Clinical trial NCT00028353: A Chemoprevention Study of an Investigational Drug in Men With High Grade Prostate Intraepithelial Neoplasia (PIN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Intraepithelial Neoplasia
Keywords: PIN
High Grade Prostate Intraepithelial Neoplasia (PIN)
Lead sponsor: GTx
Sponsor class: INDUSTRY
First posted: 2001-12-24
Enrollment: 500
Sex: MALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Private Practice
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Urology Associates
state: Arkansas
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Leesburg
country: United States
facility: UroSearch
state: Florida
city: Ocala
country: United States
facility: The Urology Center of Florida Inc.
state: Florida
city: Ocala
country: United States
facility: UroSearch
state: Florida
city: Orlando
country: United States
facility: Dr. Byron Hodge
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Sandy Springs Urology, P.C.
state: Georgia
city: Couer D'Alene
country: United States
facility: North Idaho Urology
state: Idaho
city: Indianapolis
country: United States
facility: Wishard Memorial Hospital
state: Indiana
city: Rockville
country: United States
facility: Mid Atlantic Clinical Research
state: Maryland
city: Newton
country: United States
facility: Newton Wellesley Urology
state: Massachusetts
city: Las Vegas
country: United States
facility: Private Practice
state: Nevada
city: Bay Shore
country: United States
facility: Medical & Clinical Research Associates
state: New York
city: New Rochelle
country: United States
facility: Clinical Research of Westchester
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Staten Island
country: United States
facility: Private Practice
state: New York
city: Winston-Salem
country: United States
facility: Salem Research Group, Inc.
state: North Carolina
city: Cincinnati
country: United States
facility: Tri-State Urologic Services
state: Ohio
city: Bala Cynwyd
country: United States
facility: Urologic Surgery, P.C
state: Pennsylvania
city: Lancaster
country: United States
facility: Urology Associates of Lancaster
state: Pennsylvania
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: Seattle
country: United States
facility: Seattle Urological Associates
state: Washington
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
References: