Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)
Safety study (incl. comparative)

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

Anatomical Therapeutic Chemical (ATC) code

(L01CD04) cabazitaxel
cabazitaxel
Population studied

Short description of the study population

Prostate cancer patients initiating cabazitaxel.

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

Prostate cancer

Estimated number of subjects

460
Study design details

Main study objective

To evaluate the overall survival of patients treated by cabazitaxel and according to treatment-line

Outcomes

Overall survival is defined as the interval between the date of first administration of cabazitaxel (inclusion date) and the date of death, irrespective of cause, Safety based on data collected through medical file (NCI-CTCAE v4.0 toxicity scale and MEDdRA code), QoL and pain based on FACT-P and BPI-SF questionnaire. Description of analgesic use, patient's characteristics and cabazitaxel use. PFS defined as interval between inclusion date and date of progressive disease (radiological evaluation, RECIST criteria, clinical and biological parameters).

Data analysis plan

A detailed statistical analysis plan (SAP) will be performed before database lock using SAS® software (latest current version).
The SAP will be validated by Scientific Committee. Descriptive statistics including mean, median, standard deviation, minimum, and maximum will be presented for continuous variables. For categorial variables, the number of subjects and percentage within each category will be presented. Describing analyses will concern prescriber recruitment, baseline demographic and clinical characteristics at inclusion date, treatment pattern during follow-up after inclusion date, toxicities by patient, and quality of life, pain and analgesic consumption. Overall and progression-free survival outcomes will be analysed using Kaplan Meier method and median survival will be reported with 95%CI (adjusted on previous treatment). Multivariate analysis will be using the Cox proportional hazard risk model to assess the factors associated with mortality and progression of disease.