Prostate CancerPhase 2RCT-EPANCT02333435
Effects of EPA on Prostate Cancer Cells Proliferation and Quality of Life
A Phase 2 study testing EPA in people with Prostate Cancer, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- EPA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteCanada
- Study dates
- 12 Feb 2015to Aug 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Allergy to fish and sunflower
- Suffering from a bipolar disorder
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de Recherche Clinique et Evaluative en Oncologie - Hotel Dieu de Quebec
Québec, Quebec, G1R 3S1
About this study
Official 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
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.
Read more
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
- Being tested
- EPA, Placebo
- Keywords
- Prostatectomy, Omega-3 fatty acids, Quality of life, inflammation, cellular proliferation
- Medical subject headings
- Prostatic Neoplasms, Inflammation, Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPADietary supplement
3g/day of purified EPA , capsules, taken once daily, for 14 months
PlaceboDietary supplement
Also called High oleic sunflower oil
3g/day of placebo (high oleic sunflower oil) , capsules, taken once daily, for 14 months
| Study group | Role | What they receive |
|---|---|---|
| Purified EPA group | Experimental | 3g per day of purified EPA, capsules, to be taken once a day, for 14 months. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (6)
Change in Inflammatory mediators levels- Systemic
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.
Measured: 6 weeks, 1 year
Modulation of Inflammatory mediators levels - Prostatic
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.
Measured: 6 weeks, 1 year
Modulation of the Quality of life of patients
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.
Measured: 6 weeks, 3, 6, 9 and 12 months post radical prostatectomy
Modulation of the psychosocial functioning of patients
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.
Measured: 6 weeks, 3, 6, 9 and 12 months post radical prostatectomy
Impact of inflammation on Quality of life
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.
Measured: 6 weeks, 3, 6, 9 and 12 months post radical prostatectomy
Impact of inflammation on psychosocial functioning
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.
Measured: 6 weeks, 3, 6, 9 and 12 months post radical prostatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study start12 Feb 2015
- Primary completion1 Dec 2020
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Fradet, MD, PhD, Principal investigator, Laval University and Hotel Dieu-de-Quebec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333435
- Sponsor's protocol ID
- 2012-1012
- Acronym
- RCT-EPA
- Status last verified
- Oct 2026
- First submitted
- 17 Dec 2014
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 38519581Savard 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.
PubMed 37787025Guertin 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.
PubMed 29321047