Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer

RATIONALE: Diagnostic procedures, such as ultrasound-guided biopsy, may help find prostate cancer. Dutasteride may improve the ability of ultrasound-guided biopsy to find prostate cancer. It is not yet known whether dutasteride followed by ultrasound-guided biopsy is more effective than a placebo followed by ultrasound-guided biopsy in finding prostate cancer. PURPOSE: This randomized phase III trial is studying dutasteride and ultrasound-guided biopsy to see how well they find prostate cancer compared with a placebo and ultrasound-guided biopsy.

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.

DISEASE CHARACTERISTICS: Suspected prostate cancer due to 1 of the following criteria: Prior abnormal digital rectal exam Elevated prostate-specific antigen (PSA) ≥ 2.6 ng/mL within the past 90 days PSA velocity > 0.75 ng/mL/year Must be planning to undergo a transrectal ultrasound with biopsy PATIENT CHARACTERISTICS: Must be in adequate physical health to tolerate a prolonged transrectal examination and biopsy Must not be clinically unstable, severely ill, or moribund PRIOR CONCURRENT THERAPY: More than 30 days since prior biopsy of the prostate More than 1 week since prior acetylsalicylic acid or blood thinner More than 30 days since prior participation in a clinical trial involving an investigational drug No prior therapy for prostate cancer No other concurrent 5-alpha reductase inhibitor

Halpern EJ, Gomella LG, Forsberg F, McCue PA, Trabulsi EJ. Contrast enhanced transrectal ultrasound for the detection of prostate cancer: a randomized, double-blind trial of dutasteride pretreatment. J Urol. 2012 Nov;188(5):1739-45. doi: 10.1016/j.juro.2012.07.021. Epub 2012 Sep 19.