Clinical trial NCT03383016: Diet, Physical Activity and Related Candidate Biomarkers in Relation to Prostate Cancer Risk (BIOCaPPE)
Official title: Interaction Between Environment, Diet, Physical Activities, and Sexual Habits, in the Risk of Prostate Cancer. Validation of Biomarkers to Personalize Preventive Interventions (BIOCaPPE)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Epidemiology
Prostate Cancer
Keywords: Prostate cancer risk
Environmental risk factors
Biomarkers
Inflammation and prostate cancer
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
First posted: 2017-12-26
Enrollment: 2053
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible participants for this prospective cohort study are men at risk for 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.

Eligibility criteria: 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

Primary outcomes:
measure: Biomarkers and modifiable exposure environment
timeFrame: An average of 2 years
Secondary outcomes:
measure: Study biobank
timeFrame: Through study completion, every year up to 2 years
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Québec
country: Canada
facility: CHU de Quebec- Université Laval
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: CHU de Québec-Université Laval
name: Vincent FRADET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: