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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Epidemiology, Prostate Cancer

Intervention / Treatment
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* Other: Lifestyle questionnaires
* Diagnostic Test: Prostate Biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Men at high-rik of prostate cancer<br>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. | Other: Lifestyle questionnaires<br> <br> * Other names: Anthropometric measures;Diagnostic Test: Prostate Biopsy<br>* 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.<br>* Other names: follow-up by an urologist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study biobank | Biobank of biological samples, clinical data and data from the lifestyle questionnaires | Through study completion, every year up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer risk, Environmental risk factors, Biomarkers, Inflammation and prostate cancer