Clinical trial NCT00459407: Defined Green Tea Catechins in Treating Patients With Prostate Cancer Undergoing Surgery to Remove the Prostate
Official title: Phase Ib Study of Polyphenon E in a Pre-prostatectomy Prostate Cancer Cohort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adenocarcinoma of the Prostate
Stage I Prostate Cancer
Stage II Prostate Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-04-11
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

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 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

Primary outcomes:
measure: Post-treatment green tea catechin concentration levels in prostate tissue
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Changes in clusterin, matrix metalloproteinase (MMP)-2, and MMP-9 levels
timeFrame: Baseline to post-treatment
measure: Changes in Serum levels of insulin-like growth factor (IGF)-1 and IGF binding protein-3
timeFrame: Baseline to post-treatment
measure: Change in ratio of 8OHdG:dG
timeFrame: Baseline to post-treatment
measure: Change in plasma levels of EGCG
timeFrame: Baseline to post-treatment
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center - Tucson
state: Arizona
Study officials:
affiliation: Arizona Cancer Center - Tucson
name: Frederick Ahmann
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen MM, Ahmann FR, Nagle RB, Hsu CH, Tangrea JA, Parnes HL, Sokoloff MH, Gretzer MB, Chow HH. Randomized, double-blind, placebo-controlled trial of polyphenon E in prostate cancer patients before prostatectomy: evaluation of potential chemopreventive activities. Cancer Prev Res (Phila). 2012 Feb;5(2):290-8. doi: 10.1158/1940-6207.CAPR-11-0306. Epub 2011 Nov 1.