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

NCT01653925 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-11-24

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Prostate Cancer Canada

    collaborator OTHER

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Vincent Fradet, MD · Laval University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-28
Primary Completion
2016-12-31
Completion
2026-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01653925 on ClinicalTrials.gov