Aspirin use and prostate cancer mortality in men with high grade prostate cancer

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Assessment of chemoprevention
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ACETYLSALICYLIC ACID
• Medical condition to be studied:
  Neoplasm prostate

Population studied

• Short description of the study population:
  Men aged 50-80 years at the time of prostate cancer diagnosis (ICD-O, C61), diagnosed as having a tumour with Gleason Score histology > 7 between 1st January 2001 and 31st December 2006
• Age groups:
  • 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:
  Patients with high grade prostate tumours
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  This study aims to examine the associations between aspirin use and prostate cancer mortality in men diagnosed with high grade prostate tumours.
• Outcomes:
  Prostate cancer death
• Data analysis plan:
  Linked National Cancer Registry of Ireland data (2001-2006) and prescription claims data from the Republic of Ireland will be used to carry out this study (NCRI-PCRS database). This study is restricted to men aged between 50 and 80 years at diagnosis with prostate cancer of Gleason Score > 7. Men diagnosed with prostate cancer at death/autopsy, or men with another invasive cancer, excluding non-melanoma skin cancer, prior to their prostate cancer diagnosis will be excluded. Cox proportional hazards models with 95% Confidence intervals will be used to estimate Hazard Ratios (HR) for the association between aspirin use in the year prior to diagnosis and prostate cancer specific mortality. Stratification by tumour stage will determine a multiplicative interaction of the association between aspirin exposure and prostate cancer in localised compared to advanced tumours using ratio of HR (rHR).