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 type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Overall survival
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  XOFIGO
• Study drug International non-proprietary name (INN) or common name:
  RADIUM RA 223 DICHLORIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (V10XX03) radium (223Ra) dichloride

  radium (223Ra) dichloride
• Medical condition to be studied:
  Prostate cancer metastatic

Population studied

• Short description of the study population:
  Male patients with a diagnosis of mCRPC with symptomatic bone metastases without known visceral metastases will be enrolled after the decision for treatment with Radium-223-dichloride has been made by the attending physician according to his/her medical practice. ; Inclusion criterion/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.;  Signed informed consent; Exclusion criterion/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.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Prostate cancer metastatic patients
• Estimated number of subjects:
  77

Study design details

• Main study objective:
  The primary objective of this study is to evaluate the overall survival during Radium-223 dichloride treatment of mCRPC patients in a real life setting.
• Outcomes:
  Overall survival, Explore symptomatic skeletal event free survival.Examine the incidence of treatment-emergent adverse events.Calculate the incidence of pathological fractures,non-pathological fractures and bone associated events.Explore treatments and time to subsequent mCRPC treatment.Examine the QoL as patient reported outcome using FACT-P.Explore independence in activities of daily livingby using the Katz-index
• Data analysis plan:
  Statistical analyses will be primarily of explorative and descriptive nature. All analyses will be provided for the complete study population, as well as separately for the chemotherapy naïve vs non naïve study population. Patients receiving at least one dose of Radium-223 will be considered valid for safety analysis set. Time to event variables (OS, SSE-FS, TTNT) will be summarized using Kaplan-Meier estimates. Median event times together with the 25th and 75th percentiles and associated 95% confidence intervals will be presented. Analyses of QoL will be performed for patients with evaluable patient questionnaires (FACT-P) at each visit. Descriptive statistics (e.g. means, mean changes) will be provided for each assessment time point. The study analyses will be descriptive and no formal hypothesis testing will be performed.