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
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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 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:
|
Adenocarcinoma Adenocarcinoma, Mucinous Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
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 May 19, 2013