Clinical trial · Observational
Diet, Physical Activity and Related Candidate Biomarkers in Relation to Prostate Cancer Risk (BIOCaPPE)
Interaction Between Environment, Diet, Physical Activities, and Sexual Habits, in the Risk of Prostate Cancer. Validation of Biomarkers to Personalize Preventive Interventions (BIOCaPPE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The risk of prostate cancer is associated with lifestyle habits, such as diet and physical activity. Indeed, results of numerous studies suggest links between obesity, diabetes, inflammation and androgen and estrogen metabolism in the pathogenesis of prostate cancer. The goal of BIOCaPPE study (Biomarkers and Prostate Cancer/ Prevention and Environment) is to identify biomarkers of prostate cancer risk that are potentially modifiable by environmental exposures (e.g. diet and physical activity). A selection of few of the most promising biological markers will be evaluated in a cohort of more than 2000 men at high-risk of prostate cancer. Such biomarkers would provide a practical approach to identify men at high risk of prostate cancer who could benefit from interventions aiming at reducing their risk. The biomarkers would also be useful to monitor the efficacy of the interventions on patient's lifestyle.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epidemiology | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lifestyle questionnaires | Other | — | UNRESOLVED |
| Prostate Biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Men at high-rik of prostate cancer
- description
- Lifestyle questionnaires such as diet questionnaire, physical activities questionnaires, quality of life , Follows up 1 year and 2 years after the enrollment, Anthropometric measures during the first visit , Blood withdrawal for laboratory biomarkers analysis After 2 years, proposal for a 2-year end-of-study prostate biopsy to assess the presence or absence of prostate cancer.
- interventionNames
- Other: Lifestyle questionnaires
- Diagnostic Test: Prostate Biopsy
Primary outcomes (1)
- measure
- Biomarkers and modifiable exposure environment
- timeFrame
- An average of 2 years
- description
- Assess the association between five candidate biological markers potentially modifiable by environmental exposures, mainly diet and physical activity, with the two-year risk of prostate cancer in men at risk for prostate cancer as previously defined.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Group 1: A first negative prostate biopsy within 6 months * Group 2: serum-PSA level between 2.5-10 ng/mL and no prior prostate biopsy Exclusion Criteria: * Prostate cancer * Positive result for transurethral prostatic resection
References
Publications (1)
- DERIVEDMoussa H, Tourigny R, Robitaille K, Bussieres V, Fadel J, Ben Souilah F, Diabate L, Hovington H, Bettan L, Lacombe L, Dujardin T, Lodde M, Toren P, Aprikian A, Saad F, Carmel M, Jeldres C, Lamarche B, Bergeron A, Fradet Y, Fradet V; Network BIOCaPPE. Cohort profile: BioCaPPE (Biomarkers of Prostate Cancer/Prevention and Environment) - a Canadian multicentre prospective study of lifestyle and candidate biomarkers in relation to prostate cancer risk. BMJ Open. 2026 May 28;16(5):e111118. doi: 10.1136/bmjopen-2025-111118. PMID 42209010