Know Cancer

forgot password

Phase 2
30 Years
Not Enrolling
Prostatic Intraepithelial Neoplasia

Thank you

Trial Information

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).

Inclusion 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


United States: Food and Drug Administration

Study ID:




Start Date:

April 2001

Completion Date:

July 2003

Related Keywords:

  • Prostatic Intraepithelial Neoplasia
  • PIN
  • High Grade Prostate Intraepithelial Neoplasia (PIN)
  • Neoplasms
  • Prostatic Intraepithelial Neoplasia
  • Carcinoma in Situ



Madigan Army Medical Center Tacoma, Washington  98431-5048
Mid Atlantic Clinical Research Rockville, Maryland  20850
Urology San Antonio Research San Antonio, Texas  78229
Seattle Urological Associates Seattle, Washington  98104-1360
Columbia University New York, New York  10032-3784
H. Lee Moffitt Cancer Center Tampa, Florida  33612
Private Practice Huntsville, Alabama  35801
Arkansas Urology Associates Little Rock, Arkansas  72211
South Florida Medical Research Aventura, Florida  33180
UroSearch Leesburg, Florida  34748
The Urology Center of Florida Inc. Ocala, Florida  34474
Dr. Byron Hodge Orlando, Florida  32806
Sandy Springs Urology, P.C. Atlanta, Georgia  30328
North Idaho Urology Couer D'Alene, Idaho  83814
Wishard Memorial Hospital Indianapolis, Indiana  46202
Newton Wellesley Urology Newton, Massachusetts  02162
Private Practice Las Vegas, Nevada  89109
Medical & Clinical Research Associates Bay Shore, New York  11706
Clinical Research of Westchester New Rochelle, New York  10801
Private Practice Staten Island, New York  10305
Salem Research Group, Inc. Winston Salem, North Carolina  27103
Tri-State Urologic Services Cincinnati, Ohio  45212
Urologic Surgery, P.C Bala Cynwyd, Pennsylvania  19004
Urology Associates of Lancaster Lancaster, Pennsylvania  17604