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NCT Number: NCT02333435

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hyperplasia Inflammation Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

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

Québec, Quebec, G1R 3S1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

EPA

Dietary Supplement

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

Placebo

Dietary Supplement

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

Other names: High oleic sunflower oil

Primary outcomes

  1. Change in Prostate Cancer Proliferative Index

    Time frame: 6 weeks

    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.

Secondary outcomes

  1. Change in Inflammatory mediators levels- Systemic

    Time frame: 6 weeks, 1 year

    The changes in levels of systemic inflammatory mediators, relative to their baseline levels, at the time of radical prostatectomy and at one year post-radical prostatectomy, will be measured. The levels of mediators will be expressed in pg/mL and quantified using validated techniques.

  2. Modulation of Inflammatory mediators levels - Prostatic

    Time frame: 6 weeks, 1 year

    The differences in the levels of expression of inflammatory mediators between both treatment groups will be measured in the peripheral zone of the prostate before surgical prostate dissection/ischemia. The levels of mediators will be expressed in pg/mL and quantified using validated techniques. Further validation could be performed using immunohistochemistry techniques.

  3. Modulation of the Quality of life of patients

    Time frame: 6 weeks, 3, 6, 9 and 12 months post radical prostatectomy

    Validated questionnaires will be used to measure the modulation of the treatment on Quality of Life of the patients, which will include questions on mood, anxiety levels, sleep and cognition.

  4. Modulation of the psychosocial functioning of patients

    Time frame: 6 weeks, 3, 6, 9 and 12 months post radical prostatectomy

    Validated questionnaires will be used to measure the modulation of the treatment on psychosocial functioning of the patients, which will include questions on mood, anxiety levels, sleep and cognition.

  5. Impact of inflammation on Quality of life

    Time frame: 6 weeks, 3, 6, 9 and 12 months post radical prostatectomy

    The impact of changes in inflammatory mediators levels induced by EPA supplementation on quality of life scores will be measured. To do so, we will use appropriate and powerful statistical tests.

  6. Impact of inflammation on psychosocial functioning

    Time frame: 6 weeks, 3, 6, 9 and 12 months post radical prostatectomy

    The impact of changes in inflammatory mediators levels induced by EPA supplementation and changes in psychosocial functioning scores will be measured. To do so, we will use appropriate and powerful statistical tests.

Other outcomes

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

    Time frame: 6 weeks, 3, 6, 9, 12 months post radical prostatectomy

    The difference of fatty acid levels between both groups, relative to baseline, will be quantified using gas chromatography coupled with mass spectrometry and expressed as relative percentages of total fatty acids.

  2. Fatty acid profiles in prostate tissue

    Time frame: 6 weeks

    The difference of fatty acid levels between both groups at prostatectomy will be quantified using gas chromatography coupled with mass spectrometry and expressed as relative percentages of total fatty acids, and in absolute level (mg per gram of tissue).

  3. Impact of EPA supplementation on radical prostatectomy complications

    Time frame: 6 weeks

    The difference in perioperative bleeding, laboratory tests (hemoglobin, hematocrit and platelets) and surgical complications between both group will be examined at surgery.

  4. Impact of EPA supplementation on cancer aggressiveness

    Time frame: 6 weeks

    Pathological reclassification of cancer grade (ISUP grading system) and stage between the prostate diagnostic biopsy and the prostatectomy specimen will be compared between both groups.

  5. Change on PSA level (ng/mL), relative to baseline

    Time frame: 6 weeks, 3, 6, 9 and 12 months post radical prostatectomy

    PSA change relative to baseline will be measured for both groups.

  6. Impact of EPA supplementation on biochemical recurrence

    Time frame: 5 years post radical prostatectomy

    The biochemical recurrence, defined as a PSA level ≥ 0.2 ng/mL after reaching a non-detectable level at three months post-surgery, will be evaluated for both groups.

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Official study title

Étude randomisée, contrôlée, de Phase II, Effets d'un Supplement d'oméga-3 (EPA) Sur l'Inflammation, la prolifération Cellulaire et la qualité de Vie Chez Des Patients Avec Cancer de la Prostate traités Par Prostatectomie Radicale

Acronym: RCT-EPA

Important dates

Study start
2015
Primary completion
2020
Study completion
2025
First posted
Jan 7, 2015
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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