EpidemiologyBIOCaPPENCT03383016
Diet, Physical Activity and Related Candidate Biomarkers in Relation to Prostate Cancer Risk (BIOCaPPE)
An observational study of Epidemiology and Prostate Cancer, run by CHU de Quebec-Universite Laval at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Epidemiology, Prostate Cancer
- What is being tested?
- Lifestyle questionnaires and Prostate Biopsy
- How many people
- 2,053 participants
- Where
- 4 sitesCanada
- Study dates
- 20 Jun 2013to Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants for this prospective cohort study are men at risk for prostate cancer.
Who may be able to join
- 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
Who cannot join
- Prostate cancer
- Positive result for transurethral prostatic resection
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9
McGill University Health Center
Montreal, Quebec, H4A 3J1
CHU de Quebec- Université Laval
Québec, Quebec, G1R3S1
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
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)
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).
Read more
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.
Read the 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 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.
- Conditions
- Epidemiology, Prostate Cancer
- Being tested
- Lifestyle questionnaires, Prostate Biopsy
- Keywords
- Prostate cancer risk, Environmental risk factors, Biomarkers, Inflammation and prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle questionnairesOther
Also called Blood withdrawal for Laboratory biomarkers analysis, Anthropometric measures
Prostate BiopsyDiagnostic test
Also called follow-up by an urologist
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Lifestyle questionnaires; Diagnostic Test: Prostate Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: An average of 2 years
Secondary outcomes (1)
Study biobank
Biobank of biological samples, clinical data and data from the lifestyle questionnaires
Measured: Through study completion, every year up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start20 Jun 2013
- Primary completion23 Sep 2022
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpidemiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,053 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Responsible party
- Sponsor
- Investigators
- Vincent FRADET, MD, PhD, Principal investigator, CHU de Québec-Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383016
- Sponsor's protocol ID
- PCa19
- Other IDs
- GRéPEC-17409
- Acronym
- BIOCaPPE
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2017
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Moussa H, Tourigny R, Robitaille K, Bussieres V, Fadel J, Ben Souilah F, Diabate L, Hovington H, Bettan L, Lacombe L, Dujardin T, Lodde M, Toren P, Aprikian A, Saad F, Carmel M, Jeldres C, Lamarche B, Bergeron A, Fradet Y, Fradet V; Network BIOCaPPE. Cohort profile: BioCaPPE (Biomarkers of Prostate Cancer/Prevention and Environment) - a Canadian multicentre prospective study of lifestyle and candidate biomarkers in relation to prostate cancer risk. BMJ Open. 2026 May 28;16(5):e111118. doi: 10.1136/bmjopen-2025-111118.
PubMed 42209010
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03383016
- Acronym / sponsor ID
- BIOCaPPE / PCa19
- Conditions
- Epidemiology, Prostate Cancer
- Keywords
- Prostate cancer risk, Environmental risk factors, Biomarkers, Inflammation and prostate cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,053 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Study start
- 20 Jun 2013 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- Sep 2030 (estimated)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men at high-rik of prostate cancer | – | Other: Lifestyle questionnaires, Diagnostic Test: Prostate BiopsyLifestyle 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants for this prospective cohort study are men at risk for prostate cancer.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Prostate cancer
- Positive result for transurethral prostatic resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle questionnairesAlso: Blood withdrawal for Laboratory biomarkers analysis, Anthropometric measures | Other | Men at high-rik of prostate cancer |
| Prostate BiopsyAlso: follow-up by an urologistPossible 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. | Diagnostic test | Men at high-rik of prostate cancer |
Primary outcome
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.
1 secondary outcome
Study biobank
Time frame: Through study completion, every year up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Derived from this study: PubMed 42209010Moussa H, Tourigny R, Robitaille K, Bussieres V, Fadel J, Ben Souilah F, Diabate L, Hovington H, Bettan L, Lacombe L, Dujardin T, Lodde M, Toren P, Aprikian A, Saad F, Carmel M, Jeldres C, Lamarche B, Bergeron A, Fradet Y, Fradet V; Network BIOCaPPE. Cohort profile: BioCaPPE (Biomarkers of Prostate Cancer/Prevention and Environment) - a Canadian multicentre prospective study of lifestyle and candidate biomarkers in relation to prostate cancer risk. BMJ Open. 2026 May 28;16(5):e111118. doi: 10.1136/bmjopen-2025-111118.
- Individual participant dataSharing planned: Undecided
Related trials for Epidemiology
Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Not yet recruitingObservational study
The GEIR (Grupo español de Ictus Retina) Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion, Central Retinal Artery Occlusion
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health
RecruitingObservational study
Fibrous Dysplasia: An Epidemiological and Correlational Evaluation of Multimodal Data
Fibrous Dysplasia, Fibrous Dysplasia of Bone
RecruitingObservational study
Children and Adults With Chordoma
Chordoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent FRADET, MD, PhD principal investigator
CHU de Québec-Université Laval
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidemiology and Prostate Cancer, run by CHU de Quebec-Universite Laval at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers and modifiable exposure environment (time frame: An average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03383016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.