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Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer.

NCT03753334 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-12-19

No results posted yet for this study

Summary

Prostate cancer biochemical recurrence (BCR) occurs in 20-50% of patients following radical prostatectomy or radiotherapy. Due to significant risk of side effects and uncertainty about the benefits, physicians and patients are seeking alternatives to delay androgen deprivation therapy (ADT) for non-metastatic BCR. Long-chain omega-3 fatty acids (LCn3), mainly found in seafood and fatty fish, have beneficial effects against prostate cancer in pre-clinical experimental studies and randomized clinical trials of intermediate prostate cancer outcomes. The current observational evidence also supports testing LCn3 in prostate cancer patients. LCn3 have beneficial effects on inflammation, cardiovascular, psychological, and other outcomes, contrasting sharply with ADT-associated side effects.

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.

Conditions

Interventions

COMBINATION_PRODUCT

MAG-EPA

5g/day of omega-3-rich fish oil including 4g of purified monoglycerides EPA, capsules, taken once daily, for 12 months

DIETARY_SUPPLEMENT

Placebo group

5g/day of placebo (high oleic sunflower oil), capsules, taken once daily, for 12 months

Sponsors & Collaborators

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Vincent Fradet, MD, PhD · CHU de Québec-Univeristé Laval

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-10
Primary Completion
2023-12-12
Completion
2026-12-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03753334 on ClinicalTrials.gov