Diet, Physical Activity and Related Candidate Biomarkers in Relation to Prostate Cancer Risk (BIOCaPPE) (BIOCaPPE)
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|ClinicalTrials.gov Identifier: NCT03383016|
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : January 12, 2018
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 3000 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.
|Condition or disease||Intervention/treatment|
|Epidemiology Prostate Cancer||Other: Lifestyle questionnaires Diagnostic Test: Prostate Biopsy|
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 3,080 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
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||3080 participants|
|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)|
|Actual Study Start Date :||June 20, 2013|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
Men at high-rik of prostate cancer
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
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.
Other Name: follow-up by an urologist
- 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.
- 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
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383016
|Contact: Laurence V. BETTAN, Ph.D||418-525-4444 ext 16848||Laurence.Bettan@crchudequebec.ulaval.ca|
|Contact: Alain BERGERON, Ph.D||418-525-4444 ext 15530||Alain.Bergeron@crchudequebec.ulaval.ca|
|Centre de Recherche du Centre Hospitalier de l'Université de Montréal||Recruiting|
|Montréal, Quebec, Canada, H2X 0A9|
|Contact: Hélène Léonard, MS 514-890-8000 ext 26161 firstname.lastname@example.org|
|Contact: Brigitte Brisson, IA 514-890-8000 ext 24564 email@example.com|
|Principal Investigator: Fred SAAD, MD|
|McGill University Health Center||Recruiting|
|Montréal, Quebec, Canada, H4A 3J1|
|Contact: Ginette McKercher, MS 514-928-1322 firstname.lastname@example.org|
|Contact: Nathalie Côté, BSN 514-934-1934 ext 44279 email@example.com|
|Principal Investigator: Armen APRIKIAN, MD|
|CHU de Quebec- Université Laval||Recruiting|
|Québec, Quebec, Canada, G1R3S1|
|Contact: Laurence V Bettan, Ph.D 418-525-4444 ext 16848 Laurence.Bettan@crchudequebec.ulaval.ca|
|Contact: Alain Bergeron, Ph.D 418-525-4444 ext 15530 Alain.Bergeron@crchudequebec.ulaval.ca|
|Principal Investigator: Yves Fradet, MD|
|Centre de recherche du Centre hospitalier universitaire de Sherbrooke||Recruiting|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Contact: Elsie Morneau, BSN 819-346-1110 ext 12827 firstname.lastname@example.org|
|Contact: Nathalie Goudreau, BAA 819-346-1110 ext 12810 email@example.com|
|Principal Investigator: Michel CARMEL, MD|
|Principal Investigator:||Yves FRADET, MD||CHU de Québec-Université Laval|