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Omega-3 Fatty Acid Supplement

Omega-3 Fish Oil Supplement for Prostate Cancer (RCT-EPAII-BCR 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
Patients must have a histologically or cytologically confirmed history of adenocarcinoma of the prostate
Patients must have a PSA failure defined as PSA of >= 0.5 ng/ml that has increased above nadir following radical prostatectomy (RP) or a PSA increase of 2.0 above post-therapy nadir after radiotherapy (RT) or a PSA increase between 0.05-0.49 ng/ml that has increased above nadir following RP. The maximal PSA value at enrolment must be <5.0 ng/mL after RP and <6 ng/mL after RT
Must not have
Patients who have received prior cytotoxic chemotherapy for recurrent disease
Patients with evidence of metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 9,12 months
Awards & highlights
All Individual Drugs Already Approved

Summary

This trial will test the effects of an omega-3-rich fish oil supplement on men with prostate cancer who are at risk of side effects from androgen deprivation therapy.

Who is the study for?
Men with prostate cancer who've had surgery or radiotherapy but are now seeing a rise in PSA levels, indicating potential cancer return. They must not have metastatic disease, be free from certain medications and supplements for the last 3 months, and cannot have allergies to fish or sunflower.
What is being tested?
The trial is testing if taking a high dose of omega-3-rich fish oil (MAG-EPA) daily can delay the need for more aggressive therapy in men whose prostate cancer may be returning. A placebo group will serve as a comparison to see if there's any benefit.
What are the potential side effects?
While specific side effects aren't listed here, typical ones from omega-3 supplements could include an upset stomach, fishy aftertaste, and increased risk of bleeding. The study excludes those allergic to its components to minimize risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer diagnosis was confirmed through tissue examination.
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My PSA levels have risen after prostate cancer treatment but are below 5 ng/mL after surgery or below 6 ng/mL after radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had chemotherapy for my cancer when it came back.
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My cancer has spread to other parts of my body.
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I am currently taking medications that affect my immune system.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 9,12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 9,12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Prostate-specific antigen (PSA) doubling time from baseline to 12 months.
Secondary study objectives
Fatty acid profiles in red blood cells, changes relative to baseline (time 0).

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MAG-EPA groupExperimental Treatment1 Intervention
5g/day of omega-3-rich fish oil capsules, which include 4g of purified EPA, to be taken once a day, for 12 months.
Group II: Placebo groupPlacebo Group1 Intervention
5g/day of high-oleic sunflower oil capsules, to be taken once a day, for 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Icosapent
FDA approved

Find a Location

Who is running the clinical trial?

CHU de Quebec-Universite LavalLead Sponsor
171 Previous Clinical Trials
109,566 Total Patients Enrolled
12 Trials studying Prostate Cancer
3,802 Patients Enrolled for Prostate Cancer
Vincent Fradet, MD, PhDPrincipal InvestigatorCHU de Québec-Univeristé Laval
1 Previous Clinical Trials
130 Total Patients Enrolled
1 Trials studying Prostate Cancer
130 Patients Enrolled for Prostate Cancer

Media Library

MAG-EPA (Omega-3 Fatty Acid Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03753334 — Phase 2
Prostate Cancer Research Study Groups: Placebo group, MAG-EPA group
Prostate Cancer Clinical Trial 2023: MAG-EPA Highlights & Side Effects. Trial Name: NCT03753334 — Phase 2
MAG-EPA (Omega-3 Fatty Acid Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03753334 — Phase 2
~5 spots leftby Nov 2025
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