Radium-223 alpha Emitter Agent in non-intervention Safety Study in mCRPC popUlation for long-teRm Evaluation (REASSURE)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Non-randomised observational trial

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (V10XX03) radium (223Ra) dichloride

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

Population studied

• 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)
• Estimated number of subjects:
  1334

Study design details

• Main study objective:
  To assess the incidence of all second primary malignancies in mCRPC patients treated with Radium-223, incidence of treatment-emergent SAEs, drug-related treatment emergent AEs, drug-related SAEs up to 7 years after last administration, and bone marrow suppression.
• Outcomes:
  -Incidence of developing second primary malignancies-Incidence of treatment-emergent SAEs -Incidence of drug-related treatment-emergent adverse events-Incidence of drug-related SAEs-Bone marrow suppression, -Overall survival-The worst pain score and pain interference score over time as determined by patient responses on the "Brief pain inventory short form" (BPI-SF) questionnaire-Incidence of bone fractures-The number of bone associated events
• Data analysis plan:
  Demographic data, baseline cancer characteristics, concomitant diseases, concomitant medication, BPI-SF of the included patients will be described with summary statistics. Development of second primary malignancy will be summarized using the incidence proportion and in-addition, the exposure-adjusted incidence rate (EAIR). The corresponding exact 95% confidence intervals will be given.Descriptive summaries of Kaplan-Meier (KM) estimates and KM curves will be presented for overall survival. Adverse events will be summarized using MedDRA and the NCI-CTCAE coding system. The incidence proportion and EAIR will be estimated along with the corresponding exact 95% confidence interval.For the comparison with external reference group, incidence of second primanry malignacies in mCRPC patients treated with radium-223 from the REASSURE-study will be compared with corresponding information on patients with mCRPC indetified in the external secondary data source(s).