Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients Who Are at Risk for Developing Prostate Cancer

OHSU Knight Cancer Institute89 enrolled

Overview

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of fish oil and/or green tea may prevent prostate cancer. PURPOSE: This randomized clinical trial is studying how well a fish oil and/or green tea supplement works in preventing prostate cancer in patients with prostatic intraepithelial neoplasia or who are at risk for developing prostate cancer.

OBJECTIVES: * Determine the cancer preventing effects of fish oil supplementation and green tea extract use on markers of alteration in lipid metabolism in prostate tissue samples. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to age (under 65 vs 65 and over). Patients are randomized to 1 of 4 treatment arms. * Arm I: Patients receive oral fish oil three times daily and oral green tea extract twice daily. * Arm II: Patients receive an oil placebo three times daily and oral green tea extract twice daily. * Arm III: Patients receive oral fish oil three times daily and a placebo twice daily. * Arm IV: Patients receive an oil placebo three times daily and another placebo twice daily. Treatment in one of the above-listed arms continues for up to 20 weeks in the absence of disease progression or unacceptable toxicity. All patients undergo a prostate biopsy on the last day of study treatment. After completion of study treatment, patients receive a follow-up phone call at/around 30 days later. PROJECTED ACCRUAL: A total of 144 patients will be accrued for this study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Precancerous Condition Prostate Cancer

Interventions

green tea catechin extractDIETARY_SUPPLEMENT

Given orally 2 times/day

fish oilDIETARY_SUPPLEMENT

Given orally 3 times/day

placeboOTHER

Given olive oil placebo orally 3 times/day

placebo

Eligibility

Sex: MALEMin age: 21 YearsMax age: 120 YearsHealthy volunteers:

Medical Language ↔ Plain English

INCLUSION CRITERIA: * Clinician recommends repeat biopsy of the prostate ("Repeat" is defined as any recommended biopsy of the prostate subsequent to an earlier biopsy of the prostate) EXCLUSION CRITERIA: * Definitive invasive prostate cancer on initial biopsy * Significant active medical illness that in the opinion of the clinician would preclude protocol treatment. * History of ventricular tachycardia or ventricular fibrillation * Subject reported use of fish oil (greater than 1 gram per day) or green tea supplement within 30 days before Day 1 of study treatment * Subject reported use of fish oil ≤ 1 gram per day and unwilling to discontinue use for the duration of the trial * Use of warfarin or need for therapeutic anticoagulation at time of biopsy or at anytime during the course of the trial. * Subject reported allergy or sensitivity to fish oil, olive oil or green tea * Subject reported history of hemophilia, van Willebrands disease or other bleeding disorder, except when the subject is evaluated by a hematologist who determines that fish oil supplementation is not contraindicated. * Total bilirubin greater than institutional upper limit of normal * Concurrent high risk study participation

Locations (3)

Kaiser Permanente Center for Health Research

Portland, Oregon, United States

OHSU Knight Cancer Institute

Portland, Oregon, United States

Veterans Affairs Medical Center - Portland

Portland, Oregon, United States

Outcomes

Primary Outcomes

Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score)

Sections of paraffin-embedded prostate biopsy tissue were stained for fatty acid synthase (FAS) expression. The FAS Summary Score was calculated as the product of percent stained (1=0-25%, 2=25-50%, 3=51-75%, 4=76-100%) and stain intensity (0-3) by immunohistochemistry. The range of the product is 0-300.

Time frame: Baseline (pre-intervention) and end of study (time to surgery for those with malignant findings or up to 8 weeks for those with benign biopsies, post-intervention)

Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention

Cell Proliferation by Ki67 is calculated as the percent stained by immunohistochemistry. Ki-67 values were log-transformed because the original distribution was skewed. Analysis was done on log-base2 transformed values.

Time frame: End of study

Data from ClinicalTrials.gov

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