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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether omega-3 fish oil (MAG-EPA) can help manage prostate cancer that returns after initial treatment. The goal is to determine if daily fish oil capsules can delay the need for hormone therapy, which often has severe side effects. Researchers will compare participants to a group taking placebo capsules made of sunflower oil to assess effectiveness. Men who have undergone prostate cancer treatment and are experiencing rising PSA levels (a marker indicating potential cancer recurrence) might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that omega-3 fatty acids, such as those in fish oil, might help protect against prostate cancer. Some studies found that a diet high in omega-3s and low in omega-6s slowed the growth of prostate cancer cells, suggesting possible benefits for prostate health.

Omega-3s are generally considered safe and are already part of many people's diets, found in foods like fish. Studies have shown that people can take fish oil supplements without major problems, though some might experience mild side effects like an upset stomach or a fishy aftertaste.

This trial is in an early stage, focusing on safety and effectiveness. Early-stage studies typically assess basic safety, so information is limited. However, since omega-3s are widely used and have been studied before, there is some confidence in their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Unlike the standard treatments for prostate cancer, which often involve surgery, radiation, or hormone therapy, MAG-EPA is derived from omega-3-rich fish oil. Researchers are excited about MAG-EPA because it contains a high concentration of purified EPA (eicosapentaenoic acid), which is believed to have anti-inflammatory properties that could potentially slow cancer progression. This approach is unique as it targets inflammation, a factor not typically addressed by conventional prostate cancer therapies. Additionally, being a supplement, it offers a non-invasive alternative that could complement existing treatments.

What evidence suggests that this omega-3 fish oil supplement might be an effective treatment for prostate cancer?

This trial will compare the effects of MAG-EPA, an omega-3-rich fish oil supplement, with a placebo. Studies have shown that omega-3 fatty acids can positively impact prostate cancer. In early research, MAG-EPA significantly reduced prostate tumor growth compared to other supplements. Research has also indicated that a higher intake of omega-3s links to a lower chance of developing prostate cancer and a reduced risk of death from it. Additionally, a diet high in omega-3s and low in omega-6s has been shown to slow the growth of prostate cancer cells. These findings suggest that omega-3s, like those in MAG-EPA, may help manage the progression of prostate cancer. ^{2 3 6 7 8}

Who Is on the Research Team?

Vincent Fradet, MD, PhD

Principal Investigator

CHU de Québec-Univeristé Laval

Are You a Good Fit for This Trial?

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

My prostate cancer diagnosis was confirmed through tissue examination.

Provide written informed consent

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.

My cancer has spread to other parts of my body.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. nature.com nature.com/articles/s43856-024-00456-4

A phase IIb randomized placebo-controlled trial testing the ... In pre-clinical prostate cancer models, we showed that MAG-EPA significantly reduced prostate tumor growth compared to control supplements. The ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3828934/

Prostate Cancer Risk And Omega-3 Fatty Acid Intake From ... Harris cited extensive literature on fish intake and higher omega-3 fatty acid intake that demonstrated a lower incidence of prostate cancer incidence and death ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12318741/

Dietary Omega-3 intake may slow prostate cancer ... However, some studies have shown that dietary intake of Omega-3 fatty acids has no effect on the risk of prostate cancer, while eating fish ...

4. uclahealth.org uclahealth.org/news/release/low-omega-6-omega-3-rich-diet-and-fish-oil-may-slow-prostate

A low omega-6, omega-3 rich diet and fish oil may slow ... A diet low in omega-6 and high in omega-3 fatty acids, combined with fish oil supplements, significantly reduced the growth rate of prostate cancer cells in ...

5. auajournals.org auajournals.org/doi/10.1016/j.juro.2018.02.1962

PD42-09 EFFECTS OF OMEGA-3-RICH FISH OIL (MAG ... These first preliminary results suggest that systemic inflammation is modulated by the intervention in PCa patients over time.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10960033/

A phase IIb randomized placebo-controlled trial testing the ... Omega-3 fatty acids, mostly found in fatty fish, might be beneficial by protecting against prostate cancer and its adverse outcomes. We ...

7. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.24.00608

High Omega-3, Low Omega-6 Diet With Fish Oil for Men ... A high omega-3, low omega-6 diet with FO for 1 year resulted in a significant reduction in Ki-67 index, a biomarker for prostate cancer progression, metastasis ...

8. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1623295/full

Dietary Omega-3 intake may slow prostate cancer ... Another meta-analysis on Omega-3 fatty acids and prostate cancer also revealed that there was no significant association between dietary intake or blood Omega-3 ...