Molecular Mechanisms of Dutasteride and Dietary Interventions to Prevent Prostate Cancer and Reduce Its Progression

November 19, 2025 updated by: CHU de Quebec-Universite Laval
The purpose of this study is to determine whether marine omega-3 fatty acids and 5-alpha-reductase inhibitor are effective in the progression of prostate cancer for low-risk prostate cancer patients.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The study has a duration of 1 year for each participant. Subjects will be first assigned to a dietary or a dutasteride intervention that they will consume for the first 6 months. After 6 months, all men will have a combined intervention of dutasteride and diet to complete follow-up of 12 months. This will allow us to study interactive effects.

Dietary intervention consists on a high w-3 long-chain fatty acids diet without supplement and to reduce intake of saturated and trans fatty acids.

Prostatic biopsies will be taken at time of diagnosis and at 6 and 12 months after the beginning of the study. Blood will be drawn before each prostate biopsy session and urine will be collected before each prostate biopsy and after digital rectal examination.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1R 2J6
        • Hotel-Dieu of Quebec
      • Québec, Quebec, Canada, G1V 0A6
        • Institute of nutraceuticals and functional food of Laval University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Low-risk prostatic neoplasms
  • Candidate for active surveillance
  • Informed consent

Exclusion Criteria:

  • Current fish oil supplementation
  • Current NSAID use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietary intervention first
The dietary intervention will be aimed to increase intake of ω-3 long chain fatty acids and to reduce intake of saturated and trans fatty acids.
Other: Dietary intervention first
The dietary intervention will be aimed to increase intake of ω-3 long chain fatty acids and to reduce intake of saturated and trans fatty acids. Three consultations with a nutritionist experienced in clinical trials will be planned over a 6-month period. An additional 2 consultations in the last 6 months with the study nutritionist will be planned for men allocated to the dietary fat intervention arm first. Then, after the 6 months of diet intervention, drug intervention with 5α-Reductase Inhibitor will be add to diet for the 6 following months.
Other Names:
  • Dutasteride
Experimental: Drug intervention first
Intake of 5α-Reductase Inhibitor
Drug: Drug (Dutasteride) intervention first
5α-Reductase Inhibitor will be taken daily in tablet dosage form (0.5 mg) taken orally for 12 months depend of the group. After 6 months of drug intake, dietary fat intervention will be add to treatment for the following 6 months. Three consultations with a nutritionist experienced in clinical trials will be planned over this 6-month period.
Other Names:
  • Dutasteride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of the Interventions on Lipid Metabolism From Blood and Prostatic Microenvironment
Time Frame: 0-6-12 months
In this aim the investigators will measure the effects of the interventions on the fatty acid profile of phospholipids from RBC and from snap frozen prostate tissue. Fatty acid profile from prostatic tissue has never been studied. The investigators aim that change in fatty acid intake will affect fatty acid profile of prostatic tissue. Fatty acid profile from red blood cells will serve as a marker of dietary fatty acid intake. Previous studies have shown that fatty acids profile from RBC differs from the one from muscle tissue and that the dietary effect on RBC fatty acids profile is almost maximal within 6 months.
0-6-12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Interventions on Gene Expression Profile
Time Frame: 0-6-12 months
In this aim the investigators will investigate how the interventions affect prostate tissue gene expression profile determined by cDNA micro-array analysis. We hypothesize that a down-regulation will occur in genes associated with inflammation, androgen synthesis, cell proliferation and angiogenesis pathways. Also, this prospective study provides an opportunity of a retrospective comparison of baseline gene expression patterns from initial prostate biopsy will be correlated with baseline self-reported dietary intake.
0-6-12 months
Effects of Interventions on Hormonal Metabolism
Time Frame: 0-6-12 months
The investigators will initially focus our attention on estrogens (Estrone, Estradiol) and most important androgens and their metabolites (dihydrotestosterone, testosterone, 3-α-diolglucuronide, androsterone glucuronide).
0-6-12 months
Determine the Clinical Utility of Urine-Based Cancer Markers in the Context of Interventions to Reduce Cancer Progression
Time Frame: 0-6-12 months
Although one of the best tumor markers available to monitor disease recurrence after treatment, PSA lacks specificity to monitor patients on active surveillance. The expression of urinary PCA3 (developed in Québec) improves the diagnosis of prostate cancer over standard parameters, including PSA, and the PCA3 score was shown to correlate with grade, stage and tumor volume in prostatectomy specimen. Another gene-based marker, the TMPRSS2-ERG gene fusion transcript, is also associated with tumor aggressiveness and detected in urine.
0-6-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Collaborators

Prostate Cancer Canada

Investigators

  • Principal Investigator: Vincent Fradet, MD, Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2010

Primary Completion (Actual)

December 31, 2016

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 25, 2012

First Submitted That Met QC Criteria

July 30, 2012

First Posted (Estimated)

July 31, 2012

Study Record Updates

Last Update Posted (Estimated)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INAF-2010-H09-10-114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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