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

NCT01653925 | Active Not Recruiting DMC

• 1 other identifier: INAF-2010-H09-10-114
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostatic Neoplasms; Low Grade Prostate Cancer

Keywords

Prostatic Neoplasms; Low grade prostate cancer

Outcome Measures

Primary Outcomes (1)

• Effects of the Interventions on Lipid Metabolism From Blood and Prostatic Microenvironment

  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 Outcomes (3)

• Effect of Interventions on Gene Expression Profile

  0-6-12 months

• Effects of Interventions on Hormonal Metabolism

  0-6-12 months

• Determine the Clinical Utility of Urine-Based Cancer Markers in the Context of Interventions to Reduce Cancer Progression

  0-6-12 months

Study Arms (2)

Dietary intervention first

EXPERIMENTAL

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

Drug intervention first

EXPERIMENTAL

Intake of 5α-Reductase Inhibitor

Drug: Drug (Dutasteride) intervention first

Interventions

Dietary intervention first OTHER

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.

Also known as: Dutasteride

Dietary intervention first

Drug (Dutasteride) intervention first DRUG

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.

Also known as: Dutasteride

Drug intervention first

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Current fish oil supplementation
• Current NSAID use

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Prostate Cancer Canada: collaborator

Study Sites (2)

Hotel-Dieu of Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Institute of nutraceuticals and functional food of Laval University

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dutasteride; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Vincent Fradet, MD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: July 31, 2012
• Study Start: October 28, 2010
• Primary Completion: December 31, 2016
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

CA (2)