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

Adenocarcinoma of the Prostate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00459407
• Other study ID #: NCI-2009-00894
• Secondary ID: HSC # 06-0695-04
• Status: Completed
• Phase: Phase 1
• First received: April 9, 2007
• Last updated: October 7, 2014
• Start date: March 2007
• Est. completion date: August 2010

Study information

• Verified date: February 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• defined green tea catechin extract
Given orally

Drug:
• placebo
Given orally

Other:
• immunohistochemistry staining method
Correlative studies
• immunoenzyme technique
Correlative studies
• laboratory biomarker analysis
Correlative studies

Procedure:
• biopsy
Undergo biopsy

Other:
• mass spectrometry
Correlative studies
• high performance liquid chromatography
Correlative studies

Locations

Country	Name	City	State
United States	Arizona Cancer Center - Tucson	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Changes in clusterin, matrix metalloproteinase (MMP)-2, and MMP-9 levels	Will be compared between intervention groups using a two-group t-test with a 0.05 two-sided significance level; with a sample size of 23 patients per group, there will be over 90% power to detect a difference equal to an effect size of 1.0. If the distributions are not symmetrical, a non-parametric Wilcoxon test will be considered. Correlations among the various biomarkers, as well as between post-intervention EGCG concentrations and changes in biomarker levels, will be explored (using Pearson or Spearman Rank correlation coefficients as appropriate).	Baseline to post-treatment	No
Secondary	Changes in Serum levels of insulin-like growth factor (IGF)-1 and IGF binding protein-3	Will be compared between intervention groups using a two-group t-test with a 0.05 two-sided significance level; with a sample size of 23 patients per group, there will be over 90% power to detect a difference equal to an effect size of 1.0. If the distributions are not symmetrical, a non-parametric Wilcoxon test will be considered. Correlations among the various biomarkers, as well as between post-intervention EGCG concentrations and changes in biomarker levels, will be explored (using Pearson or Spearman Rank correlation coefficients as appropriate).	Baseline to post-treatment	No
Secondary	Change in ratio of 8OHdG:dG	Statistical analysis will focus on the change scores (defined as changes from baseline to post-intervention). Changes in the Polyphenon E group will be compared with those in the placebo group, using a two-sided t-test.	Baseline to post-treatment	No
Secondary	Change in plasma levels of EGCG	Will be compared between groups, and the correlation of plasma and prostate tissue levels will be examined; however, plasma levels are expected to be low because of the washout during pre-operative fasting. Additional exploratory analyses will investigate the correlation of EGCG tissue levels with adherence during the intervention period (assessed primarily by capsule counts).	Baseline to post-treatment	No