Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients 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.

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