Omega-3 Fish Oil Supplement for Prostate Cancer

(RCT-EPAII-BCR Trial)

Overseen By Carole Plante, Inf

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: CHU de Quebec-Universite Laval

Must not be taking: Biologicals, Corticosteroids, Omega-3

Disqualifiers: Metastatic disease, Chemotherapy, Uncontrolled illness, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 months

39 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use omega-3 or any other dietary supplements for the previous 3 months and during the study.

What data supports the effectiveness of the treatment MAG-EPA for prostate cancer?

Research suggests that eicosapentaenoic acid (EPA), a component of MAG-EPA, may help reduce the risk of prostate cancer progression when measured directly in prostate tissue. Additionally, a low-fat diet with fish oil supplementation, which includes omega-3 fatty acids like EPA, showed decreased prostate cancer cell growth in some studies. ^{1 2 3 4 5}

Is omega-3 fish oil safe for humans?

Omega-3 fish oil, including eicosapentaenoic acid (EPA), is generally considered safe for humans and has been studied for its potential protective effects against prostate cancer progression. ^{1 2 3 4 6}

How does the treatment MAG-EPA differ from other prostate cancer treatments?

MAG-EPA, a form of omega-3 fish oil, is unique because it targets prostate cancer by reducing tumor blood vessel growth, which can slow down cancer progression. This approach is different from traditional treatments that may not focus on altering the tumor's blood supply. ^{2 4 7 8 9}

What is the purpose of this trial?

Prostate cancer biochemical recurrence (BCR) occurs in 20-50% of patients following radical prostatectomy or radiotherapy. Due to significant risk of side effects and uncertainty about the benefits, physicians and patients are seeking alternatives to delay androgen deprivation therapy (ADT) for non-metastatic BCR. Long-chain omega-3 fatty acids (LCn3), mainly found in seafood and fatty fish, have beneficial effects against prostate cancer in pre-clinical experimental studies and randomized clinical trials of intermediate prostate cancer outcomes. The current observational evidence also supports testing LCn3 in prostate cancer patients. LCn3 have beneficial effects on inflammation, cardiovascular, psychological, and other outcomes, contrasting sharply with ADT-associated side effects. Investigators propose to conduct a pilot randomized placebo-controlled trial to determine the effects over one year of an innovative LCn3 supplement (5g of omega-3-rich fish oil daily, including 4g of monoglycerides eicosapentaenoic acid (MAG-EPA)) in 40 men experiencing BCR or prostate cancer progression after a curative treatment. This project proposes a simple intervention by dietary supplementation that could eventually help to prevent or delay ADT-related side effects and thus could contribute to diminish the heavy individual and societal burden of prostate cancer. The clinical data generated by this pilot trial will serve as basis for a larger-scale phase II clinical trial.

Research Team

Vincent Fradet, MD, PhD

Principal Investigator

CHU de Québec-Univeristé Laval

Eligibility Criteria

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.

Inclusion Criteria

Provide written informed consent

My prostate cancer diagnosis was confirmed through tissue examination.

I have undergone local treatments for my condition.

Exclusion Criteria

Known allergy to fish or shellfish or sunflower

I have had chemotherapy for my cancer when it came back.

Use of omega-3 or any other dietary supplements for the previous 3 months and during study is not allowed

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 5g/day of omega-3-rich fish oil capsules or placebo for 12 months

12 months

Visits every 3 months for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• MAG-EPA
• Placebo group

Trial Overview 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.

Participant Groups

Group I: MAG-EPA group Experimental Treatment 1 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 group Placebo Group 1 Intervention

5g/day of high-oleic sunflower oil capsules, to be taken once a day, for 12 months.

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

References

1. Greece pubmed.ncbi.nlm.nih.gov

Effects of eicosapentaenoic acid on biochemical failure after radical prostatectomy for prostate cancer. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Prostatic and dietary omega-3 fatty acids and prostate cancer progression during active surveillance. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

The Association of Fatty Acid Levels and Gleason Grade among Men Undergoing Radical Prostatectomy. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Effects of concentrated long-chain omega-3 polyunsaturated fatty acid supplementation before radical prostatectomy on prostate cancer proliferation, inflammation, and quality of life: study protocol for a phase IIb, randomized, double-blind, placebo-controlled trial. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Phase II prospective randomized trial of a low-fat diet with fish oil supplementation in men undergoing radical prostatectomy. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Association of the Omega-3 Index with Incident Prostate Cancer with Updated Meta-Analysis: The Cooper Center Longitudinal Study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Omega-3 Eicosapentaenoic Acid Reduces Prostate Tumor Vascularity. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Omega-3 Fatty Acids Survey in Men under Active Surveillance for Prostate Cancer: from Intake to Prostate Tissue Level. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Prostate cancer risk and consumption of fish oils: a dietary biomarker-based case-control study. [2018]