NCT03753334Active, not recruitingPhase 2
Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer.
Étude Pilote randomisée de Phase IIB, contrôlée Par placébo, évaluant l'Effet thérapeutique d'Une supplémentation en Omega-3 (Principalement EPA) Chez Des Patients en récidive Biochimique ou en Progression du Cancer de la Prostate.
Source: ClinicalTrials.gov · Last updated 19 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- First submitted
- 14 Nov 2018
- Start date
- 10 Jul 2017
- Primary completion date
- 12 Dec 2023
- Lead sponsor
- CHU de Quebec-Universite Laval
- Diseases
- Prostate cancer
- NCT number
- NCT03753334
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 39
- From 10 Jul 2017 to the primary completion date, 12 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received prior cytotoxic chemotherapy for recurrent disease.
- Patients currently receiving biological response modifiers, or corticosteroids.
- Use of omega-3 or any other dietary supplements for the previous 3 months and during study is not allowed.
Other illness
- Patients with evidence of metastatic disease.
- 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.
- Known allergy to fish or shellfish or sunflower.
Who the study is looking for
- Patients must have a histologically or cytologically confirmed history of adenocarcinoma of the prostate.
- 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.
Age in the registry: 18 years to 100 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre de Recherche Clinique et Évaluative en Oncologie - Hôtel-Dieu de Québec Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.