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

• ClinicalTrials.gov Identifier: NCT01653925
• Recruitment Status: Active, not recruiting
• First Posted: July 31, 2012
• Last Update Posted: February 14, 2023
• Sponsor: CHU de Quebec-Universite Laval
• Collaborator: Prostate Cancer Canada
• Information provided by (Responsible Party): CHU de Quebec-Universite Laval

Tracking Information

• First Submitted Date: July 25, 2012
• First Posted Date: July 31, 2012
• Last Update Posted Date: February 14, 2023
• Actual Study Start Date: November 2010
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 30, 2012)

Effects of the Interventions on Lipid Metabolism From Blood and Prostatic Microenvironment [ Time Frame: 0-6-12 months ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 30, 2012)

• Effect of Interventions on Gene Expression Profile [ Time Frame: 0-6-12 months ]
  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 ]
  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 ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Molecular Mechanisms of Dutasteride and Dietary Interventions to Prevent Prostate Cancer and Reduce Its Progression
• Official Title: Molecular Mechanisms of Dutasteride and Dietary Interventions to Prevent Prostate Cancer and Reduce Its Progression
• Brief 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.

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Prostatic Neoplasms
• Low Grade Prostate Cancer

Intervention

• 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
• 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

Study Arms

• 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.
  Intervention: Other: Dietary intervention first
• Experimental: Drug intervention first
  Intake of 5α-Reductase Inhibitor
  Intervention: Drug: Drug (Dutasteride) intervention first

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: July 30, 2012): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2023
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Current fish oil supplementation
• Current NSAID use

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 35 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01653925
• Other Study ID Numbers: INAF-2010-H09-10-114
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: CHU de Quebec-Universite Laval
• Original Responsible Party: Xavier Moreel, Laval University, stage post-doctoral
• Current Study Sponsor: CHU de Quebec-Universite Laval
• Original Study Sponsor: Laval University
• Collaborators: Prostate Cancer Canada

Investigators

• Principal Investigator: Vincent Fradet, MD; Laval University

• PRS Account: CHU de Quebec-Universite Laval
• Verification Date: February 2023