Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer.
NCT ID: NCT03753334
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
39 participants
INTERVENTIONAL
2017-07-10
2026-12-31
Brief Summary
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Investigators propose to conduct a pilot randomized placebo-controlled trial to determine the effects over one year of an innovative LCn3 supplement (5g of omega-3-rich fish oil daily, including 4g of monoglycerides eicosapentaenoic acid (MAG-EPA)) in 40 men experiencing BCR or prostate cancer progression after a curative treatment.
This project proposes a simple intervention by dietary supplementation that could eventually help to prevent or delay ADT-related side effects and thus could contribute to diminish the heavy individual and societal burden of prostate cancer. The clinical data generated by this pilot trial will serve as basis for a larger-scale phase II clinical trial.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MAG-EPA group
5g/day of omega-3-rich fish oil capsules, which include 4g of purified EPA, to be taken once a day, for 12 months.
MAG-EPA
5g/day of omega-3-rich fish oil including 4g of purified monoglycerides EPA, capsules, taken once daily, for 12 months
Placebo group
5g/day of high-oleic sunflower oil capsules, to be taken once a day, for 12 months.
Placebo group
5g/day of placebo (high oleic sunflower oil), capsules, taken once daily, for 12 months
Interventions
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MAG-EPA
5g/day of omega-3-rich fish oil including 4g of purified monoglycerides EPA, capsules, taken once daily, for 12 months
Placebo group
5g/day of placebo (high oleic sunflower oil), capsules, taken once daily, for 12 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have a PSA failure defined as PSA of \>= 0.5 ng/ml that has increased above nadir following radical prostatectomy (RP); or a PSA increase of 2.0 above post-therapy nadir after radiotherapy (RT); or a PSA increase between 0.05-0.49 ng/ml that has increased above nadir following RP. The maximal PSA value at enrolment must be \<5.0 ng/mL after RP and \<6 ng/mL after RT.
* PSA value must be increasing based on three consecutive measurements each separated by at least 4 weeks prior to enrolment to this study.
* Patients may have received any number of local therapies (RP, external beam RT or brachytherapy).
* Provide written informed consent.
Exclusion Criteria
* Patients who have received prior cytotoxic chemotherapy for recurrent disease.
* Patients currently receiving biological response modifiers, or corticosteroids.
* Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situations that would limit compliance with study requirements.
* Use of omega-3 or any other dietary supplements for the previous 3 months and during study is not allowed.
* Known allergy to fish or shellfish or sunflower.
18 Years
100 Years
MALE
No
Sponsors
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CHU de Quebec-Universite Laval
OTHER
Responsible Party
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Principal Investigators
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Vincent Fradet, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHU de Québec-Univeristé Laval
Locations
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Centre de Recherche Clinique et Évaluative en Oncologie - Hôtel-Dieu de Québec
Québec, Quebec, Canada
Countries
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Other Identifiers
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2017-3407
Identifier Type: -
Identifier Source: org_study_id