Defined Green Tea Catechins in Treating Patients With Prostate Cancer Undergoing Surgery to Remove the Prostate

NCT00459407 | Completed Phase 1

• 4 other identifiers: NCI-2009-00894HSC # 06-0695-04N01CN35158CDR0000538554
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Adenocarcinoma of the Prostate; Stage I Prostate Cancer; Stage II Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Post-treatment green tea catechin concentration levels in prostate tissue

  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.

  Up to 6 weeks

Secondary Outcomes (4)

• Changes in clusterin, matrix metalloproteinase (MMP)-2, and MMP-9 levels

  Baseline to post-treatment

• Changes in Serum levels of insulin-like growth factor (IGF)-1 and IGF binding protein-3

  Baseline to post-treatment

• Change in ratio of 8OHdG:dG

  Baseline to post-treatment

• Change in plasma levels of EGCG

  Baseline to post-treatment

Study Arms (2)

Arm I (green tea catechin extract)

EXPERIMENTAL

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; Other: immunohistochemistry staining method; Other: immunoenzyme technique; Other: laboratory biomarker analysis; Procedure: biopsy; Other: mass spectrometry; Other: high performance liquid chromatography

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive oral placebo daily for 4-7 weeks. All patients undergo surgery one day after the last dose of study agent.

Drug: placebo; Other: immunohistochemistry staining method; Other: immunoenzyme technique; Other: laboratory biomarker analysis; Procedure: biopsy; Other: mass spectrometry; Other: high performance liquid chromatography

Interventions

defined green tea catechin extract DIETARY_SUPPLEMENT

Given orally

Also known as: Polyphenon E

Arm I (green tea catechin extract)

placebo DRUG

Given orally

Also known as: PLCB

Arm II (placebo)

immunohistochemistry staining method OTHER

Correlative studies

Also known as: immunohistochemistry

Arm I (green tea catechin extract); Arm II (placebo)

immunoenzyme technique OTHER

Correlative studies

Also known as: immunoenzyme techniques

Arm I (green tea catechin extract); Arm II (placebo)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (green tea catechin extract); Arm II (placebo)

biopsy PROCEDURE

Undergo biopsy

Also known as: biopsies

Arm I (green tea catechin extract); Arm II (placebo)

mass spectrometry OTHER

Correlative studies

Arm I (green tea catechin extract); Arm II (placebo)

high performance liquid chromatography OTHER

Correlative studies

Also known as: HPLC

Arm I (green tea catechin extract); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Arizona Cancer Center - Tucson

Tucson, Arizona, 85724-5024, United States

Location

Related Publications (1)

• 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.

  PMID: 22044694 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

polyphenon E; Immunohistochemistry; Immunoenzyme Techniques; Biopsy; Mass Spectrometry; Chromatography, High Pressure Liquid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Immunoassay; Molecular Probe Techniques; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Chemistry Techniques, Analytical; Chromatography, Liquid; Chromatography

Study Officials

• Frederick Ahmann

  Arizona Cancer Center - Tucson

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2007
• First Posted: April 11, 2007
• Study Start: March 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 8, 2014

Record last verified: 2013-02

Locations

US (1)