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

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

MAG-EPA

Placebo group

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Biochemical recurrence (BCR), Androgen-deprivation therapy (ADT), PSA doubling time, Quality of life, Omega-3 fatty acids, Biomarkers, Prostate cancer progression, PSA kinetics

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MAG-EPA group

Placebo group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03753334

First Posted

November 14, 2018

Last Updated

September 20, 2023

Sponsor

CHU de Quebec-Universite Laval

1. Study Identification

Unique Protocol Identification Number

NCT03753334

Brief Title

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

Acronym

RCT-EPAII-BCR

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 10, 2017 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CHU de Quebec-Universite Laval

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MAG-EPA group

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Combination Product

Intervention Name(s)

MAG-EPA

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo group

Other Intervention Name(s)

High oleic sunflower oil

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

3, 6, 9,12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vincent Fradet, MD, PhD

Phone

418-525-4444

Ext

15561

vincent.fradet@fmed.ulaval.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Carole Plante, Inf

Phone

418-691-5050

carole.plante@crchudequebec.ulaval.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vincent Fradet, MD, PhD

Organizational Affiliation

CHU de Québec-Univeristé Laval

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Québec

State/Province

Quebec

ZIP/Postal Code

G1R 3S1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vincent Fradet, MD, PhD

Phone

418-525-4444

Ext

15561

vincent.fradet@fmed.ulaval.ca

First Name & Middle Initial & Last Name & Degree

Carole Plante, Inf

Phone

418-691-5050

Carole.Plante@crchudequebec.ulaval.ca

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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