Clinical experience with cabazitaxel in patients with metastatic castrate resistant prostate cancer (ECLIPSE) (ELIPSE)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product

  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational retrospective study

Study drug and medical condition

• Additional medical condition(s):
  Metastatic castrate resistant prostate cancer

Population studied

• Short description of the study population:
  Male patients diagnosed with metastatic castrate resistant prostate cancer (mCRPC) and had received cabazitaxel following failure of previous docetaxel treatment.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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:
  Metastatic castrate resistant prostate cancer patients
• Estimated number of subjects:
  150

Study design details

• Main study objective:
  Primary objective: To describe the anti-cancer treatment pathways for patients who have received cabazitaxel following prior docetaxel treatmentSecondary objectives:To describe the clinical outcomes of patientsTo describe the characteristics of patientsTo describe side effects associated with cabazitaxel use
• Data analysis plan:
  Analyses are descriptive in nature.Nominal variables are described with frequencies and percentages, while ordinal variables are presented as medians and interquartile ranges (IQR). Time-to-event variables (progression-free survival PFS and overall survival OS) were analysed by the Kaplan-Meier method with data presented as survival plots and summarised as median, standard error (SE) and 95% confidence intervals 95% CI, within the follow up period available for each patient (i.e. patients still living at the date of data collection werecensored at the date of data collection for analysis of OS and patients still alive and not recorded as progressing at the time of data collection were censored on that date for analysis of PFS).