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Completed Phase 2 Interventional Results available

Study of Polyphenon E in Men With High-grade Prostatic Intraepithelial Neoplasia

ClinicalTrials.gov ID: NCT00596011

Public ClinicalTrials.gov record NCT00596011. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 6:00 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase II, Randomized, Double-blind, Multi-centered Study of Polyphenon E in Men With High-grade Prostatic Intraepithelial Neoplasia (HGPIN) or Atypical Small Acinar Proliferation (ASAP)

Study identification

NCT ID
NCT00596011
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Other
Enrollment
97 participants

Conditions and interventions

Interventions

  • Polyphenon E Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
30 Years to 80 Years
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 13, 2007
Primary completion
Mar 24, 2014
Completion
Jul 26, 2018
Last update posted
Oct 3, 2019

2007 – 2018

United States locations

U.S. sites
10
U.S. states
5
U.S. cities
8
Facility City State ZIP Site status
University of Florida/Shands-Department of Urology Gainesville Florida 32610
University of Florida - Jacksonville Jacksonville Florida 32209
Watson Clinic Center for Research, Inc. Lakeland Florida 33805
H Lee Moffitt Cancer Center Tampa Florida 33612
James A Haley VA Tampa Florida 33612
University of Chicago - Department of Surgery Chicago Illinois 60637
Overton Brooks VA Medical Center Shreveport Louisiana 71101-4295
LSU Health Sciences Center, Feist-Weiller Cancer Center Shreveport Louisiana 71130
Minneapolis VA Medical Center Minneapolis Minnesota 55417
Jefferson Medical College - Department of Urology Philadelphia Pennsylvania 19107

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00596011, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 3, 2019 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00596011 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →