Status: PlannedLast updated on: 15/09/2015
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 hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. 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 including 440 patients initiating cabazitaxel between September 2013 and February 2016, of which 400 patients expected for prostate cancer followed during 18 months. The primary objective of the study is to evaluate the overall survival for the whole cohort and according to the treatment-lines. The secondary objectives were to evaluate the safety and progression-free survival for the whole cohort, and quality of life and pain for a subgroup of 60-80 patients. A description was also performed concerning the characteristics of the treated study population and the conditions of cabazitaxel use in a real-life setting. 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 influencing prescription and to offer exhaustive coverage for each centre, irrespective of indication. Data collection will be performed by coordinating centre CRAs from the patient’s medical records using an e-CRF. A sub-group of patients will be included prospectively and directly by physicians for the study of quality of life and pain, with questionnaires completed by patient before each perfusion during the treatment period.
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)?
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 collection15/10/2015
Start date of data analysis31/05/2017
Date of interim report, if expected
Date of final study report30/09/2017
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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