3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer
The investigators will propose a novel method to improve prostate cancer screening with PSA, using a 3-month treatment with finasteride, a drug used to treat Benign Prostatic Hyperplasia (BPH) and proven to reduce a man's risk of developing prostate cancer. The investigators will also examine three additional promising tests that may further improve diagnosis of prostate cancer.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Screening
|Official Title:||Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test|
- 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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]Participants will take Finasteride/Placebo 5mg per day by mouth for 3 months before prostate biopsy.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Finasteride 5mg tablets every day by mouth for 3 months
Finasteride 5mg every day by mouth for 3 months
Placebo Comparator: Placebo
Placebo 5mg tablet every day by mouth for 3 months
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, Incorporated.
|Contact: Carolina Lizcano, BS, LVN||(210) firstname.lastname@example.org|
|United States, Texas|
|The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Carolina Lizcano, BS, LVN 210-450-0705 email@example.com|
|Principal Investigator: Javier Hernandez, MD|
|Principal Investigator:||Javier Hernandez, MD||The University of Texas Health Science Center at San Antonio|