Spots Global Cancer Trial Database for 3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer

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Trial Identification

Brief Title: 3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer

Official Title: Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test

Study ID: NCT01296672

Conditions

Prostate Cancer

Interventions

Finasteride

Placebo

Study Description

Brief Summary: 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.

Detailed Description: 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.