Accuracy of Targeted Biopsies Using MRI-TRUS Fusion Guidance: Pilot Study on Ex Vivo Radical Prostatectomy Specimens
I. To evaluate accuracy of the new image-guided targeted needle biopsy using the ex-vivo
human prostate as obtained from fresh radical prostatectomy specimens.
OUTLINE: Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion
image-guided prostate biopsies.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Number of times the first biopsy needle is placed within 3.0 mm of the center lesion
A likelihood ratio test will be used to test for independence among lesions within a prostate (corresponding to a lack of systematic MRI-TRUS image distortion and implying that, overall, 1st biopsies to a lesion within one prostate are as likely to accurate as in another prostate).
One month after last patient enrolled is taken off study
USC/Norris Comprehensive Cancer Center
United States: Federal Government
|USC Norris Comprehensive Cancer Center||Los Angeles, California 90089|