FUJI study: Follow-Up of Jevtana® in real lIfe

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 and secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L01CD04) cabazitaxel

Population studied

• Short description of the study population:
  Prostate cancer patients initiating cabazitaxel.
• 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)
• 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.

Documents

Study results

FUJI-Summary of study results-ENCePP Final Report-20180605 VF

Study, other information

Synopsis FUJI vUK 28-07-2015 clean final version

Synopsis FUJI vUK amendement N°2 version clean 20180110

Study publications

Joly F, Oudard S, Fizazi K, Tubach F, Jove J, Lacueille C, Lamarque S, Guiard E…

Rouyer M, Oudard S, Joly F, Fizazi K, Tubach F, Jove J, Lacueille C, Lamarque S…