RCT-EPAII-BCR: Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer.

Sponsor

CHU de Quebec-Universite Laval (Other)

Overall Status

Recruiting

CT.gov ID

NCT03753334

Collaborator

(none)

Enrollment

Location

Arms

76.7

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Combination Product: MAG-EPA Dietary Supplement: Placebo group	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Jul 10, 2017

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MAG-EPA group 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 5g/day of omega-3-rich fish oil including 4g of purified monoglycerides EPA, capsules, taken once daily, for 12 months
Placebo Comparator: Placebo group 5g/day of high-oleic sunflower oil capsules, to be taken once a day, for 12 months.	Dietary Supplement: Placebo group 5g/day of placebo (high oleic sunflower oil), capsules, taken once daily, for 12 months Other Names: High oleic sunflower oil

Arm

Intervention/Treatment

Experimental: MAG-EPA group

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

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

Placebo Comparator: Placebo group

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

Dietary Supplement: Placebo group

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

Other Names:

High oleic sunflower oil

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Fatty acid profiles in red blood cells, changes relative to baseline (time 0). [3, 6, 9,12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.