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

Study acronym: RCT-EPAII-BCR
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Secondary endpoints: 3 to 7v8
  2. Study completion date: Dec 2025 to Dec 2026
    • Secondary endpoints: 1 to 3
    v7
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 40 to confirmed 39
    • Primary completion date changed from estimate of Dec 2024 to Dec 12, 2023
    • Site details revised
    v6
  4. Primary completion date: Jun 2023 to Dec 2024
    • Study completion date: Dec 2023 to Dec 2025
    v5
  5. Trial status: Active, Not Recruiting to Recruitingv4 Show 5 more changesShow less
    • Primary completion date: Jun 2022 to Jun 2023
    • Study completion date: Dec 2022 to Dec 2023
    • Interventions: MAG-EPA (Dietary Supplement), Placebo group (Dietary Supplement) to MAG-EPA (Combination Product), Placebo group (Dietary Supplement)
    • Eligibility criteria expanded, about 14 words
    • Site details revised
Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: Dec 2020 to Jun 2022
    • Study completion date: Dec 2021 to Dec 2022
    v3
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 30 to 40
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03753334
Lead Sponsor CHU de Quebec-Universite Laval
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov