NCT01296672

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

Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 383 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: Male
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Finasteride	Finasteride 5mg every day by mouth for 3 months
DRUG	Placebo	Placebo every day by mouth for 3 months

Timeline

• Start date: 2011-02-01
• Primary completion: 2016-11-01
• Completion: 2017-01-01
• First posted: 2011-02-15
• Last updated: 2017-10-06
• Results posted: 2017-09-08

Locations

1 site across 1 country: United States