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Omega-3 Fatty Acid

EPA for Prostate Cancer (RCT-EPA Trial)

Phase 2
Waitlist Available
Led By Vincent Fradet, MD, PhD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 1 year

Summary

This trial will test if fish oil monoglycerides rich in EPA has global positive effects on prostate cancer cell proliferation, inflammation and on the patient's psychosocial functioning and quality of life, in men with high-risk prostate cancer.

Who is the study for?
Men with high-risk prostate cancer (Gleason score >= 7) who have chosen surgery to remove the prostate and are not taking omega-3 supplements can join. They must consent to the study but cannot participate if they're allergic to fish or sunflower, or have bipolar disorder.
What is being tested?
The trial is testing whether a daily dose of EPA-rich fish oil can slow down cancer cell growth, reduce inflammation, and improve mental health and life quality compared to a placebo. Participants will be randomly assigned either the supplement or placebo for one year around their surgery.
What are the potential side effects?
Potential side effects may include typical reactions associated with dietary supplements such as digestive discomfort. Since it's an omega-3 supplement, those with fish allergies (excluded from this trial) would typically risk allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Prostate Cancer Proliferative Index
Secondary study objectives
Change in Inflammatory mediators levels- Systemic
Impact of inflammation on Quality of life
Impact of inflammation on psychosocial functioning
+3 more
Other study objectives
Change on PSA level (ng/mL), relative to baseline
Fatty acid profiles in prostate tissue
Fatty acid profiles in red blood cell membranes, change relative to baseline
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Purified EPA groupExperimental Treatment1 Intervention
3g per day of purified EPA, capsules, to be taken once a day, for 14 months.
Group II: Placebo groupExperimental Treatment1 Intervention
3 g per day of high-oleic sunflower oil capsules, to be taken once a day, for 14 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EPA
2015
N/A
~1990
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

CHU de Quebec-Universite LavalLead Sponsor
171 Previous Clinical Trials
109,475 Total Patients Enrolled
12 Trials studying Prostate Cancer
3,711 Patients Enrolled for Prostate Cancer
Vincent Fradet, MD, PhDPrincipal InvestigatorLaval University and Hotel Dieu-de-Quebec
1 Previous Clinical Trials
39 Total Patients Enrolled
1 Trials studying Prostate Cancer
39 Patients Enrolled for Prostate Cancer

Media Library

EPA (Omega-3 Fatty Acid) Clinical Trial Eligibility Overview. Trial Name: NCT02333435 — Phase 2
Prostate Cancer Research Study Groups: Placebo group, Purified EPA group
Prostate Cancer Clinical Trial 2023: EPA Highlights & Side Effects. Trial Name: NCT02333435 — Phase 2
EPA (Omega-3 Fatty Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02333435 — Phase 2
~12 spots leftby Nov 2025
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