NCT00459407

Defined Green Tea Catechins in Treating Patients With Prostate Cancer Undergoing Surgery to Remove the Prostate

Phase Ib Study of Polyphenon E in a Pre-prostatectomy Prostate Cancer Cohort

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Adenocarcinoma of the Prostate
• Stage I Prostate Cancer
• Stage II Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	defined green tea catechin extract	Given orally
DRUG	placebo	Given orally
OTHER	immunohistochemistry staining method	Correlative studies
OTHER	immunoenzyme technique	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies
PROCEDURE	biopsy	Undergo biopsy
OTHER	mass spectrometry	Correlative studies
OTHER	high performance liquid chromatography	Correlative studies

Timeline

• Start date: 2007-03-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2007-04-11
• Last updated: 2014-10-08

Locations

1 site across 1 country: United States