Defined Green Tea Catechins in Treating Patients With Prostate Cancer Undergoing Surgery to Remove the Prostate - Full Text View

Sponsor:	National Cancer Institute (NCI)
Collaborator:	University of Arizona
Information provided by (Responsible Party):	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00459407

Purpose

RATIONALE: Green tea extract contains ingredients that may prevent or slow the growth of prostate cancer.

PURPOSE: 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
Prostate Cancer	Dietary Supplement: defined green tea catechin extract Other: placebo	Phase I

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Catechin Epigallocatechin gallate

U.S. FDA Resources

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

Primary Outcome Measures:

Post-treatment green tea catechin concentration levels in prostate tissue [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clusterin, matrix metalloproteinase (MMP)-2, and MMP-9 levels [ Designated as safety issue: No ]
Serum levels of insulin-like growth factor (IGF)-1 and IGF binding protein-3 [ Designated as safety issue: No ]
Ratio of 8OHdG:dG [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	January 2006
Study Completion Date:	May 2011
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Patients receive oral defined green tea catechin extract daily for 4-7 weeks.	Dietary Supplement: defined green tea catechin extract Given orally
Placebo Comparator: Arm II Patients receive oral placebo daily for 4-7 weeks.	Other: placebo Given orally

Detailed Description:

OBJECTIVES:

Primary

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

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.
Determine the effect of this treatment on changes in serum insulin-like growth factor (IGF)-1 and IGF binding protein-3 in these patients.
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.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Biopsy-proven adenocarcinoma of the prostate meeting the following criteria:
- Organ-confined disease
- Treatable by prostatectomy
PSA < 50 ng/mL

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

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

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

Locations

United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
United States, Maryland
NIH - Warren Grant Magnuson Clinical Center
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

University of Arizona

Investigators

Study Chair:

Frederick R. Ahmann, MD

University of Arizona

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00459407 History of Changes
Other Study ID Numbers:	CDR0000538554, P30CA023074, UARIZ-UAZ05-6-01, UARIZ-HSC-06-0695-04
Study First Received:	April 9, 2007
Last Updated:	October 3, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
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 February 09, 2012