

Funder types: Industry

Identifiers

NCT02141438

16913

Details and patient eligibility

About

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.

Enrollment: 1,472 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,472 participants in 1 patient group

Radium-223 dichloride (Xofigo, BAY88-8223)

Description:

Single-arm cohort observational study with CRPC patients with bone metastasis treated with Radium-223.

Treatment:

Drug: Radium-223 dichloride (Xofigo, BAY88-8223)