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:||June 2016|
|Estimated Primary Completion Date:||June 2016 (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296672
|Contact: Joseph Long||(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: Joseph Long 210-450-0754 email@example.com|
|Principal Investigator: Javier Hernandez, MD|
|Principal Investigator:||Javier Hernandez, MD||The University of Texas Health Science Center at San Antonio|