Clinical Trial: Non-interventional Study With Ra-223 Dichloride Assessing Overall Survival and Effectiveness Predictors for mCRPC Patients in a Real Life Setting in Germany

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: 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 Pred

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 of chemotherapy naïve 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.

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: Overall survival (OS) [ Time Frame: Up to 30 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Bayer

Dates:
Date Received: May 19, 2015
Date Started: May 28, 2015
Date Completion: June 30, 2021
Last Updated: May 15, 2017
Last Verified: May 2017