Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test
The primary goal of this proposal is to determine if a 5-alpha reductase 'challenge'
improves screening performance of PSA and DRE in men who are scheduled for prostate biopsy.
Currently a higher PSA level leads to a recommendation for prostate biopsy, causing hundreds
of thousands of unnecessary biopsies annually in the U.S. We will show that a three-month
treatment with finasteride for men with high PSA levels will better predict the man who
should have a prostate biopsy. PSA performance after finasteride 'challenge' will also be
compared with new tests for prostate cancer. Finasteride is supplied by Merck and Company,
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Screening
Determine if finasteride improves the Prostate Specific Antigen (PSA) and the Digital Rectal Exam (DRE) for prostate cancer screening by reducing the PSA and the size of the prostate.
Participants will take Finasteride/Placebo 5mg per day by mouth for 3 months before prostate biopsy.
Javier Hernandez, MD
The University of Texas Health Science Center at San Antonio
United States: Institutional Review Board
|The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center||San Antonio, Texas 78229|