Effects of EPA on Prostate Cancer Cells Proliferation and Quality of Life

NCT02333435 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 2012-1012
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostatectomy; Omega-3 fatty acids; Quality of life; inflammation; cellular proliferation

Outcome Measures

Primary Outcomes (1)

• Change in Prostate Cancer Proliferative Index

  At 6 weeks post study entry, the prostate of the patient will be removed by prostatectomy. The tissue will be preserved in paraffin blocks. The tumour will be identified and the level of Ki-67 in the tumour will be quantified.

  6 weeks

Secondary Outcomes (6)

• Change in Inflammatory mediators levels- Systemic

  6 weeks, 1 year

• Modulation of Inflammatory mediators levels - Prostatic

  6 weeks, 1 year

• Modulation of the Quality of life of patients

  6 weeks, 3, 6, 9 and 12 months post radical prostatectomy

• Modulation of the psychosocial functioning of patients

  6 weeks, 3, 6, 9 and 12 months post radical prostatectomy

• Impact of inflammation on Quality of life

  6 weeks, 3, 6, 9 and 12 months post radical prostatectomy

Other Outcomes (6)

• Fatty acid profiles in red blood cell membranes, change relative to baseline

  6 weeks, 3, 6, 9, 12 months post radical prostatectomy

• Fatty acid profiles in prostate tissue

  6 weeks

• Impact of EPA supplementation on radical prostatectomy complications

  6 weeks

Study Arms (2)

Purified EPA group

EXPERIMENTAL

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

Dietary Supplement: EPA

Placebo group

EXPERIMENTAL

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

Dietary Supplement: Placebo

Interventions

EPA DIETARY_SUPPLEMENT

3g/day of purified EPA , capsules, taken once daily, for 14 months

Purified EPA group

Placebo DIETARY_SUPPLEMENT

3g/day of placebo (high oleic sunflower oil) , capsules, taken once daily, for 14 months

Also known as: High oleic sunflower oil

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prostate cancer (Gleason score \>= 7)
• Patient has chosen to undergo radical prostatectomy
• Patient agrees to stop taking any omega-3 supplements at least 3 months before the start of the study
• Patient has provided informed consent

You may not qualify if:

• Allergy to fish and sunflower
• Suffering from a bipolar disorder

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

Centre de Recherche Clinique et Evaluative en Oncologie - Hotel Dieu de Quebec

Québec, Quebec, G1R 3S1, Canada

Location

Related Publications (3)

• Robitaille K, Guertin MH, Jamshidi A, Xu HW, Hovington H, Pelletier JF, Beaudoin L, Gevariya N, Lacombe L, Tiguert R, Caumartin Y, Dujardin T, Toren P, Lodde M, Racine E, Trudel D, Perigny M, Duchesne T, Savard J, Julien P, Fradet Y, Fradet V. A phase IIb randomized placebo-controlled trial testing the effect of MAG-EPA long-chain omega-3 fatty acid dietary supplement on prostate cancer proliferation. Commun Med (Lond). 2024 Mar 22;4(1):56. doi: 10.1038/s43856-024-00456-4.

  PMID: 38519581 DERIVED

• Savard J, Moussa H, Pelletier JF, Julien P, Lacombe L, Tiguert R, Caumartin Y, Dujardin T, Toren P, Pouliot F, Lodde M, Fradet Y, Robitaille K, Fradet V. Effects of omega-3 supplementation on psychological symptoms in men with prostate cancer: Secondary analysis of a double-blind placebo-controlled randomized trial. Cancer Med. 2023 Oct;12(19):20163-20176. doi: 10.1002/cam4.6598. Epub 2023 Oct 3.

  PMID: 37787025 DERIVED

• Guertin MH, Robitaille K, Pelletier JF, Duchesne T, Julien P, Savard J, Bairati I, Fradet V. 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. BMC Cancer. 2018 Jan 10;18(1):64. doi: 10.1186/s12885-017-3979-9.

  PMID: 29321047 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Inflammation; Hyperplasia

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vincent Fradet, MD, PhD

  Laval University and Hotel Dieu-de-Quebec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: January 7, 2015
• Study Start: February 12, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

CA (1)