- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03383016
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)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The main objective of the proposed research project is to assess the association between five candidate biological markers potentially modifiable by environmental exposures (diet and physical activity) and the two-year risk of prostate cancer in a newly recruited cohort of men at high-risk of prostate cancer showing no evidence of cancer.
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:
- The ratio of ω-3/ ω-6 fatty acid content of red blood cell membranes,
- Oxidized low density lipoprotein cholesterol
- Adiponectin
- Insulin growth factor-1
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Quebec
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Montréal, Quebec, Canada, H2X 0A9
- Centre de Recherche du Centre Hospitalier de l'Universite de Montreal
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Montréal, Quebec, Canada, H4A 3J1
- McGill University Health Center
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Québec, Quebec, Canada, G1R3S1
- CHU de Quebec- Université Laval
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Sherbrooke, Quebec, Canada, J1H 5N4
- Centre de recherche du Centre hospitalier Universitaire de Sherbrooke
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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Other Names:
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biomarkers and modifiable exposure environment
Time Frame: An average of 2 years
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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.
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An average of 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Study biobank
Time Frame: Through study completion, every year up to 2 years
|
Biobank of biological samples, clinical data and data from the lifestyle questionnaires
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Through study completion, every year up to 2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Vincent FRADET, MD, PhD, CHU de Quebec-Universite Laval
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCa19
- GRéPEC-17409 (Other Grant/Funding Number: Cancer Research Society & FRQ-S)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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