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

Study identification

• EU PAS number:
  EUPAS24796
• Study ID:
  43099
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Bayer AG

Study timelines

Date when funding contract was signed

Actual: 13/03/2015

Study start date

Planned: 31/05/2015

Actual: 28/05/2015

Date of final study report

Actual: 01/09/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer Pharma AG

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable