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

Further Study Details: 

Expected Total Enrollment:  500

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).

Ages Eligible for Study:  30 Years and above,  Genders Eligible for Study:  Male

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.

Alabama
      Private Practice, Huntsville,  Alabama,  35801,  United States
Arkansas
      Arkansas Urology Associates, Little Rock,  Arkansas,  72211,  United States
Florida
      UroSearch, Ocala,  Florida,  34474,  United States
      South Florida Medical Research, Aventura,  Florida,  33180,  United States
      Dr. Byron Hodge, Orlando,  Florida,  32806,  United States
      The Urology Center of Florida Inc., Ocala,  Florida,  34474,  United States
      H. Lee Moffitt Cancer Center, Tampa,  Florida,  33612-9497,  United States
      UroSearch, Leesburg,  Florida,  34748,  United States
Georgia
      Sandy Springs Urology, P.C., Atlanta,  Georgia,  30328,  United States
Idaho
      North Idaho Urology, Couer D'Alene,  Idaho,  83814,  United States
Indiana
      Wishard Memorial Hospital, Indianapolis,  Indiana,  46202,  United States
Maryland
      Mid Atlantic Clinical Research, Rockville,  Maryland,  20850,  United States
Massachusetts
      Newton Wellesley Urology, Newton,  Massachusetts,  02162,  United States
Nevada
      Private Practice, Las Vegas,  Nevada,  89109,  United States
New York
      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
      Medical & Clinical Research Associates, Bay Shore,  New York,  11706,  United States
North Carolina
      Salem Research Group, Inc., Winston Salem,  North Carolina,  27103,  United States
Ohio
      Tri-State Urologic Services, Cincinnati,  Ohio,  45212,  United States
Pennsylvania
      Urologic Surgery, P.C, Bala Cynwyd,  Pennsylvania,  19004,  United States
      Urology Associates of Lancaster, Lancaster,  Pennsylvania,  17604,  United States
Texas
      Urology San Antonio Research, San Antonio,  Texas,  78229,  United States
Washington
      Madigan Army Medical Center, Tacoma,  Washington,  98431,  United States
      Seattle Urological Associates, Seattle,  Washington,  98104,  United States

Study ID Numbers:  211
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  December 22, 2001
ClinicalTrials.gov Identifier:  NCT00028353
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08