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Omega-3 Fatty Acid

EPA for Prostate Cancer (RCT-EPA Trial)

Phase 2

Waitlist Available

Led By Vincent Fradet, MD, PhD

Research Sponsored by CHU de Quebec-Universite Laval

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 1 year

Awards & highlights

RCT-EPA Trial Summary

This trial will test if fish oil monoglycerides rich in EPA has global positive effects on prostate cancer cell proliferation, inflammation and on the patient's psychosocial functioning and quality of life, in men with high-risk prostate cancer.

Eligible Conditions

Prostate Cancer

RCT-EPA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks, 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Prostate Cancer Proliferative Index

Secondary outcome measures

Change in Inflammatory mediators levels- Systemic

Impact of inflammation on Quality of life

Impact of inflammation on psychosocial functioning

+3 more

Other outcome measures

Change on PSA level (ng/mL), relative to baseline

Fatty acid profiles in prostate tissue

Fatty acid profiles in red blood cell membranes, change relative to baseline

+3 more

RCT-EPA Trial Design

2Treatment groups

Experimental Treatment

Group I: Purified EPA groupExperimental Treatment1 Intervention

3g per day of purified EPA, capsules, to be taken once a day, for 14 months.

Group II: Placebo groupExperimental Treatment1 Intervention

3 g per day of high-oleic sunflower oil capsules, to be taken once a day, for 14 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

EPA

2015

N/A

~1990

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Find a Location

Who is running the clinical trial?

CHU de Quebec-Universite LavalLead Sponsor

167 Previous Clinical Trials

107,027 Total Patients Enrolled

12 Trials studying Prostate Cancer

3,712 Patients Enrolled for Prostate Cancer

Vincent Fradet, MD, PhDPrincipal InvestigatorLaval University and Hotel Dieu-de-Quebec

1 Previous Clinical Trials

40 Total Patients Enrolled

1 Trials studying Prostate Cancer

40 Patients Enrolled for Prostate Cancer

Media Library

EPA (Omega-3 Fatty Acid) Clinical Trial Eligibility Overview. Trial Name: NCT02333435 — Phase 2

Prostate Cancer Research Study Groups: Placebo group, Purified EPA group

Prostate Cancer Clinical Trial 2023: EPA Highlights & Side Effects. Trial Name: NCT02333435 — Phase 2

EPA (Omega-3 Fatty Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02333435 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies left for participants of this clinical trial?

"From what is available on clinicaltrials.gov, this medical trial has ceased its recruitment process; the initial posting was dated January 1st 2015 and the last update occurred in May of 2022. Nonetheless, there are still over 1300 other trials actively looking for volunteers."

Answered by AI

How hazardous is exposure to environmental protection agency (EPA) chemicals for human health?

"Evidence of EPA's safety is present, thus it has been assessed with a score of 2. This Phase 2 trial does not yet contain any data indicating efficacy."

Answered by AI

Recent research and studies

BMC CancerJournal

Effects of Concentrated Long-chain Omega-3 Polyunsaturated Fatty Acid Supplementation Before Radical Prostatectomy on Prostate Cancer Proliferation, Inflammation, and Quality of Life: Study Protocol for a Phase Iib, Randomized, Double-blind, Placebo-controlled Trial

Guertin, Marie-Hélène, Karine Robitaille, Jean-François Pelletier, Thierry Duchesne, Pierre Julien, Josée Savard, Isabelle Bairati, and Vincent Fradet. 2018. “Effects of Concentrated Long-chain Omega-3 Polyunsaturated Fatty Acid Supplementation Before Radical Prostatectomy on Prostate Cancer Proliferation, Inflammation, and Quality of Life: Study Protocol for a Phase Iib, Randomized, Double-blind, Placebo-controlled Trial”. BMC Cancer. Springer Science and Business Media LLC. doi:10.1186/s12885-017-3979-9.

clinicaltrials.govStudy

Effects of EPA on Prostate Cancer Cells Proliferation and Quality of Life

2015. "Effects of EPA on Prostate Cancer Cells Proliferation and Quality of Life". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02333435.