Diet, Physical Activity and Related Candidate Biomarkers in Relation to Prostate Cancer Risk (BIOCaPPE)
NCT ID: NCT03383016
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
2053 participants
OBSERVATIONAL
2013-06-20
2030-09-30
Brief Summary
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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.
Detailed Description
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Four hospitals in the province of Quebec (Canada) participate to the recruitment of 2,055 men at high-risk for prostate cancer, i.e. men who had a first negative prostate biopsy or whose Prostatic Specific Antigen (PSA) level is between 2.5 and 10 ng/mL without previous prostate biopsy.
The candidate biomarkers that will be tested are:
1. The ratio of ω-3/ ω-6 fatty acid content of red blood cell membranes,
2. Oxidized low density lipoprotein cholesterol
3. Adiponectin
4. Insulin growth factor-1
5. The ratio of dihydrotestosterone glucuronide derivatives over estradiol
A biobank, composed of biological material (whole blood, plasma, serum, lymphocyte layer and excess tissue collected from prostate biopsy or prostate surgery) and clinical data is being created. Questionnaires are used to compile information on socio-demographic aspects, family and personal medical history, quality of life, lifestyle like food and sexual habits.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Lifestyle questionnaires
Prostate Biopsy
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.
Interventions
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Lifestyle questionnaires
Prostate Biopsy
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Group 2: serum-PSA level between 2.5-10 ng/mL and no prior prostate biopsy
Exclusion Criteria
* Positive result for transurethral prostatic resection
18 Years
MALE
No
Sponsors
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McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
OTHER
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
OTHER
CHU de Quebec-Universite Laval
OTHER
Responsible Party
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Principal Investigators
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Vincent FRADET, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHU de Québec-Université Laval
Locations
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Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
McGill University Health Center
Montreal, Quebec, Canada
CHU de Quebec- Université Laval
Québec, Quebec, Canada
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Countries
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Other Identifiers
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GRéPEC-17409
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PCa19
Identifier Type: -
Identifier Source: org_study_id