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Dutasteride + Dietary Interventions for Prostate Cancer

Waitlist Available
Led By Vincent Fradet, MD
Research Sponsored by CHU de Quebec-Universite Laval
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Candidate for active surveillance
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up 0-6-12 months
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will test whether marine omega-3 fatty acids and 5-alpha-reductase inhibitors can help low-risk prostate cancer patients by slowing the progression of the disease.

Who is the study for?
This trial is for individuals with low-risk prostate cancer who are candidates for active surveillance and have given informed consent. It's not open to those currently taking fish oil supplements or NSAIDs.Check my eligibility
What is being tested?
The study is testing the effectiveness of marine omega-3 fatty acids (dietary intervention) and Dutasteride (a drug), separately, in slowing down the progression of low-risk prostate cancer.See study design
What are the potential side effects?
Dutasteride may cause sexual side effects, such as decreased libido, erectile dysfunction, or ejaculation disorders. Dietary interventions could lead to changes in digestion or allergies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
You are being monitored but not currently receiving treatment for your condition.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-6-12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-6-12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effects of the Interventions on Lipid Metabolism From Blood and Prostatic Microenvironment
Secondary outcome measures
Determine the Clinical Utility of Urine-Based Cancer Markers in the Context of Interventions to Reduce Cancer Progression
Effect of Interventions on Gene Expression Profile
Effects of Interventions on Hormonal Metabolism

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Drug intervention firstExperimental Treatment1 Intervention
Intake of 5α-Reductase Inhibitor
Group II: Dietary intervention firstExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

CHU de Quebec-Universite LavalLead Sponsor
164 Previous Clinical Trials
106,667 Total Patients Enrolled
13 Trials studying Prostate Cancer
3,842 Patients Enrolled for Prostate Cancer
Prostate Cancer CanadaOTHER
9 Previous Clinical Trials
7,406 Total Patients Enrolled
7 Trials studying Prostate Cancer
7,282 Patients Enrolled for Prostate Cancer
Vincent Fradet, MDPrincipal InvestigatorLaval University

Media Library

Dietary intervention Clinical Trial Eligibility Overview. Trial Name: NCT01653925 — N/A
Prostate Cancer Research Study Groups: Dietary intervention first, Drug intervention first
Prostate Cancer Clinical Trial 2023: Dietary intervention Highlights & Side Effects. Trial Name: NCT01653925 — N/A
Dietary intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT01653925 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment recruiting participants who are older than thirty years of age?

"This trial is open to individuals aged 35 and over, up to 75 years of age."

Answered by AI

Is there room to accommodate new participants in this research endeavor?

"This clinical trial is not seeking further candidates. It was first announced in November 2010 and last amended on March 14th 2022. For those looking for similar studies, 1252 trials related to prostate cancer are currently accepting new patients; 6 of which employ Dutasteride as an intervention."

Answered by AI

What is the upper limit of participants in this medical research?

"This medical trial is no longer recruiting. It was initially posted on November 1st 2010 and last revised March 14th 2022. As of now, there are 1252 active clinical trials with a focus on prostate cancer and 6 specifically looking at the efficacy of dutasteride as an intervention that are enrolling patients."

Answered by AI

What criteria must be met for a patient to qualify for this clinical research?

"To enroll in this study, patients aged 35-75 with prostate cancer must meet the following criteria: low risk prostatic neoplasms, candidate for active surveillance, and signing of an informed consent. A total of 120 participants are needed."

Answered by AI
~8 spots leftby Feb 2025