Phase Ib Study of Polyphenon E in a Pre-prostatectomy Prostate Cancer Cohort
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.
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
Post-treatment green tea catechin concentration levels in prostate tissue
Descriptive statistics will be performed on prostate tissue EGCG within each intervention group. The difference in concentration levels between the two intervention groups will be tested using a two-group t-test at a one-sided 0.05 level of significance. If the distributions are not symmetrical, a non-parametric Wilcoxon test will be considered. The percentage of patients positive for EGCG in prostate tissue will be compared between the intervention groups using a Fisher's exact test of proportions at a one-sided 0.05 level of significance.
Up to 6 weeks
Arizona Cancer Center - Tucson
United States: Food and Drug Administration
|Arizona Cancer Center - Tucson||Tucson, Arizona 85724-5024|