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

Laval University

Status: Active, not recruiting

Conditions: Prostatic Neoplasms; Low Grade Prostate Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01653925

INAF-2010-H09-10-114

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Male

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Current fish oil supplementation
• Current NSAID use

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Dietary intervention first

Experimental group

Description:

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.

Treatment:

Other: Dietary intervention first

Drug intervention first

Experimental group

Description:

Intake of 5α-Reductase Inhibitor

Treatment:

Drug: Drug (Dutasteride) intervention first