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.
Haematuria contributes significantly to emergency urology admissions with over 4 per 1000 annual UK emergency admissions and 10% readmitted within 30 days. However, there is limited focus on optimising inpatient pathways internationally. Existing studies highlight a substantial underlying malignancy rate (32%) in patients presenting with visible haematuria, yet many receive inconsistent care, leading to prolonged hospital stays and increased resource use. A systematic review performed by our research group found no large-scale prospective studies have been performed in this area, and little is known about current practice. This study aims to address these gaps by investigating current management practices and their impact on outcomes, with the goal of informing evidence-based guidelines and improving patient care.
The Ward AdmiSsion of Haematuria: an Observational mUlticentre sTudy is an international, multicentre prospective observational study designed to describe the management of patients with unplanned admission to hospital with haematuria under the care of the urology team. The study will use a collaborative methodology using the British Urology Researchers in Surgical Training model. This model delivers international multicentre studies by empowering trainees to lead all aspects of multi-centre clinical studies, building research skills cost-effectively while shaping the future urological consultant workforce. Data on demographics, comorbidities, management practices and outcomes will be collected using a standardised case report form and analysed using multilevel linear regression modelling. Primary outcomes include length of stay, while secondary outcomes cover hospitalisation free survival, mortality, readmission rates at 90 days and resource use. The study was launched in January 2024 and will continue follow-up data collection through December 2025. Patient and public involvement (PPI) has been integral to the study design, ensuring that outcomes reflect patient priorities and that the research addresses key areas of concern.
Ethical and regulatory approvals will be obtained as required in each participating region. In the UK, the study is classified as a service evaluation and does not require individual patient consent. Participating sites must obtain local audit department approval. Data will be collected and stored securely, ensuring patient confidentiality. Results will be disseminated through scientific conferences, peer-reviewed publications and patient advocacy groups.