Therapeutic 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 (CAMERRA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48948
• EU PAS number:
  EUPAS21285
• Study ID:
  48948
• Official title and acronym:
  Therapeutic 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 (CAMERRA)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Prostate 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.
• Study status:
  Finalised

Research institution and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

Contact details

Patrick Blin

Study contact

[e-mail]

Patrick Blin

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual: 16/03/2016

Data collection

Planned: 16/04/2018

Actual: 14/05/2018

Start date of data analysis

Actual: 01/10/2018

Date of interim report, if expected

Actual: 31/07/2019

Date of final study report

Planned: 31/12/2019

Actual: 20/12/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen-Cilag

Study protocol

Initial protocol

CAMERRA_Protocole_vuCEREES v2.1_20180126 vf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable