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Defined Green Tea Catechin Extract in Treating Patients With Localized Prostate Cancer Undergoing Surgery

NCT01340599 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2012-03-15

No results posted yet for this study

Summary

This randomized pilot phase II trial studies the side effects and how well defined green tea catechin extract works in treating patients with localized prostate cancer undergoing surgery. Defined green tea catechin extract contains ingredients that may prevent or slow the growth of certain cancers.

Conditions

  • Stage I Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer

Interventions

DIETARY_SUPPLEMENT

defined green tea catechin extract

Given PO

OTHER

placebo

Given PO

OTHER

immunohistochemistry staining method

Correlative studies

OTHER

immunoenzyme technique

Correlative studies

OTHER

questionnaire administration

Ancillary studies

PROCEDURE

therapeutic conventional surgery

Undergo radical prostatectomy

OTHER

high performance liquid chromatography

Correlative studies

OTHER

mass spectrometry

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Sanjay Gupta · Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2007-04-30
Completion
2007-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01340599 on ClinicalTrials.gov