|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
4 March 2013 |
|
Main ID: |
NCT00459407 |
|
Date of registration:
|
09/04/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Defined Green Tea Catechins in Treating Patients With Prostate Cancer Undergoing Surgery to Remove the Prostate
|
|
Scientific title:
|
Phase Ib Study of Polyphenon E in a Pre-prostatectomy Prostate Cancer Cohort |
|
Date of first enrolment:
|
March 2007 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00459407 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Frederick Ahmann |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Arizona Cancer Center - Tucson |
| | |
|
Key inclusion & 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
|
Adenocarcinoma of the Prostate
|
|
Stage I Prostate Cancer
|
|
Stage II Prostate Cancer
|
|
Intervention(s)
|
|
Dietary Supplement: defined green tea catechin extract
|
|
Drug: placebo
|
|
Other: high performance liquid chromatography
|
|
Other: immunoenzyme technique
|
|
Other: immunohistochemistry staining method
|
|
Other: laboratory biomarker analysis
|
|
Other: mass spectrometry
|
|
Procedure: biopsy
|
|
Primary Outcome(s)
|
|
Post-treatment green tea catechin concentration levels in prostate tissue
[Time Frame: Up to 6 weeks]
|
|
Secondary Outcome(s)
|
|
Change in plasma levels of EGCG
[Time Frame: Baseline to post-treatment]
|
|
Change in ratio of 8OHdG:dG
[Time Frame: Baseline to post-treatment]
|
|
Changes in clusterin, matrix metalloproteinase (MMP)-2, and MMP-9 levels
[Time Frame: Baseline to post-treatment]
|
|
Changes in Serum levels of insulin-like growth factor (IGF)-1 and IGF binding protein-3
[Time Frame: Baseline to post-treatment]
|
|
Secondary ID(s)
|
|
CDR0000538554
|
|
HSC # 06-0695-04
|
|
N01CN35158
|
|
NCI-2009-00894
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|