or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Male
Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage II Prostate Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Post-treatment green tea catechin concentration levels in prostate tissue

Outcome Description:

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.

Outcome Time Frame:

Up to 6 weeks

Safety Issue:

No

Principal Investigator

Frederick Ahmann

Investigator Role:

Principal Investigator

Investigator Affiliation:

Arizona Cancer Center - Tucson

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00894

NCT ID:

NCT00459407

Start Date:

March 2007

Completion Date:

Related Keywords:

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

Name

Location
Arizona Cancer Center - Tucson Tucson, Arizona  85724-5024