EPA for Prostate Cancer

(RCT-EPA Trial)

Not currently recruiting at 1 trial location

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: CHU de Quebec-Universite Laval

Disqualifiers: Allergy to fish, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 4

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a specific type of omega-3, called EPA, might benefit people with high-risk prostate cancer. The researchers aim to determine if EPA-rich fish oil supplements can slow cancer growth and improve mental health and quality of life. Participants will receive either fish oil or a placebo (inactive treatment) for 14 months. Men with prostate cancer who have chosen surgery and are not currently taking omega-3 supplements may be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

Do I need to stop taking my current medications for the trial?

The trial requires you to stop taking any omega-3 supplements at least 3 months before it starts. Other medications are not mentioned, so it's unclear if you need to stop them.

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

Research has shown that omega-3 fatty acids from fish, such as EPA, can help reduce inflammation, which might benefit prostate cancer. Some early studies suggest that EPA could slow the growth of prostate tumors, potentially slowing the spread of prostate cancer.

Omega-3 fatty acids are generally safe, and many people use them for heart health. However, some studies have questioned whether high levels of omega-3s could increase prostate cancer risk, but this remains under debate.

In summary, while the effects of this treatment are still being studied, EPA is usually safe for most people. Always discuss any concerns with a healthcare provider before joining a trial. ^{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 hormone therapy, surgery, or radiation, the new treatment under study uses purified EPA, a type of omega-3 fatty acid. Researchers are excited because EPA is believed to have anti-inflammatory properties that might inhibit cancer growth, a unique approach compared to traditional methods. This treatment is administered in capsule form, making it a non-invasive option that could potentially offer fewer side effects and improve patients' quality of life.

What evidence suggests that EPA might be an effective treatment for prostate cancer?

Research has shown that high levels of eicosapentaenoic acid (EPA), a type of omega-3 fatty acid, are linked to a lower risk of prostate cancer progression. One study found that EPA reduced the chance of the cancer becoming more severe. Another study demonstrated that EPA can shrink blood vessels in tumors, potentially slowing cancer growth. EPA also reduces inflammation, which may improve overall health and quality of life for those with prostate cancer. In this trial, participants will receive either purified EPA or a placebo to evaluate its effectiveness in managing prostate cancer. These findings suggest that EPA could be a promising option for managing the disease. ^{5 6 7 8 9}

Who Is on the Research Team?

Vincent Fradet, MD, PhD

Principal Investigator

Laval University and Hotel Dieu-de-Quebec

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Prostate cancer (Gleason score >= 7)

Patient has provided informed consent

You have decided to have your entire prostate gland surgically removed.

Exclusion Criteria

You are allergic to fish or sunflower.

You have bipolar disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Participants receive daily supplementation with 3g of fish oil monoglycerides rich in EPA or placebo for 6 weeks before prostatectomy

6 weeks

1 visit (in-person) for baseline measurements

Treatment

Participants continue daily supplementation with 3g of fish oil monoglycerides rich in EPA or placebo for one year post-prostatectomy

12 months

Regular follow-up visits at 3, 6, 9, and 12 months post-surgery

Follow-up

Participants are monitored for safety, quality of life, and psychosocial functioning after treatment

5 years

Annual visits for long-term monitoring

What Are the Treatments Tested in This Trial?

Interventions

• EPA
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Purified EPA group Experimental Treatment 1 Intervention

3g per day of purified EPA, capsules, to be taken once a day, for 14 months.

Group II: Placebo group Experimental Treatment 1 Intervention

3 g per day of high-oleic sunflower oil capsules, to be taken once a day, for 14 months.

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

Citations

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

A phase IIb randomized placebo-controlled trial testing the ... High prostate eicosapentaenoic fatty acid (EPA) levels were associated with a significant reduction of upgrading to grade group (GG) ≥ 2 ...

2. 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 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1078143924000991

A PHASE IIB RANDOMIZED PLACEBO-CONTROLLED ... High prostate eicosapentaenoic fatty acid (EPA) levels have been associated with a significant reduction of prostate cancer upgrading to grade group (GG) ≥2 ...

4. aacrjournals.org aacrjournals.org/mcr/article/doi/10.1158/1541-7786.MCR-20-0316/81786/am/Omega-3-Eicosapentaenoic-Acid-Reduces-Prostate

Omega-3 Eicosapentaenoic Acid Reduces Prostate Tumor ... MAG-EPA significantly decreased tumor blood vessel diameter (p<0.001). RNA sequencing analysis revealed that MAG-EPA down-regulated angiogenesis- and vascular- ...

5. clinicaltrial.be clinicaltrial.be/en/details/11414?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Effects of EPA on Prostate Cancer Cells Proliferation and... HYPOTHESIS: EPA-rich monoglycerides fish oil (MAG-EPA) has global positive effects on prostate cancer cell proliferation, inflammation and on ...

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

Prostate Cancer Risk And Omega-3 Fatty Acid Intake From ... A study that suggested a risk of prostate cancer in men with high levels of omega-3 fatty acids obtained from these sources.

7. 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 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5736071/

Fish-Derived Omega-3 Fatty Acids and Prostate Cancer Fish-derived omega-3 fatty acids possess anti-inflammatory effects and preclinical data suggest a protective effect on PrCa incidence and progression.

9. lipid.org lipid.org/communications/lipidspin/2014POTPOURRI/11

Omega-3 Fatty Acids and Prostate Cancer - A Study "Spun" ... Eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA) levels were 3.52% in the no-cancer control group, 3.67% in the lowgrade cancer group and 3.74% in the ...