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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47140
• EU PAS number:
  EUPAS10391
• Study ID:
  47140
• Official title and acronym:
  FUJI study: Follow-Up of Jevtana® in real lIfe
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Prostate 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.
• Study status:
  Finalised

Research institution and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

Multiple centres: 45 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 06/01/2015

Study start date

Actual: 30/10/2015

Data analysis start date

Actual: 09/06/2017

Date of interim report, if expected

Actual: 28/08/2017

Date of final study report

Actual: 27/03/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi

Study protocol

Initial protocol

FUJI-ENCePP-PROTOCOL comp HAS approved vs amdt 18 mai 2015_avec logo

Updated protocol

FUJI-Protocole Amendement N°2

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable