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Phase 2
30 Years
Not Enrolling
Prostatic Intraepithelial Neoplasia

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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



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