PRostAte Cancer vTe In SwEden: epidemiology and anticoagulation treatment of VTE (PRACTISE)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DABIGATRAN ETEXILATE
• Anatomical Therapeutic Chemical (ATC) code:
  100000144760

  rivaroxaban

  100000144761

  apixaban
• Medical condition to be studied:
  Prostate cancer

Population studied

• Short description of the study population:
  The population will be selected from the PCBaSe 4.0 database that contains patients with PCa as well as PCa-free men from the general population in Sweden who have been frequency-matched to incident cases of PCa by birth year and county of residence. A sub-population will include PCa patients with a cancer-related VTE event.; • PCa patients; - Inclusion criteria; Initially all patients newly diagnosed with PCa between 2007-2016 with at least one year before the end of follow up date (31 December 2017) will be included.; From this population, a sub-population of PCa patients with a first cancer-related VTE event will be selected.; - Exclusion criteria; No exclusions will be made.; • Men without PCa; - Inclusion criteria; All PCa-free men included in PCBaSe who are randomly selected from the general population of Sweden with the same birth year and county of residence of PCa patients diagnosed between 2007- 2016.; - Exclusion criteria; A PC free men diagnosed with a prostate cancer during the follow up will be identified and censured.
• Age groups:
  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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 patients
• Estimated number of subjects:
  99999

Study design details

• Main study objective:
  Among all men with PCa: To describe socio-demographic and clinical characteristics at the date of an incident PCa diagnosis. To estimate the occurrence of cancer-related VTE. To describe the cancer therapies in PCa at the initial time after diagnosis. Among men with PCa and a first cancer-related VT
• Outcomes:
  Patients' socio-demographic and clinical characteristics at the date of an incident PCa diagnosis Incidence rate of cancer-related VTE Cancer therapies in PCa Choice of anticoagulant drug and duration of treatment Occurrence of recurrent VTE events Time between a first cancer-related and a recurrent VTE event Incidence rate of post-VTE bleeding event, Among PCa-free men: Subject's socio-demographic at the time of inclusion into the database Subject's clinical characteristics at the time of inclusion into the database Incidence rate of VTE events
• Data analysis plan:
  Descriptive statistics will be used to define the socio-demographic and clinical characteristics of all PCa patients and PCa-free men, incidence rate of cancer-related VTE events will be also described by Kaplan-Meier curves in different strata.Anticoagulation treatment received by the PCa patients after the first cancer-related VTE event will be reported by type of anticoagulation (LMWH, VKAs and NOACs) and its estimated duration (up to 3 months, 3-6 months, more than 6 months). Among this sub-group of patients, the occurrence (incidence rates) of recurrent VTE and the time to recurrence, post-VTE bleeding leading to hospitalisation, and mortality will be calculated by the type and duration of AC treatment.

Documents

Study results

20653_EU PAS Abstract_Redacted_V1.0_2021-08-23

Study report

20653_Study Report_Redacted_V1.0_2021-08-23