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

Primary Purpose

Prostatic Intraepithelial Neoplasia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GTX-006 (Acapodene)
Sponsored by
GTx
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostatic Intraepithelial Neoplasia focused on measuring PIN, High Grade Prostate Intraepithelial Neoplasia (PIN)

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Must have confirmed high grade PIN on prostate biopsy within past 6 months. Must have a serum PSA <12 ng/ml. Can not have prostate cancer. Have significant ocular opacities. Can not take finasteride or other testosterone like supplement.

Sites / Locations

  • Private Practice
  • Arkansas Urology Associates
  • South Florida Medical Research
  • UroSearch
  • The Urology Center of Florida Inc.
  • UroSearch
  • Dr. Byron Hodge
  • H. Lee Moffitt Cancer Center
  • Sandy Springs Urology, P.C.
  • North Idaho Urology
  • Wishard Memorial Hospital
  • Mid Atlantic Clinical Research
  • Newton Wellesley Urology
  • Private Practice
  • Medical & Clinical Research Associates
  • Clinical Research of Westchester
  • Columbia University
  • Private Practice
  • Salem Research Group, Inc.
  • Tri-State Urologic Services
  • Urologic Surgery, P.C
  • Urology Associates of Lancaster
  • Urology San Antonio Research
  • Seattle Urological Associates
  • Madigan Army Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 22, 2001
Last Updated
November 13, 2013
Sponsor
GTx
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1. Study Identification

Unique Protocol Identification Number
NCT00028353
Brief Title
A Chemoprevention Study of an Investigational Drug in Men With High Grade Prostate Intraepithelial Neoplasia (PIN)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GTx

4. Oversight

5. Study Description

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.
Detailed Description
High grade PIN is the development of precancerous, abnormal tissue of the prostate gland that puts men at high risk of developing prostate cancer. This study will take one year of participation with clinic visits every three months. There will be two prostate biopsies during the study, at six and twelve months. If qualified to participate, you will be randomly assigned to one of four treatment groups. Three out of four groups are varying doses of the study medication and the other is the placebo group (like a sugar pill).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Intraepithelial Neoplasia
Keywords
PIN, High Grade Prostate Intraepithelial Neoplasia (PIN)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
500 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GTX-006 (Acapodene)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Must have confirmed high grade PIN on prostate biopsy within past 6 months. Must have a serum PSA <12 ng/ml. Can not have prostate cancer. Have significant ocular opacities. Can not take finasteride or other testosterone like supplement.
Facility Information:
Facility Name
Private Practice
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Arkansas Urology Associates
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
UroSearch
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
The Urology Center of Florida Inc.
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
UroSearch
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Dr. Byron Hodge
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Sandy Springs Urology, P.C.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
North Idaho Urology
City
Couer D'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Wishard Memorial Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Mid Atlantic Clinical Research
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Newton Wellesley Urology
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02162
Country
United States
Facility Name
Private Practice
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Medical & Clinical Research Associates
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
Facility Name
Clinical Research of Westchester
City
New Rochelle
State/Province
New York
ZIP/Postal Code
10801
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Private Practice
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Salem Research Group, Inc.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Tri-State Urologic Services
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Urologic Surgery, P.C
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Urology Associates of Lancaster
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Urology San Antonio Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Seattle Urological Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.gtxinc.com
Description
Related Info

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

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