Status: Ongoing First registered on: 11/07/2018
Last updated on: 06/11/2018
1. Study identification
EU PAS Register NumberEUPAS24796
Official titleURANIS –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
Study title acronymURANIS
Study typeObservational study
Brief description of the studyThis observational prospective single arm cohort study is designed to examine 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 self-care (Moses-Questionnaire), independence in activities of daily living and safety will be examined.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameBayer AG
Centre locationBerlin, Germany
Details of (Primary) lead investigator
Title Dr
Last name BAYER AG
First name Bayer Clinical Trials
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?66

AEMPS
Countries in which this study is being conducted
National study

Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed13/03/2015
Start date of data collection31/05/201528/05/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report30/09/2024
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBayer Pharma AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name BAYER AG
First name Bayer Clinical Trials
Address line 1Muellerstrasse 178
Address line 2 
Address line 3 
CityBerlin 
Postcode13342 
CountryGermany
Phone number (incl. country code)49-30300139005 
Alternative phone number 
Fax number (incl. country code) 
Email address clinical-trials-contact@bayer.com
Public Enquiries
Title Dr 
Last name BAYER AG 
First name Bayer Clinical Trials 
Address line 1Muellerstrasse 178 
Address line 2 
Address line 3 
CityBerlin 
Postcode13342 
CountryGermany 
Phone number (incl. country code)49-30300139005 
Alternative phone number 
Fax number (incl. country code) 
Email address clinical-trials-contact@bayer.com 
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