Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Image-Guided Prostate Biopsy Following Radical Prostatectomy in Patients With Prostate Cancer

Accuracy of Targeted Biopsies Using MRI-TRUS Fusion Guidance: Pilot Study on Ex Vivo Radical Prostatectomy Specimens

This pilot clinical trial studies magnetic resonance imaging (MRI)-transrectal ultrasound (TRUS) fusion image-guided prostate biopsy following radical prostatectomy in patients with prostate cancer. Diagnostic procedures, such as MRI-TRUS fusion image-guided prostate biopsy may help find and diagnose prostate cancer

PRIMARY OBJECTIVES:

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.

Inclusion Criteria:

• Subjects must have biopsy-proven prostate cancer, or prostate-specific antigen (PSA) >= 4 ng/ml or an abnormal digital rectal examination (DRE) if consented before prostate biopsy
• Subjects must have at least 2, preferably 3, pre-operative magnetic resonance imaging (MRI)-identified malignant or benign lesions that measure between 10 mm and 15 mm in diameter within the prostate
• Subjects must have decided to have their prostate surgically removed

Exclusion Criteria:

• Patients who do not give informed consent
• Patients with extracapsular extension of their prostate cancer