URANIS -Data Collection in Urological Centers During Treatment With Ra-223 Dichloride (Xofigo) Within the Framework of a Non-interventional Study Assessing Overall Survival (OS) and Effectiveness Predictors of Ra-223 Dichloride Treated mCRPC Patients in a Real Life Setting in Germany.

Bayer1 site in 1 country86 target enrollmentMay 28, 2015

ConditionsProstatic Neoplasms, Castration-Resistant

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

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

Overview

Phase: Not Applicable
Intervention: Radium-223-dichloride (Xofigo, BAY88-8223)
Conditions: Prostatic Neoplasms, Castration-Resistant
Sponsor: Bayer
Enrollment: 86
Locations: 1
Primary Endpoint: Overall survival (OS)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 28, 2015

End Date

September 17, 2020

Last Updated

4 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

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

patients with mCRPC with symptomatic bone metastases

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

Outcomes

Primary Outcomes

Overall survival (OS)

Time Frame: Up to 60 months

Secondary Outcomes

Estimation of the non-pathological fractures(Up to 60 months)
Estimation of the bone associated events(Up to 60 months)
Estimation of the incidence of pathological fractures.(Up to 60 months)
Time to next tumor treatment(s) (TTNT)(Up to 24 months)
Quality of life as patient reported outcome estimated using Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire(Up to 60 months)
Body function assessed in dimensions of "mobility", "self-care" and "domestic life" using the Medical Oncology Status in Europe Survey (MOSES) questionnaire(Up to 7 months)
Evaluation of symptomatic skeletal event free survival (SSE-FS) of mCRPC patients(Up to 60 months)
Incidence of treatment-emergent adverse events (TEAE)(Up to 30 days after last administration of Radium-223)
Activities of daily living assessed according to the Katz-Index(Up to 7 months)