Status: Finalised First registered on: 10/04/2018
Last updated on: 12/09/2022
1. Study identification
EU PAS Register NumberEUPAS21285
Official titleTherapeutic strategy in metastatic castration-resistant prostate cancer: target population and changes between 2012 and 2014. Two sequential cohorts within the French nation-wide claims and hospital database
Study title acronymCAMERRA
Study typeObservational study
Brief description of the studyProstate cancer is the most common cancer in men and represents more than 57,000 new cases each year in France. Several therapeutic options are available at metastatic stage. Since 2004, docetaxel has been the first-line treatment of metastatic castration-resistant prostate cancer (mCRPC). Since 2011, several drugs (cabazitaxel, abiraterone, enzalutamide) successively received European market authorisation as second-line treatment and then as a first-line treatment for the last two. Changes in therapeutic strategies have a major impact on care for mCRPC patients. The research question is to assess the therapeutic strategy changes for mCRPC between 2012 and 2014, as well as the size of the population and healthcare use over three years. Two cohorts of mCRPC patients with a first treatment for mCRPC will be identified from the French nationwide claims and hospital database, and all patients will have a 5-year database history and will be followed during three years. The index date will be the date of the mCRPC first-line treatment initiation during the inclusion period (Cohort 2012: from 1 January 2012 to 31 December 2012, and − Cohort 2014: from 1 January 2014 to 31 December 2014). The main objective is to describe first-line treatment for patients with mCRPC in 2012 and 2014 and then subsequent-line treatments during a 3-year follow-up. Secondary objectives are to estimate the number of patients treated for a mCRPC in 2012 and 2014; to describe characteristics of patients treated for a mCRPC: demographic, comorbidities, and prostate cancer history; to estimate overall survival for all patients and according to the first-line treatment; to describe the complications that could be related to mCRPC treatment; and to describe 3-year healthcare resource use and costs for all patients and according to first-line treatment.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
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 Dr
Last name Blin
First name Patrick
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

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 signed16/03/2016
Start date of data collection16/04/201814/05/2018
Start date of data analysis01/10/2018
Date of interim report, if expected31/07/2019
Date of final study report31/12/201920/12/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesJanssen-Cilag100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Blin
First name Patrick
Address line 1146 Rue Leo Saignat
Address line 2Service de Pharmacologie 
Address line 3Université de Bordeaux - case 41 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557579563 
Alternative phone number 
Fax number (incl. country code)33557574740 
Email address patrick.blin@u-bordeaux.fr
Public Enquiries
Title Dr 
Last name Blin 
First name Patrick 
Address line 1146 Rue Leo Saignat 
Address line 2Service de Pharmacologie 
Address line 3Université de Bordeaux - case 41 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557579563 
Alternative phone number 
Fax number (incl. country code)33557574740 
Email address patrick.blin@u-bordeaux.fr 
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