An Observational Study to Compare cardiovascular related hospitalization in chemo-naïve Patients with Metastatic Castration Resistant Prostate Cancer, treated with Enzalutamide or Abiraterone in daily practice in Germany (AVENGER)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  To analyze and compare the risk of CV events in chemotherapy-naïve patients with mCRPC who initiated treatment with enzalutamide or abiraterone.

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective, non-interventional cohort study

Study drug and medical condition

• Medical condition to be studied:
  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:
  2418

Study design details

• Main study objective:
  The primary objective of this study is to analyze and compare the risk of CV events in chemotherapy-naïve patients with mCRPC who initiated treatment with enzalutamide or abiraterone.
• Outcomes:
  Time to first CV event, defined as CV-related hospitalization. • Number of CV events per patient, defined as CV-related hospitalizations • Baseline characteristics: age, Charlson comorbidity index, cardioembolic risk score, presence of specific comorbidities, number of urologist visits, number of hospitalizations • Treatment sequences and durations of treatments
• Data analysis plan:
  • Matching of the comparative groups via propensity score model. • Primary outcome: Kaplan-Meier analysis and Cox Proportional Hazard model to estimate hazard ratio, 95% confidence interval and p-value • Descriptive analysis for baseline characteristics secondary outcome. • Treatment sequences and durations secondary outcome: Descriptive analysis, Kaplan-Meier analysis.