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.

Study Timeline

• Study Start: 2013-06-20
• Study First Submitted: 2017-12-05
• Study First Submitted QC: 2017-12-21
• Study First Posted: 2017-12-26
• Primary Completion: 2022-09-23
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-21
• Study Completion: 2025-09

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

Group	Intervention	Description
Men at high-rik of prostate cancer	Lifestyle questionnaires	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.
Men at high-rik of prostate cancer	Prostate Biopsy	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.

Primary Outcome Measures

Name	Time	Method
Biomarkers and modifiable exposure environment	An 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

Name	Time	Method
Study biobank	Through 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