Non-interventional Study With Ra-223 Dichloride Assessing Overall Survival and Effectiveness Predictors for mCRPC Patients in a Real Life Setting in Germany (URANIS)

Bayer

Status: Completed

Conditions: Prostatic Neoplasms, Castration-Resistant

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02450812

18043

EUPAS24796 (Other Identifier)

XF 1503 (Other Identifier)

Details and patient eligibility

About

This observational prospective single arm cohort study is designed to assess overall survival, symptomatic skeletal event free survival and quality of life of metastatic Castration Resistant Prostate Cancer (mCRPC) patients receiving Radium- 223 under real life conditions. In addition, time to next tumor treatment (TTNT), mobility, quality of life and selfcare, independence in activities of daily living and safety will be assessed.

Enrollment: 86 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male patients diagnosed with castration resistant adenocarcinoma of the prostate (CRPC) with symptomatic bone metastases without known visceral metastases
• Decision to initiate treatment with Radium-223 was made as per investigator's routine treatment practice

Exclusion criteria

-Patients participating in an investigational program with interventions outside of routine clinical practice and also in all non-interventional studies focusing on Radium- 223-dichloride.

Trial design

86 participants in 1 patient group

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

Description:

patients with mCRPC with symptomatic bone metastases

Treatment:

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