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

Interaction Between Environment, Diet, Physical Activities, and Sexual Habits, in the Risk of Prostate Cancer. Validation of Biomarkers to Personalize Preventive Interventions (BIOCaPPE)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03383016
Acronym
BIOCaPPE
Enrollment
2053
Registered
2017-12-26
Start date
2013-06-20
Completion date
2030-09-30
Last updated
2025-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidemiology, Prostate Cancer

Keywords

Prostate cancer risk, Environmental risk factors, Biomarkers, Inflammation and prostate cancer

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.

Interventions

OTHERLifestyle questionnaires
DIAGNOSTIC_TESTProstate 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.

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre
CollaboratorOTHER
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
CollaboratorOTHER
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
CollaboratorOTHER
CHU de Quebec-Universite Laval
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Biomarkers and modifiable exposure environmentAn average of 2 yearsAssess 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

MeasureTime frameDescription
Study biobankThrough study completion, every year up to 2 yearsBiobank of biological samples, clinical data and data from the lifestyle questionnaires

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026