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AzTrials

Prostate CancerPhase 2RCT-EPAII-BCRNCT03753334

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

A Phase 2 study testing MAG-EPA in people with Prostate Cancer, run by CHU de Quebec-Universite Laval at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
MAG-EPA
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
1 siteCanada
Study dates
10 Jul 2017to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 to 100 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Patients with evidence of metastatic disease.
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre de Recherche Clinique et Évaluative en Oncologie - Hôtel-Dieu de Québec

    Québec, Quebec, G1R 3S1

Other trials in Canada

About this study

Official title: 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.

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
Prostate Cancer
Being tested
MAG-EPA, Placebo group
Keywords
Biochemical recurrence (BCR), Androgen-deprivation therapy (ADT), PSA doubling time, Quality of life, Omega-3 fatty acids, Biomarkers, Prostate cancer progression, PSA kinetics
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MAG-EPACombination product

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

  • Placebo groupDietary supplement

    Also called High oleic sunflower oil

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

Study groups in NCT03753334
Study groupRoleWhat they receive
MAG-EPA groupExperimental5g/day of omega-3-rich fish oil capsules, which include 4g of purified EPA, to be taken once a day, for 12 months.
Receives: Combination Product: MAG-EPA
Placebo groupPlacebo comparator5g/day of high-oleic sunflower oil capsules, to be taken once a day, for 12 months.
Receives: Dietary Supplement: Placebo group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prostate-specific antigen (PSA) doubling time from baseline to 12 months.

    Efficacy of a one-year MAG-EPA supplementation versus placebo on PSA kinetics will be evaluated based on the comparison of PSA doubling time from baseline to 12 months. The investigators will measure PSA level every three months and calculate PSA doubling time at 12 months (using a linear regression approach) after randomisation using the randomisation PSA value as the starting point. PSA slope will be defined as the linear regression line of the natural log of PSA (in ng/mL) against time (in months). PSA doubling time will be defined as the natural log of 2 divided by the PSA slope.

    Measured: 12 months

Secondary outcomes (7)

  1. Fatty acid profiles in red blood cells, changes relative to baseline (time 0).

    The changes of fatty acid levels in red blood cell membranes, relative to their baseline levels, will be measured every three months. The profile of fatty acids will be quantified using gas chromatography coupled with mass spectrometry and expressed as relative percentages of total fatty acids.

    Measured: 3, 6, 9,12 months

  2. Modulation of the Quality of life related to Sleep, changes relative to baseline (time 0) and between arms.

    The Insomnia Severity Scale (ISI, scores 0-28) and the Fatigue Symptom Inventory (FSI, scores 0-10) will be used to evaluate QoL related to sleep. For both questionnaires, higher scores mean a worse outcome.

    Measured: 3, 6, 9, 12 months

  3. Change in Inflammatory mediators levels

    The changes in levels of systemic inflammatory mediators in both arms, relative to their baseline levels, at 3- and 12-month, will be measured. The levels of mediators will be expressed in pg/mL and quantified using validated techniques.

    Measured: 0, 3, 12 months

  4. Modulation of the Quality of life related to Cognitive Function, changes relative to baseline (time 0) and between arms.

    The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) will be used to measure cognitive function. This questionnaire evaluates different subscales, i.e. Perceived Cognitive Impairments (scores 0-72), Impact of Perceived cognitive impairments (scores 0-16), Comments from Others (scores 0-16) and Perceived Cognitive Abilities (scores 0-28). For each subscale, higher scores mean a better outcome.

    Measured: 3, 6, 9,12 months

  5. Modulation of the Quality of life related to Prostate Symptoms, changes relative to baseline (time 0) and between arms.

    The International Prostate Symptom Scale (IPSS) and the Expanded Prostate Cancer Index Composite 26 (EPIC-26) will be used to measure prostate symptoms. The IPSS evaluate urinary symptoms (scores 0-35) and QoL related to these symptoms (scores 0-6). Higher scores mean a worse outcome. The EPIC-26 evaluates prostate symptoms for 5 domains (sexual, urinary incontinence, urinary irritative/obstructive, hormonal and bowel), each score ranging from 0-100. Higher scores mean a better outcome.

    Measured: 0, 3, 6, 9, 12 months

  6. Modulation of the Quality of life related to Anxiety and Depression, changes relative to baseline (time 0) and between arms.

    The Hospital Anxiety and Depression Scale (HADS) will be used to measure anxiety and depression symptoms. Both the anxiety and depression scale scores range from 0-21, where higher scores mean a worse outcome. The Patient Health Questionnaire 9 (PHQ-9, scores 0-27) will be used as well to measure depression symptoms. Higher scores mean more depressive symptoms.

    Measured: 0, 3, 6, 9, 12 months

  7. Modulation of the Quality of life related to Health, changes relative to baseline (time 0) and between arms.

    The 36-Item Short Form Health Survey (SF-36) will be used to measure health-related QoL. Scores range from 0-100 on 8 domains (physical functioning, role physical, general health, pain, social functioning, role emotional, vitality and mental health) and two component summary scales (physical and mental). Higher scores mean better health-related QoL.

    Measured: 0, 3, 6, 9, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2018
  2. Study start10 Jul 2017
  3. Primary completion12 Dec 2023
  4. Study completionDec 2026 (estimated)

Resources

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
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03753334
Sponsor's protocol ID
2017-3407
Acronym
RCT-EPAII-BCR
Status last verified
Dec 2025
First submitted
14 Nov 2018
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MAG-EPA in people with Prostate Cancer, run by CHU de Quebec-Universite Laval at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prostate-specific antigen (PSA) doubling time from baseline to 12 months. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03753334.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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