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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
TRIPLE
Enrollment
383
Finasteride 5mg every day by mouth for 3 months
Placebo every day by mouth for 3 months
The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center
San Antonio, Texas, United States
Pre/Post Ratio PSA Area Under the Curve (AUC)
Pre/Post Ratio prediction area under the receiver operating characteristics curve (AUC) for subjects taking finasteride 5mg every day for 3 months. Measurements of PSA are measured from Baseline until 3 months.
Time frame: Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months
PCA3 (Prostate Cancer Antigen 3)Score AUC
Area under the Receiver Operating Characteristic Curve (ROC-AUC) of the PCA3 (Prostate Cancer Antigen 3) to detect difference in PSA decline between cases and controls (non-cases)
Time frame: Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day
T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC
Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score to Predict the Risk of Prostate Cancer
Time frame: Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days
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