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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Catechins and Omega-3 Fatty Acids Impact on Fatty Acid Synthase Activity in the Prostate: A Randomized Controlled Trial

Conditions
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Precancerous Condition, Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: green tea catechin extract
* Dietary Supplement: fish oil
* Other: placebo
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (FO, GT catechin extract)<br>Patients receive oral fish oil (FO) 3/day and oral green tea (GT) extract 2/day | Dietary Supplement: green tea catechin extract<br>* Given orally 2 times/day<br>* Other names: Polyphenon E;Dietary Supplement: fish oil<br>* Given orally 3 times/day<br>* Other names: omega-3 fatty acid, n-3 fatty acid, omega-3 polyunsaturated fatty acid, omega-3 PUFA;|
| Experimental: ArmII (FO placebo, GT catechin extract)<br>Patients receive a fish oil (FO) placebo 3/day and oral green tea (GT) extract 2/day | Dietary Supplement: green tea catechin extract<br>* Given orally 2 times/day<br>* Other names: Polyphenon E;Other: placebo<br>* Given green tea placebo orally 2 times/day<br>* Other names: PLCB;|
| Experimental: Arm III (FO, GT placebo)<br>Patients receive oral fish oil (FO) 3/day and a placebo mimicking green tea (GT) catechins 2/day | Dietary Supplement: fish oil<br>* Given orally 3 times/day<br>* Other names: omega-3 fatty acid, n-3 fatty acid, omega-3 polyunsaturated fatty acid, omega-3 PUFA;Other: placebo<br>* Given olive oil placebo orally 3 times/day<br>* Other names: PLCB, olive oil;|
| Placebo Comparator: Arm IV (FO placebo, GT placebo)<br>Patients receive a fish oil (FO) placebo mimicking fish oil 3/day and another placebo mimicking green tea (GT) catechins 2/day | Other: placebo<br>* Given olive oil placebo orally 3 times/day<br>* Other names: PLCB, olive oil;Other: placebo<br>* Given green tea placebo orally 2 times/day<br>* Other names: PLCB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | End of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, precancerous condition