A Registry in the European Union of Provenge Therapy in Men with Metastatic Castrate-Resistant Prostate Cancer (START)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  non-interventional PASS

Study drug and medical condition

• Name of medicine:
  PROVENGE
• Medical condition to be studied:
  Prostate cancer metastatic

  Hormone-refractory prostate cancer

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:
  850

Study design details

• Main study objective:
  To evaluate the risk of ischemic stroke or MI following treatment with Provenge relative to the risk reported in external databases of patients with mCRPC not treated with Provenge.
• Outcomes:
  The primary endpoint is incidence of ischemic stroke or MI occurring from the first infusion through 60 days after the final infusion of Provenge. To assess the primary endpoint, data from this registry will be combined with data from PROCEED, the US registry enrolling >1500 men with advanced prostate cancer. •Collect data on the occurrence of DVT or PE following treatment with Provenge•Collect data on the occurrence of SAEs following treatment with Provenge•Collect data on OS in subjects who receive Provenge•Describe time to first prostate cancer intervention in subjects who receive Provenge •Describe changes in PSA levels, use of other prostate cancer interventions after treatment with Provenge
• Data analysis plan:
  The primary endpoint is the incidence of ischemic stroke or MI occurring form the time of first infusion through 60 days after the final infusion and will be assessed combining data from this registry and PROCEED. It will be summarized in aggregate and where possible by subgroup. The incidence, incidence rate per patient-year, and 95% confidence intervals will be calculated. Comparisons to external databases will be performed by calculating incidence risk ratios and their corresponding 95% confidence intervals. Secondary endpoints to be evaluated include the incidence of ischemic stroke, MI, DVT, and PE as well as overall survival, incidence of SAEs, prostate cancer interventions, and serum PSA levels. An exploratory meta-analysis combining data from this registry,PROCEED and completed/ongoing Provenge studies in subjects with advanced prostate cancer to evaluate the risk of MI in patients with mCRPC treated with Provenge relative to not treated with Provenge will be performed.