EPA for Prostate Cancer

(RCT-EPA Trial)

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

130 Participants Needed

Trial Summary

What is the purpose of this trial?

Prostate cancer, the most frequently diagnosed cancer among occidental men, is associated with a major individual and societal burden. Although still controversial, the literature suggests that a high consumption of omega-3 fatty acids (ω3) has protective effects against prostate cancer. One of the proposed mechanisms of action of ω3 lies in their anti-inflammatory properties. In addition, there are some observational evidences suggesting an association of ω3 intake with a lower rate of depression in cancer patients. However, no clinical study has tested the efficacy of ω3 supplementation on psychological and quality of life outcomes in that population. Several evidences point to a possible involvement of inflammation in psychological issues. Reducing the systemic inflammatory state may have beneficial impact on the quality of life of these patients. Preliminary work from this team of investigators, in a cohort of patients managed with active surveillance for their low-grade prostate cancer, show a strong inverse association between the risk of prostate cancer progression (to high-grade) and the level of prostatic eicosapentanoic acid (EPA- a type of ω3). HYPOTHESIS: EPA-rich monoglycerides fish oil (MAG-EPA) has global positive effects on prostate cancer cell proliferation, inflammation and on the patient's psychosocial functioning and quality of life. The investigators propose a double blind, randomized controlled clinical trial. 130 consecutive patients suffering from high-risk prostate cancer who choose to be treated by radical prostatectomy will be eligible to this study. The presence of high-grade cancer will be mandatory. The intervention, a daily supplementation with 3g supplement of fish oil monoglycerides rich in EPA, vs. placebo capsules containing high oleic sunflower oil, will start six weeks before the prostatectomy and will continue for one year after surgery. The potential confounding variables will be measured before the start of the intervention: age, anthropometric parameters, stage and clinical and pathological tumor grade (Gleason score), pre-operative level of prostate specific antigen and diet. This project proposes a simple intervention by dietary supplementation that could eventually help to reduce the incidence and/or progression of prostate cancer, and the consequences of its treatment, and thus could contribute to diminish the heavy individual and societal burden of prostate cancer. The clinical data generated by this trial will serve as solid basis for a large-scale phase III clinical trial.

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.

What data supports the effectiveness of the drug EPA for prostate cancer?

Research suggests that eicosapentaenoic acid (EPA), a type of omega-3 fatty acid, may help prevent prostate cancer recurrence by affecting prostate-specific antigen (PSA) levels, which are used to monitor cancer. Additionally, omega-3 fatty acids like EPA have shown promise in improving body composition and reducing inflammation in cancer patients. ^{1 2 3 4 5}

Is eicosapentaenoic acid (EPA) safe for humans?

Eicosapentaenoic acid (EPA), a type of omega-3 fatty acid, has been studied in various contexts, including prostate cancer. While the studies focus on its effects on cancer progression, they do not report any significant safety concerns, suggesting it is generally safe for human use. ^{1 5 6 7 8}

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

EPA (eicosapentaenoic acid), an omega-3 fatty acid, is unique in its potential to reduce prostate cancer progression by decreasing tumor blood vessel growth, which may help slow down the cancer's advancement. This mechanism is different from traditional treatments that often focus on directly targeting cancer cells. ^{4 7 8 9 10}

Research Team

Vincent Fradet, MD, PhD

Principal Investigator

Laval University and Hotel Dieu-de-Quebec

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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

Docosahexaenoic acid enhances the efficacy of docetaxel in prostate cancer cells by modulation of apoptosis: the role of genes associated with the NF-kappaB pathway. [2018]

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

Eicosapentaenoic acid in cancer improves body composition and modulates metabolism. [2015]

4. Greece pubmed.ncbi.nlm.nih.gov

The effect of eicosapentaenoic acid on prostate-specific antigen. [2015]

5. 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]

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

Fatty acid regulation of protein kinase C isoforms in prostate cancer cells. [2007]

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

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

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

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

9. 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]

10. England pubmed.ncbi.nlm.nih.gov

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