Adenocarcinoma of the Prostate Clinical Trial
Official title:
Phase Ib Study of Polyphenon E in a Pre-prostatectomy Prostate Cancer Cohort
Green tea extract contains ingredients that may prevent or slow the growth of prostate cancer. This phase I trial is studying how well green tea extract works in treating patients with prostate cancer undergoing surgery to remove the prostate
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.
;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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