Low-Fat Diet and Fish Oil in Men on Active Surveillance for Prostate Cancer

Adenocarcinoma of the Prostate Clinical Trial

Official title:

A Phase II Randomized, Open-Label, Two-Arm Study of a Low Omega-6, High Omega-3 Fat Diet Combined With Fish Oil vs. a Control Group in Men on Active Surveillance for Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02176902
• Other study ID #: 13-000432
• Secondary ID: NCI-2014-0125713
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2014
• Est. completion date: November 1, 2025

Study information

• Verified date: July 2023
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized phase II trial will evaluate if a low omega-6, high omega-3 fat diet combined with fish oil has the potential to delay disease progression in patients with prostate cancer undergoing active surveillance.

Description:

PRIMARY OBJECTIVES:

I. Determine if a 1-year low omega-6, high omega-3 fat diet combined with fish oil results in decreased prostate cancer Ki-67 index as compared to a control group in men on active surveillance.

SECONDARY OBJECTIVES:

I. Evaluate the effect of a low-fat (LF)/fish oil (FO) intervention on prostate biopsy tissue markers of progression, prostate biopsy pathologic features (Gleason grade, tumor volume ), prostate-specific antigen (PSA), and long-term clinical outcomes (clinical progression, prostate cancer therapies).

II. Evaluate potential surrogate biomarkers of proliferation (red blood cell [RBC] membrane fatty acid analyses, ex-vivo bioassay).

III. Determine if a correlation exists between free fatty acid receptor 4 (GPR120) levels and progression markers in response to the LF/FO intervention.

IV. Evaluate effect of the intervention on the National Comprehension Cancer Network (NCCN) risk group V. Evaluate compliance with a 1-year + 2 year extension LF/FO intervention. VI. Evaluate safety of a 1-year + 2-year extension LF/FO intervention.

OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive no intervention.

ARM II: Patients receive dietary counseling with a research dietitian weekly for 1 month and then monthly for 11 months. Patients are given guidelines with recommended meals to follow a high omega-3, low omega-6 diet comprising 30% kilocalories (Kcal) from fat, 15% Kcal from protein, and 65% Kcal from carbohydrates for 1 year. Patients also receive 4 fish oil capsules per day orally (PO) for 1 year.

After completion of study, patients are followed up yearly for 15 years.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 107
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients sign the informed consent

• Patient had a prostate biopsy performed by Dr. Mark with the Artemis device and has adenocarcinoma of the prostate

• Patient elects to undergo active surveillance

• Clinical stage T2c or less

• Gleason grade 3+4 or less

• PSA < 25

• Geographically able to have study visits at the University of California, Los Angeles (UCLA) Clinical Research Unit

• Subjects are willing to not consume lycopene, green tea or pomegranate supplements or pomegranate juice during the 1-year study

• If subjects are randomized to the control group they agree to not consume fish oil capsules during the 1-year study

Exclusion Criteria:

• Diagnostic prostate biopsy with only 1 core with cancer and < 5% of tissue from that core involved with cancer

• Patient has taken finasteride or dutasteride during the prior year

• Patient has taken fish oil during the prior 3 months

• Patient had prior treatment for prostate cancer (surgery, radiation, local ablative therapy, anti-androgen therapy or androgen deprivation therapy)

• Patient has other medical conditions that exclude him from undergoing a repeat prostate biopsy at 1-year

• Patient has allergy to fish

Related Conditions & MeSH terms

• Adenocarcinoma of the Prostate
• Prostatic Neoplasms
• Stage I Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer

Intervention

Behavioral:
• behavioral dietary intervention
Receive dietary counseling
• behavioral dietary intervention
Receive guidelines for low-fat diet

Dietary Supplement:
• omega-3 fatty acid
Given PO

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (4)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI), Pharmavite LLC, Seafood Industry Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ki-67 index	The primary statistical analysis will be to compare the Ki67 index between the two intervention arms using a negative binomial mixed effects model	1 year
Secondary	Composite measure: Prostate biopsy tissue markers of proliferation, cell cycle progression, and prostate biopsy pathologic features (Gleason grade, percent of cores with cancer, and percent of tissue with cancer)	Different types of regression models will be used to assess the influence of the intervention and clinical characteristics (ex. logistic regression, ordinal regression, Poisson regression instead of linear regression).	1 year
Secondary	Serum PSA	Different types of regression models will be used to assess the influence of the intervention and clinical characteristics (ex. logistic regression, ordinal regression, Poisson regression instead of linear regression).	Up to 1 year
Secondary	Composite measure: Long-term clinical outcomes (clinical progression, prostate cancer therapies)	Different types of regression models will be used to assess the influence of the intervention and clinical characteristics (ex. logistic regression, ordinal regression, Poisson regression instead of linear regression).	Up to 15 years
Secondary	Composite measure: Potential surrogate biomarkers of proliferation (RBC membrane fatty acid analyses, ex-vivo bioassay)	Different types of regression models will be used to assess the influence of the intervention and clinical characteristics (ex. logistic regression, ordinal regression, Poisson regression instead of linear regression). Whether the omega-6/omega-3 ratio provides additional predictive information beyond group will be assessed by investigating whether it correlates with Ki-67 within each group.	Up to 1 year
Secondary	Correlation of GPR120 expression in peripheral blood mononuclear cells (PBMCs) and prostate biopsy tissue with immunostaining of Ki67 and Decipher Score	Linear regression will be used to correlate PBMC and biopsy GPR120 gene and protein expression to 1-year Ki-67 index and Decipher score . GPR120 gene and protein expression will be added to the linear regression for Ki-67 constructed with group and clinical/demographic covariates.	Up to 1 year
Secondary	Compliance, defined as having taken 80% or more of the daily fish oil throughout the trial determined based on pill count	Analysis of subject compliance to dietary regimen	Up to 1 year
Secondary	Incidence of adverse events graded according to National Cancer Institute Common Toxicity Criteria version 4.0	Measure of adverse events incidence	Up to 1 year
Secondary	Sample storage for future research	Urine, plasma and flash frozen prostate tissue will be stored for future research evaluating the effects of a LF/FO diet on prostate cancer progression.	Up to 1 year