Trial record 1 of 1 for:      Phase Ib Study of Polyphenon E in a Pre-prostatectomy Cohort
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Defined Green Tea Catechins in Treating Patients With Prostate Cancer Undergoing Surgery to Remove the Prostate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00459407
First received: April 9, 2007
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Adenocarcinoma of the Prostate
Stage I Prostate Cancer
Stage II Prostate Cancer
Dietary Supplement: defined green tea catechin extract
Drug: placebo
Other: immunohistochemistry staining method
Other: immunoenzyme technique
Other: laboratory biomarker analysis
Procedure: biopsy
Other: mass spectrometry
Other: high performance liquid chromatography
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Phase Ib Study of Polyphenon E in a Pre-prostatectomy Prostate Cancer Cohort

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Post-treatment green tea catechin concentration levels in prostate tissue [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Changes in clusterin, matrix metalloproteinase (MMP)-2, and MMP-9 levels [ Time Frame: Baseline to post-treatment ] [ Designated as safety issue: No ]
    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).

  • Changes in Serum levels of insulin-like growth factor (IGF)-1 and IGF binding protein-3 [ Time Frame: Baseline to post-treatment ] [ Designated as safety issue: No ]
    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).

  • Change in ratio of 8OHdG:dG [ Time Frame: Baseline to post-treatment ] [ Designated as safety issue: No ]
    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.

  • Change in plasma levels of EGCG [ Time Frame: Baseline to post-treatment ] [ Designated as safety issue: No ]
    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).


Enrollment: 50
Study Start Date: March 2007
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (green tea catechin extract)

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.

Dietary Supplement: defined green tea catechin extract
Given orally
Other Name: Polyphenon E
Other: immunohistochemistry staining method
Correlative studies
Other Name: immunohistochemistry
Other: immunoenzyme technique
Correlative studies
Other Name: immunoenzyme techniques
Other: laboratory biomarker analysis
Correlative studies
Procedure: biopsy
Undergo biopsy
Other Name: biopsies
Other: mass spectrometry
Correlative studies
Other: high performance liquid chromatography
Correlative studies
Other Name: HPLC
Placebo Comparator: Arm II (placebo)

Patients receive oral placebo daily for 4-7 weeks.

All patients undergo surgery one day after the last dose of study agent.

Drug: placebo
Given orally
Other Name: PLCB
Other: immunohistochemistry staining method
Correlative studies
Other Name: immunohistochemistry
Other: immunoenzyme technique
Correlative studies
Other Name: immunoenzyme techniques
Other: laboratory biomarker analysis
Correlative studies
Procedure: biopsy
Undergo biopsy
Other Name: biopsies
Other: mass spectrometry
Correlative studies
Other: high performance liquid chromatography
Correlative studies
Other Name: HPLC

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459407

Locations
United States, Arizona
Arizona Cancer Center - Tucson
Tucson, Arizona, United States, 85724-5024
Sponsors and Collaborators
Investigators
Principal Investigator: Frederick Ahmann Arizona Cancer Center - Tucson
  More Information

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00459407     History of Changes
Other Study ID Numbers: NCI-2009-00894, HSC # 06-0695-04, N01CN35158, CDR0000538554
Study First Received: April 9, 2007
Last Updated: February 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014