Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: dutasteride
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive oral dutasteride once daily on days 1-14. | Drug: dutasteride<br>* Given orally<br>|
| Placebo Comparator: Arm II<br>Patients receive oral placebo once daily on days 1-14. | Other: placebo<br>* Given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of short-term dutasteride in improving prostate cancer detection |  |  | 
| Detection rate of prostate cancer |  |  | 
| Cost effectiveness of contrast-enhanced ultrasound |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer