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

Condition(s) targeted: Prostatic Neoplasms; Low Grade Prostate Cancer

Intervention: Dietary intervention first (Other); Drug (Dutasteride) intervention first (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Centre Hospitalier Universitaire de Québec, CHU de Québec

Official(s) and/or principal investigator(s):
Vincent Fradet, MD, Principal Investigator, Affiliation: Laval University

Overall contact:
Vincent Fradet, MD, Phone: 418-525-4444, Ext: 15568, Email: vfradet@mac.com

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.

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

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

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

Secondary outcome:

Effect of Interventions on Gene Expression Profile

Effects of Interventions on Hormonal Metabolism

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

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.

Minimum age: 35 Years. Maximum age: 75 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Low-risk prostatic neoplasms

- Candidate for active surveillance

- Informed consent

Exclusion Criteria:

- Current fish oil supplementation

- Current NSAID use

Vincent Fradet, MD, Phone: 418-525-4444, Ext: 15568, Email: vfradet@mac.com

Hotel-Dieu of Quebec, Quebec G1R 2J6, Canada; Recruiting
Vincent Fradet, MD, Principal Investigator

Institute of nutraceuticals and functional food of Laval University, Quebec G1V 0A6, Canada; Recruiting

Starting date: November 2010
Last updated: July 30, 2013