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Omega 3 Fatty Acid

Sunflower

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

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

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

MAG-EPA

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

Placebo group

Vincent Fradet, MD, PhD

Carole Plante, Inf

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.

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.

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.

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.

CHU de Quebec-Universite Laval

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer.	NCT03753334	Prostate Cancer	MAG-EPA Placebo group	18 Years - 100 Years	CHU de Quebec-Universite Laval
Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer.	NCT03753334	Prostate Cancer	MAG-EPA Placebo group	18 Years - 100 Years	CHU de Quebec-Universite Laval

Spots Global Cancer Trial Database for biochemical recurrence (bcr)