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A Chemoprevention Study of an Investigational Drug in Men With High Grade Prostate Intraepithelial Neoplasia (PIN)

NCT00028353 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2013-11-15

No results posted yet for this study

Summary

If you are a male 30 years of age or older and have a positive diagnosis of high grade (II or III) prostate Intraepithelial Neoplasia (PIN) or have had an abnormal/suspicious prostate biopsy, you may be eligible for this study. This is a study of an investigational medication that may reduce high grade PIN and prevent the occurrence of prostate cancer. This study is currently enrolling up to 500 men at approximately 60 locations in the United States.

Conditions

  • Prostatic Intraepithelial Neoplasia

Interventions

DRUG

GTX-006 (Acapodene)

Sponsors & Collaborators

  • GTx

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-04-30
Completion
2003-07-31

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 NCT00028353 on ClinicalTrials.gov