Prostate Cancer
Conditions
Keywords
prostate cancer
Brief summary
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
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.
Interventions
DRUGdutasteride
Given orally
OTHERplacebo
Given orally
Sponsors
National Cancer Institute (NCI)
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Primary purpose
DIAGNOSTIC
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of short-term dutasteride in improving prostate cancer detection | — |
| Detection rate of prostate cancer | — |
| Cost effectiveness of contrast-enhanced ultrasound | — |
Countries
United States
Outcome results
None listed