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.