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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Centre Hospitalier Universitaire de Québec, CHU de Québec
Sponsor:
Collaborator:
Prostate Cancer Canada Network
Information provided by (Responsible Party):
Xavier Moreel, Laval University
ClinicalTrials.gov Identifier:
NCT01653925
First received: July 25, 2012
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Prostatic Neoplasms
Low Grade Prostate Cancer
Other: Dietary intervention first
Drug: Drug (Dutasteride) intervention first

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Molecular Mechanisms of Dutasteride and Dietary Interventions to Prevent Prostate Cancer and Reduce Its Progression

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Primary Outcome Measures:
  • Effects of the Interventions on Lipid Metabolism From Blood and Prostatic Microenvironment [ Time Frame: 0-6-12 months ] [ Designated as safety issue: No ]
    In this aim the investigators will measure the effects of the interventions on the fatty acid profile of phospholipids from RBC and from snap frozen prostate tissue. Fatty acid profile from prostatic tissue has never been studied. The investigators aim that change in fatty acid intake will affect fatty acid profile of prostatic tissue. Fatty acid profile from red blood cells will serve as a marker of dietary fatty acid intake. Previous studies have shown that fatty acids profile from RBC differs from the one from muscle tissue and that the dietary effect on RBC fatty acids profile is almost maximal within 6 months.


Secondary Outcome Measures:
  • Effect of Interventions on Gene Expression Profile [ Time Frame: 0-6-12 months ] [ Designated as safety issue: No ]
    In this aim the investigators will investigate how the interventions affect prostate tissue gene expression profile determined by cDNA micro-array analysis. We hypothesize that a down-regulation will occur in genes associated with inflammation, androgen synthesis, cell proliferation and angiogenesis pathways. Also, this prospective study provides an opportunity of a retrospective comparison of baseline gene expression patterns from initial prostate biopsy will be correlated with baseline self-reported dietary intake.

  • Effects of Interventions on Hormonal Metabolism [ Time Frame: 0-6-12 months ] [ Designated as safety issue: No ]
    The investigators will initially focus our attention on estrogens (Estrone, Estradiol) and most important androgens and their metabolites (dihydrotestosterone, testosterone, 3-α-diolglucuronide, androsterone glucuronide).

  • Determine the Clinical Utility of Urine-Based Cancer Markers in the Context of Interventions to Reduce Cancer Progression [ Time Frame: 0-6-12 months ] [ Designated as safety issue: No ]
    Although one of the best tumor markers available to monitor disease recurrence after treatment, PSA lacks specificity to monitor patients on active surveillance. The expression of urinary PCA3 (developed in Québec) improves the diagnosis of prostate cancer over standard parameters, including PSA, and the PCA3 score was shown to correlate with grade, stage and tumor volume in prostatectomy specimen. Another gene-based marker, the TMPRSS2-ERG gene fusion transcript, is also associated with tumor aggressiveness and detected in urine.


Estimated Enrollment: 120
Study Start Date: November 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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 Name: Dutasteride
Experimental: Drug intervention first
Intake of 5α-Reductase Inhibitor
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 Name: Dutasteride

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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Current fish oil supplementation
  • Current NSAID use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653925

Contacts
Contact: Vincent Fradet, MD 418-525-4444 ext 15568 vfradet@mac.com
Contact: Yves Fradet, MD 418-525-4444 ext 15575 yves.fradet@crhdq.ulaval.ca

Locations
Canada
Hotel-Dieu of Quebec Recruiting
Quebec, Canada, G1R 2J6
Principal Investigator: Vincent Fradet, MD         
Institute of nutraceuticals and functional food of Laval University Recruiting
Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU de Québec
Prostate Cancer Canada Network
Investigators
Principal Investigator: Vincent Fradet, MD Laval University
  More Information

No publications provided

Responsible Party: Xavier Moreel, stage post-doctoral, Laval University
ClinicalTrials.gov Identifier: NCT01653925     History of Changes
Other Study ID Numbers: INAF-2010-H09-10-114
Study First Received: July 25, 2012
Last Updated: July 30, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
Prostatic Neoplasms
Low grade prostate cancer

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014