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Sponsors and Collaborators: |
University of Arizona National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00459407 |
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 |
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Prostate Cancer |
Dietary Supplement: defined green tea catechin extract Other: placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | Phase Ib Study of Polyphenon E in a Pre-Prostatectomy Prostate Cancer Cohort |
Estimated Enrollment: | 50 |
Study Start Date: | January 2006 |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral defined green tea catechin extract daily for 4-7 weeks.
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Dietary Supplement: defined green tea catechin extract
Given orally
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Arm II: Placebo Comparator
Patients receive oral placebo daily for 4-7 weeks.
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Other: placebo
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Biopsy-proven adenocarcinoma of the prostate meeting the following criteria:
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Arizona | |
Arizona Cancer Center at University of Arizona Health Sciences Center | Recruiting |
Tucson, Arizona, United States, 85724-5024 | |
Contact: Clinical Trials Office - Arizona Cancer Center at University o 520-626-9008 | |
United States, Maryland | |
NIH - Warren Grant Magnuson Clinical Center | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - NIH - Warren Grant Magnuson Clinical 800-411-1222 |
Study Chair: | Frederick R. Ahmann, MD | University of Arizona |
Study ID Numbers: | CDR0000538554, UARIZ-UAZ05-6-01, UARIZ-HSC-06-0695-04 |
Study First Received: | April 9, 2007 |
Last Updated: | March 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00459407 History of Changes |
Health Authority: | Unspecified |
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer |
Anticarcinogenic Agents Epigallocatechin gallate Antioxidants Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Adenocarcinoma Neuroprotective Agents Prostatic Neoplasms |
Anticarcinogenic Agents Epigallocatechin gallate Antioxidants Genital Neoplasms, Male Prostatic Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Antimutagenic Agents Urogenital Neoplasms |
Genital Diseases, Male Neuroprotective Agents Protective Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Central Nervous System Agents Prostatic Neoplasms |