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ACTIVE NOT RECRUITING
NCT01653925
NA

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

Sponsor: CHU de Quebec-Universite Laval

View on ClinicalTrials.gov

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.

Key Details

Gender

MALE

Age Range

35 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2010-10-28

Completion Date

2026-12

Last Updated

2025-11-24

Healthy Volunteers

No

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.

Locations (2)

Hotel-Dieu of Quebec

Québec, Quebec, Canada

Institute of nutraceuticals and functional food of Laval University

Québec, Quebec, Canada