Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer

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