Second primary cancers in patients with castration resistant prostate cancer (BOCARP)

Study type

• Study topic:
  Disease /health condition

  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Background Incidence Study
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Prostate cancer metastatic

Population studied

• Short description of the study population:
  Prostate cancer patients with bone metastases (mPC) and among a subgroup of Mpc patients among whom the prostate cancer was castration-resistant (mCRPC).; Patients with valid information on sex, age and the region of residence, a period of at least 12 months of continuous insurance preceding cohort entry, diagnosis of PC (ICD-10 Code C61) in the study period (January 1, 2004 – December 31, 2011), diagnosis of bone metastases (ICD-10 Code C79.5) in the enrolment period (January 1, 2005 – December 31, 2011) were included in the mPC cohort.; Members of the mCRPC cohort should have one of the following in the enrolment period and before or at the same time with bone metastases; a. Discontinuation of the initial chemical castration, change of the agent or modality of the ADT, or start of treatment for advanced PC after the primary ADT ; b. Surgical castration and initiation of ADT treatment; c. Treatment with medication specific to mCRPC or hormone-refractory PC. These are cabazitaxel, enzalutamide, abiraterone, estramustine, docetaxel, mitoxantrone, as well as sipuleucel-T, which are indicated for advanced hormone-refractory PC in Germany
• 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:
  Prostate cancer metastatic patients
• Estimated number of subjects:
  2100

Study design details

• Main study objective:
  Incidence of second primary malignancies in patients with castration resistent prostate cancer.
• Outcomes:
  Incidences of Second primary malignancies are characterized by the following ICD-10 codes: C00-C76, C81-C96, D00-D09, D37-D48. - Up to 10 years, Overall survival - Up to 10 years
• Data analysis plan:
  The incidence of second primary malignancies will be calculated. Overall survival will be described. Details on analysis will be described in the Statistical Analysis Plan (SAP).

Documents

Study results

18044_EU-PAS_Abstract_2018-11-12