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Active, Not Recruiting

NCT Number: NCT03383016

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Epidemiology Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Inflammation Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada

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About this study

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:

  • The ratio of ω-3/ ω-6 fatty acid content of red blood cell membranes,
  • Oxidized low density lipoprotein cholesterol
  • Adiponectin
  • Insulin growth factor-1
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle questionnaires

Other

Other names: Blood withdrawal for Laboratory biomarkers analysis, Anthropometric measures

Prostate Biopsy

Diagnostic Test

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.

Other names: follow-up by an urologist

Primary outcomes

  1. Biomarkers and modifiable exposure environment

    Time frame: 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 outcomes

  1. Study biobank

    Time frame: Through study completion, every year up to 2 years

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

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: BIOCaPPE

Important dates

Study start
2013
Primary completion
2022
Study completion
2030
First posted
Dec 26, 2017
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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