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 type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Prostate cancer

Population studied

• Short description of the study population:
  Patients with metastatic castration-resistant prostate cancer (mCRPC), aged 40 years or older, initiated docetaxel or abiraterone acetate as the first-line treatment identified from SNDS nation-wide claims and hospital databases between 2012 and 2014.; Inclusion criteria: ; • Men of 40 years old and over, alive on the first day of the inclusion period,; • And affiliated to the healthcare insurance system “Régime Général” during the study period,; • And having mCRPC during the inclusion period,; • And initiating a first mCRPC specific treatment during the inclusion period,; • And without any mCRPC specific treatment during the 5-year history before.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Metastatic castrate resistant prostate cancer patients
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  To describe first-line treatment for patients with incident mCRPC in 2012 and 2014 and then subsequent-line treatments during a 3-year follow-up.
• Outcomes:
  mCRPC 1st-line therapy. mCRPC is defined as patients with prostate cancer and: -metastatic, based on hospitalisation for metastases, or specific treatment for metastases (e.g. radiofrequency), or metastases specific drug dispensing (e.g. denosumab) -castration-resistant, based on specific drug for prostate cancer (androgen deprivation), CRPC (estramustine), mCRPC (hormonotherapy, cabazitaxel), Overall survival: death at 3-year of follow-up. Complication: hospitalisation with main diagnosis of sepsis, cardiovascular events, adrenal insufficiency, hepatitis fulminant, acute hepatic failure, acute renal failure, rhabdomyolysis, fractures, etc.
• Data analysis plan:
  The following analyses will be performed for each cohort using the total population and according to mCRPC first-line treatment: - Definition of mCRPC stage using preliminary EGB analyses, - A flow chart depicting the number of patients and sequences of treatment available in the database satisfying the cohort criteria and follow-up duration, - Description of baseline characteristics, comorbidities and prostate cancer history, - Description of first-line treatment for mCRPC patients in 2012 and 2014 and then subsequent-line treatments during a 3-year follow-up, - Estimation of overall survival using time to events methods, - Description of complications that could be related to mCRPC treatment, - Description of the 3-year healthcare resources use and costs.

Documents

Study results

CAMERRA Poster_2020_ASCO_v1.0 final-edited on 20201021

Study publications

Thurin NH, Rouyer M, Gross-Goupil M, Rebillard X, Soulié M, Haaser T, Roumiguié…

Thurin NH, Rouyer M, Jové J, Gross-Goupil M, Haaser T, Rébillard X, Soulié M, d…