OBJECTIVES:
* Determine the efficacy of dutasteride followed by contrast-enhanced, ultrasound-guided targeted biopsy in detecting prostate cancer.
* Determine the detection rate of prostate cancer with targeted biopsy using contrast-enhanced ultrasound combined with dutasteride.
* Determine the efficacy of targeted biopsy using contrast-enhanced ultrasound vs systematic biopsy in diagnosing clinically significant prostate cancer.
* Determine the reduction in post-biopsy bleeding after dutasteride in these patients.
* Determine the cost effectiveness of this regimen in these patients.
OUTLINE: This is a prospective, double-blind, placebo-controlled, randomized study. Patients are randomized to 1 of 2 arms.
* Arm I: Patients receive oral dutasteride once daily on days 1-14.
* Arm II: Patients receive oral placebo once daily on days 1-14. On day 14, patients in both arms undergo blood collection and contrast-enhanced (perflutren protein-type A microspheres) transrectal ultrasound. Conventional gray-scale imaging, color Doppler imaging, and power Doppler imaging are performed. Biopsies are then performed; first up to 6 targeted ultrasound-guided biopsies and then up to 12 systematic biopsies.
After completion of study procedures, patients are followed at 1 day.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.
