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

NAActive, not recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2024

Conditions
Prostatic NeoplasmsLow Grade Prostate Cancer
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.

Trial Locations (2)

G1R 2J6

Hotel-Dieu of Quebec, Québec

G1V 0A6

Institute of nutraceuticals and functional food of Laval University, Québec

All Listed Sponsors
collaborator

Prostate Cancer Canada

OTHER

lead

CHU de Quebec-Universite Laval

OTHER

NCT01653925 - Molecular Mechanisms of Dutasteride and Dietary Interventions to Prevent Prostate Cancer and Reduce Its Progression | Biotech Hunter | Biotech Hunter