Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer

Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride

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