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Diet, Physical Activity and Related Candidate Biomarkers in Relation to Prostate Cancer Risk (BIOCaPPE)

Active, not recruiting
Conditions
Epidemiology
Prostate Cancer
Interventions
Other: Lifestyle questionnaires
Diagnostic Test: Prostate Biopsy
Registration Number
NCT03383016
Lead Sponsor
CHU de Quebec-Universite Laval
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.

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:

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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
Male
Target Recruitment
2053
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Men at high-rik of prostate cancerLifestyle questionnairesLifestyle 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.
Men at high-rik of prostate cancerProstate BiopsyLifestyle 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.
Primary Outcome Measures
NameTimeMethod
Biomarkers and modifiable exposure environmentAn average of 2 years

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 Outcome Measures
NameTimeMethod
Study biobankThrough study completion, every year up to 2 years

Biobank of biological samples, clinical data and data from the lifestyle questionnaires

Trial Locations

Locations (4)

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

🇨🇦

Montréal, Quebec, Canada

McGill University Health Center

🇨🇦

Montréal, Quebec, Canada

CHU de Quebec- Université Laval

🇨🇦

Québec, Quebec, Canada

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

🇨🇦

Sherbrooke, Quebec, Canada

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