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Trial record 4 of 30 for:    prostate cancer prevention | Recruiting, Not yet recruiting, Available Studies

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
Sponsor:
Collaborators:
McGill University Health Center
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

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 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

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 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:

  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.


Study Type : Observational
Estimated Enrollment : 3080 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Other Names:
  • Blood withdrawal for Laboratory biomarkers analysis
  • Anthropometric measures

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




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
serum, plasma, whole blood and blood DNA samples and excess tissue collected from prostate biopsy or prostate surgery


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Eligible participants for this prospective cohort study are men at risk for prostate cancer.
Criteria

Inclusion Criteria:

  • Group 1: serum-PSA level≥ 2.5 ng/L and 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

Information from the National Library of Medicine

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


Contacts
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

Locations
Canada, Quebec
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    helene.leonard.chum@ssss.gouv.qc.ca   
Contact: Brigitte Brisson, IA    514-890-8000 ext 24564    brigitte.brisson.chum@ssss.gouv.qc.ca   
Principal Investigator: Fred SAAD, MD         
McGill University Health Center Recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: Ginette McKercher, MS    514-928-1322    ginette.mckercher@mail.mcgill.ca   
Contact: Nathalie Côté, BSN    514-934-1934 ext 44279    nathalie.cote2@mail.mcgill.ca   
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    emorneau.chus@ssss.gouv.qc.ca   
Contact: Nathalie Goudreau, BAA    819-346-1110 ext 12810    ngoudreau.chus@ssss.gouv.qc.ca   
Principal Investigator: Michel CARMEL, MD         
Sponsors and Collaborators
CHU de Quebec-Universite Laval
McGill University Health Center
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators
Principal Investigator: Yves FRADET, MD CHU de Québec-Université Laval

Responsible Party: CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT03383016     History of Changes
Other Study ID Numbers: PCa19
GRéPEC-17409 ( Other Grant/Funding Number: Cancer Research Society & FRQ-S )
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CHU de Quebec-Universite Laval:
Prostate cancer risk
Environmental risk factors
Biomarkers
Inflammation and prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases