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

National Cancer Institute (NCI)

Status and phase

Completed

Phase 1

Conditions

Stage II Prostate Cancer

Adenocarcinoma of the Prostate

Stage I Prostate Cancer

Treatments

Other: immunoenzyme technique

Other: mass spectrometry

Drug: placebo

Dietary Supplement: defined green tea catechin extract

Procedure: biopsy

Other: high performance liquid chromatography

Other: laboratory biomarker analysis

Other: immunohistochemistry staining method

Study type

Interventional

Funder types

NIH

Identifiers

NCT00459407

CDR0000538554 (Registry Identifier)

N01CN35158 (U.S. NIH Grant/Contract)

HSC # 06-0695-04

NCI-2009-00894

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Criteria:

Biopsy-proven adenocarcinoma of the prostate meeting the following criteria: organ-confined disease; treatable by prostatectomy
PSA < 50 ng/mL
ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
Bilirubin normal
AST and ALT normal
Creatinine normal
Fertile patients must use effective contraception
No uncontrolled intercurrent illness including, but not limited to, any of the following: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; psychiatric illness or social situations that would limit study compliance
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to green tea extract
No prior therapy for prostate cancer (i.e., hormone therapy, radiation therapy, or surgery)
No systemic treatment (chemotherapy) and/or radiation therapy for any malignancy within the past 5 years (excluding nonmelanoma skin cancer or cancer confined to organs with surgical removal as the only treatment)
No regular tea consumption (> 6 servings of hot tea or 12 servings of iced tea or equivalent combination per week) within the past month
No other concurrent investigational agents
No other concurrent consumption of tea or tea-derived products from green, black, or oolong tea

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups, including a placebo group

Arm I (green tea catechin extract)

Experimental group

Description:

Patients receive oral defined green tea catechin extract daily for 4-7 weeks. All patients undergo surgery one day after the last dose of study agent.

Treatment: