Status: FinalisedLast updated on: 05/06/2018
1. Study identification
EU PAS Register NumberEUPAS10391
Official titleFollow-Up of Jevtana® in real lIfe
Study title acronymFUJI
Study typeObservational study
Brief description of the studyProstate cancer is the most common cancer in France; it evolves slowly but there is a poor prognosis at the metastatic stage. Several therapeutic strategies are available such as hormonal therapies and chemotherapies. Cabazitaxel is a new taxane that has an European marketing authorization since March 2011 and indicated in the treatment of patients with metastatic castration-resistant prostate cancer previously treated with docetaxel. The availability of this treatment is recent (Dec 2012) and there is only limited data on the use, safety, and effectiveness of cabazitaxel in real-life practice. In this context, French health authorities request a French multicentre observational study. A retrospective cohort will be implemented with 400 patients initiating cabazitaxel from Sept 2013 to Aug 2015, followed 18 months and a prospective cohort with 60 patients initiating cabazitaxel from Mar 2016 to 28 Feb 2017, followed 6 months. The primary objective of the study is to evaluate the overall survival in the whole cohort and by treatment lines. The secondary objectives are to evaluate the safety, quality of life (QoL) and pain in the prospective cohort, to describe analgesic use, the characteristics of the treated study cohort and the conditions of cabazitaxel use in a real-life setting and to evaluate progression-free survival (PFS). The study will be conducted with participation of hospital pharmacists and physicians. A retrospective identification of patients will be performed by pharmacists from hospital pharmacy registers in order to avoid prescriber’s selection. Data collection will be performed by coordinating centre CRAs from the patient's medical records using an e-CRF. The QoL in the prospective cohort will be assessed using the FACT-P QoL questionnaire and pain will be evaluated by the Brief Pain Questionnaire - Short form (BPI-SF); these questionnaires will be completed by patients before each cabazitaxel infusion, up to the last cabazitaxel infusion.
Was this study requested by a regulator?Yes: France, Comité Economique des Produits de Santé (CEPS)
Is the study required by a Risk Management Plan (RMP)? Not applicable
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBordeaux pharmacoepi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.pharmacoepi.eu
Details of (Primary) lead investigator
Title Professor
Last name Moore
First name Nicholas
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?45
Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed06/01/2015
Start date of data collection30/10/2015
Start date of data analysis09/06/2017
Date of interim report, if expected28/08/2017
Date of final study report27/03/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesSanofi100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mrs
Last name Fourrier-Réglat
First name Annie
Address line 1146 Rue Leo Saignat
Address line 2Service de Pharmacologie 
Address line 3Université de Bordeaux - case 36 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557574657 
Alternative phone number33557571560 
Fax number (incl. country code) 
Public Enquiries
Title Mrs 
Last name Fourrier-Réglat 
First name Annie 
Address line 1146 Rue Leo Saignat 
Address line 2 
Address line 3 
CityBordeaux 
Postcode 
CountryFrance 
Phone number (incl. country code)33557574657 
Alternative phone number 
Fax number (incl. country code) 
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