The BioCaPPE (Biomarkers of Prostate Cancer/Prevention and Environment) study is a multicentre prospective observational cohort designed to identify biomarkers associated with prostate cancer (PCa) risk that may be modifiable through lifestyle factors. This paper describes the cohort, along with the data and bio-samples available for future studies in PCa risk assessment.

Canadian men at risk of PCa were enrolled based on one of two criteria (1) negative first prostate biopsy within 6 months from enrolment (Group 1); or (2) a prostate-specific antigen (PSA) blood level between 2.5 and 10 ng/mL without prior prostate biopsy (Group 2). At baseline, blood samples and comprehensive data were collected. PCa incidence and lifestyle factors were updated for all participants over 2 years, with extended follow-up for those who provided additional consent.

Recruitment was conducted across four health centres in Quebec, Canada. A total of 2053 men were enrolled—1499 in Group 1 and 554 in Group 2. All participants completed the initial visit, which included collection of medical and family history, anthropometric measurements, demographic information, dietary and alcohol intake, physical activity, tobacco use, medication use, and quality of life assessments, and candidate biomarker measurements. At the 2-year mark, 7.2% of participants had developed PCa; this figure has since increased to 15.3% (median follow-up: 6.1 years). Additionally, 84% (n=1718) consented to ongoing annual follow-up.

This large, prospective cohort of men at risk of PCa offers valuable resources for risk stratification and primary prevention. The BioCaPPE biosamples and data are available to support the identification of lifestyle-related biomarkers associated with PCa risk in this population.

ClinicalTrials.gov Identifier: NCT03383016.