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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

Tracking Information
First Submitted Date December 5, 2017
First Posted Date December 26, 2017
Last Update Posted Date January 12, 2018
Actual Study Start Date June 20, 2013
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 21, 2017)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03383016 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 21, 2017)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diet, Physical Activity and Related Candidate Biomarkers in Relation to Prostate Cancer Risk (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)
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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
serum, plasma, whole blood and blood DNA samples and excess tissue collected from prostate biopsy or prostate surgery
Sampling Method Probability Sample
Study Population Eligible participants for this prospective cohort study are men at risk for prostate cancer.
Condition
  • Epidemiology
  • Prostate Cancer
Intervention
  • 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
Study Groups/Cohorts 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.
Interventions:
  • Other: Lifestyle questionnaires
  • Diagnostic Test: Prostate Biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 21, 2017)
3080
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
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
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03383016
Other Study ID Numbers PCa19
GRéPEC-17409 ( Other Grant/Funding Number: Cancer Research Society & FRQ-S )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party CHU de Quebec-Universite Laval
Study Sponsor CHU de Quebec-Universite Laval
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
Investigators
Principal Investigator: Yves FRADET, MD CHU de Québec-Université Laval
PRS Account CHU de Quebec-Universite Laval
Verification Date November 2017