PRIMARY OBJECTIVES:
I. Determine the bioavailability of defined green tea catechin extract in prostate tissue after treatment with defined green tea extract in patients with prostate cancer.
SECONDARY OBJECTIVES:
I. Determine the effect of this treatment on changes in clusterin levels and matrix metalloproteinase (MMP)-2 and MMP-9 in prostate tissue from these patients.
II. Determine the effect of this treatment on changes in serum insulin-like growth factor (IGF)-1 and IGF binding protein-3 in these patients.
III. Determine the effect of this treatment on changes in oxidative DNA damage in peripheral blood leukocytes in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive oral defined green tea catechin extract daily for 4-7 weeks.
Arm II: Patients receive oral placebo daily for 4-7 weeks.
All patients undergo surgery one day after the last dose of study agent.
Biopsies are taken at the time of surgery. Plasma and tissue catechin levels are measured with high performance liquid chromatography (HPLC). 8OHdG levels in peripheral blood are measured with HPLC and mass spectometry. Immunohistochemistry is used to measure matrix metalloproteinase (MMP)-2, MMP-9, and clusterin. Insulin-like growth factor (IGF)-1 and IGF binding protein-3 are measured with immunoenzyme techniques.
