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

Prostate Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03383016
• Other study ID #: PCa19
• Secondary ID: GRéPEC-17409
• Status: Active, not recruiting
• Start date: June 20, 2013
• Est. completion date: September 2025

Study information

• Verified date: September 2023
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 2053
• Est. completion date: September 2025
• Est. primary completion date: September 23, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epidemiology
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Lifestyle questionnaires

Diagnostic Test:
• Prostate 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.

Locations

Country	Name	City	State
Canada	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

Sponsors (4)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers and modifiable exposure environment	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.	An average of 2 years
Secondary	Study biobank	Biobank of biological samples, clinical data and data from the lifestyle questionnaires	Through study completion, every year up to 2 years