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

NCT03753334 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 2017-3407
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer

Keywords

Biochemical recurrence (BCR); Androgen-deprivation therapy (ADT); PSA doubling time; Quality of life; Omega-3 fatty acids; Biomarkers; Prostate cancer progression; PSA kinetics

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (7)

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

  3, 6, 9,12 months

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

  3, 6, 9, 12 months

• Change in Inflammatory mediators levels

  0, 3, 12 months

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

  3, 6, 9,12 months

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

  0, 3, 6, 9, 12 months

Study Arms (2)

MAG-EPA group

EXPERIMENTAL

5g/day of omega-3-rich fish oil capsules, which include 4g of purified EPA, to be taken once a day, for 12 months.

Combination Product: MAG-EPA

Placebo group

PLACEBO COMPARATOR

5g/day of high-oleic sunflower oil capsules, to be taken once a day, for 12 months.

Dietary Supplement: Placebo group

Interventions

MAG-EPA COMBINATION_PRODUCT

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

MAG-EPA group

Placebo group DIETARY_SUPPLEMENT

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

Also known as: High oleic sunflower oil

Placebo group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

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

Québec, Quebec, G1R 3S1, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

1-eicosapentaenoylglycerol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Vincent Fradet, MD, PhD

  CHU de Québec-Univeristé Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 27, 2018
• Study Start: July 10, 2017
• Primary Completion: December 12, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

CA (1)