Trial Condition(s):

Prostatic Neoplasms, Castration-Resistant

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 Identifier:

18043

ClinicalTrials.gov Identifier:

NCT02450812

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
86
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many Locations

Many Locations, Germany

Status
Completed
 

Trial Design