Diet, Physical Activity and Related Candidate Biomarkers in Relation to Prostate Cancer Risk (BIOCaPPE)
BIOCaPPE
Interaction Between Environment, Diet, Physical Activities, and Sexual Habits, in the Risk of Prostate Cancer. Validation of Biomarkers to Personalize Preventive Interventions (BIOCaPPE)
2 other identifiers
observational
2,053
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2013
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2013
CompletedFirst Submitted
Initial submission to the registry
December 5, 2017
CompletedFirst Posted
Study publicly available on registry
December 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2030
ExpectedDecember 30, 2025
December 1, 2025
9.3 years
December 5, 2017
December 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biomarkers and modifiable exposure environment
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.
An average of 2 years
Secondary Outcomes (1)
Study biobank
Through study completion, every year up to 2 years
Study Arms (1)
Men at high-rik of prostate cancer
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.
Interventions
Possible follow-up by an urologist at 1 year and 2 years after recruitment. After 2 years, proposal for a 2-year end-of-study prostate biopsy to assess the presence or absence of prostate cancer.
Eligibility Criteria
Eligible participants for this prospective cohort study are men at risk for prostate cancer.
You may qualify if:
- 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
You may not qualify if:
- Prostate cancer
- Positive result for transurethral prostatic resection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9, Canada
McGill University Health Center
Montreal, Quebec, H4A 3J1, Canada
CHU de Quebec- Université Laval
Québec, Quebec, G1R3S1, Canada
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
Biospecimen
serum, plasma, whole blood and blood DNA samples and excess tissue collected from prostate biopsy or prostate surgery
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent FRADET, MD, PhD
CHU de Québec-Université Laval
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2017
First Posted
December 26, 2017
Study Start
June 20, 2013
Primary Completion
September 23, 2022
Study Completion (Estimated)
September 1, 2030
Last Updated
December 30, 2025
Record last verified: 2025-12