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

Purpose

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.

Condition	Intervention	Phase
Prostatic Intraepithelial Neoplasia	Drug: GTX-006 (Acapodene)	Phase II

MedlinePlus related topics:

Cancer

Drug Information available for:

Toremifene Toremifene citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by GTx:

Estimated Enrollment:	500
Study Start Date:	April 2001
Estimated Study Completion Date:	July 2003

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).

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028353

Show 25 Study Locations

Sponsors and Collaborators

GTx

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	211
First Received:	December 22, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00028353
Health Authority:	United States: Food and Drug Administration

Keywords provided by GTx:

High Grade Prostate Intraepithelial Neoplasia (PIN)

Study placed in the following topic categories:

Prostatic Intraepithelial Neoplasia

Carcinoma in Situ

Toremifene

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on December 03, 2008

Sponsored by:	GTx
Information provided by:	GTx
ClinicalTrials.gov Identifier:	NCT00028353