Conditions: Prostate Cancer
Keywords: Finasteride Placebo Prostate cancer Prostate Specific Antigen (PSA) Men at intermediate risk of prostate cancer Men scheduled for prostate biopsy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 383
Healthy volunteers: no

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.

Arms:
arm 1: Finasteride 5mg tablets every day by mouth for 3 months arm 2: Placebo 5mg tablet every day by mouth for 3 months

Interventions: intervention 1: Finasteride intervention 2: Placebo
Intervention descriptions: intervention 1: Finasteride 5mg every day by mouth for 3 months intervention 2: Placebo every day by mouth for 3 months

Protocol document: