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Phase 2
30 Years
N/A
Not Enrolling
Male
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:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

211

NCT ID:

NCT00028353

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

Name

Location

Madigan Army Medical CenterTacoma, Washington  98431-5048
Mid Atlantic Clinical ResearchRockville, Maryland  20850
Urology San Antonio ResearchSan Antonio, Texas  78229
Seattle Urological AssociatesSeattle, Washington  98104-1360
Columbia UniversityNew York, New York  10032-3784
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Private PracticeHuntsville, Alabama  35801
Arkansas Urology AssociatesLittle Rock, Arkansas  72211
South Florida Medical ResearchAventura, Florida  33180
UroSearchLeesburg, Florida  34748
The Urology Center of Florida Inc.Ocala, Florida  34474
Dr. Byron HodgeOrlando, Florida  32806
Sandy Springs Urology, P.C.Atlanta, Georgia  30328
North Idaho UrologyCouer D'Alene, Idaho  83814
Wishard Memorial HospitalIndianapolis, Indiana  46202
Newton Wellesley UrologyNewton, Massachusetts  02162
Private PracticeLas Vegas, Nevada  89109
Medical & Clinical Research AssociatesBay Shore, New York  11706
Clinical Research of WestchesterNew Rochelle, New York  10801
Private PracticeStaten Island, New York  10305
Salem Research Group, Inc.Winston Salem, North Carolina  27103
Tri-State Urologic ServicesCincinnati, Ohio  45212
Urologic Surgery, P.CBala Cynwyd, Pennsylvania  19004
Urology Associates of LancasterLancaster, Pennsylvania  17604