Trial | NCT01653925  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Intervention/Treatment

    dutasteride ...

  • Study Participants

    120
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.
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.
Study Started
Nov 30
2010
Primary Completion
Dec 31
2023
Anticipated
Study Completion
Dec 31
2023
Anticipated
Last Update
Feb 14
2023

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.

  • Other names: Dutasteride

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.

  • Other names: Dutasteride

Drug intervention first Experimental

Intake of 5α-Reductase Inhibitor

Dietary intervention first Experimental

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.

Criteria 

Inclusion Criteria:

Low-risk prostatic neoplasms
Candidate for active surveillance
Informed consent

Exclusion Criteria:

Current fish oil supplementation
Current NSAID use
No Results Posted