A Chemoprevention Study of an Investigational Drug in Men With High Grade Prostate Intraepithelial Neoplasia (PIN)
1 other identifier
interventional
500
1 country
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2001
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2001
CompletedFirst Submitted
Initial submission to the registry
December 22, 2001
CompletedFirst Posted
Study publicly available on registry
December 24, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2003
CompletedNovember 15, 2013
November 1, 2013
December 22, 2001
November 13, 2013
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- GTxlead
Study Sites (25)
Private Practice
Huntsville, Alabama, 35801, United States
Arkansas Urology Associates
Little Rock, Arkansas, 72211, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
UroSearch
Leesburg, Florida, 34748, United States
The Urology Center of Florida Inc.
Ocala, Florida, 34474, United States
UroSearch
Ocala, Florida, 34474, United States
Dr. Byron Hodge
Orlando, Florida, 32806, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612-9497, United States
Sandy Springs Urology, P.C.
Atlanta, Georgia, 30328, United States
North Idaho Urology
Couer D'Alene, Idaho, 83814, United States
Wishard Memorial Hospital
Indianapolis, Indiana, 46202, United States
Mid Atlantic Clinical Research
Rockville, Maryland, 20850, United States
Newton Wellesley Urology
Newton, Massachusetts, 02162, United States
Private Practice
Las Vegas, Nevada, 89109, United States
Medical & Clinical Research Associates
Bay Shore, New York, 11706, United States
Clinical Research of Westchester
New Rochelle, New York, 10801, United States
Columbia University
New York, New York, 10032, United States
Private Practice
Staten Island, New York, 10305, United States
Salem Research Group, Inc.
Winston-Salem, North Carolina, 27103, United States
Tri-State Urologic Services
Cincinnati, Ohio, 45212, United States
Urologic Surgery, P.C
Bala-Cynwyd, Pennsylvania, 19004, United States
Urology Associates of Lancaster
Lancaster, Pennsylvania, 17604, United States
Urology San Antonio Research
San Antonio, Texas, 78229, United States
Seattle Urological Associates
Seattle, Washington, 98104, United States
Madigan Army Medical Center
Tacoma, Washington, 98431, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 22, 2001
First Posted
December 24, 2001
Study Start
April 1, 2001
Study Completion
July 1, 2003
Last Updated
November 15, 2013
Record last verified: 2013-11