Spots Global Cancer Trial Database for Molecular Mechanisms of Dutasteride and Dietary Interventions to Prevent Prostate Cancer and Reduce Its Progression

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Trial Identification

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

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

Study ID: NCT01653925

Conditions

Prostatic Neoplasms

Low Grade Prostate Cancer

Interventions

Dietary intervention first

Drug (Dutasteride) intervention first

Study Description

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.

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.