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

35 Years
75 Years
Open (Enrolling)
Prostatic Neoplasms, Low Grade Prostate Cancer

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Trial Information

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

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.

Inclusion Criteria:

- Low-risk prostatic neoplasms

- Candidate for active surveillance

- Informed consent

Exclusion Criteria:

- Current fish oil supplementation

- Current NSAID use

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

0-6-12 months

Safety Issue:


Principal Investigator

Vincent Fradet, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Laval University


Canada: Ethics Review Committee

Study ID:




Start Date:

November 2010

Completion Date:

November 2013

Related Keywords:

  • Prostatic Neoplasms
  • Low Grade Prostate Cancer
  • Prostatic Neoplasms
  • Low grade prostate cancer
  • Neoplasms
  • Prostatic Neoplasms