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

• Number of times the first biopsy needle is placed within 3.0 mm of the center lesion [ Time Frame: One month after last patient enrolled is taken off study ] [ Designated as safety issue: No ]
  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).
• Number of times the second biopsy needle is placed within 3.0 mm of the center lesion [ Time Frame: One month after last patient enrolled is take off study ] [ Designated as safety issue: No ]
  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).

• Average distance of the first needle to the center of the lesion [ Time Frame: One month after last patient enrolled is taken off study ] [ Designated as safety issue: No ]
  A nested (random effects) analysis of variance (ANOVA) will be used to analyze the distance of the first needle from the center of the lesion. Standard error or 95% confidence interval will be calculated.
• Average distance of the second needle from the first needle minus 2.0 mm [ Time Frame: One month after last patient enrolled is taken off study ] [ Designated as safety issue: No ]
  A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion.
• Average distance of the third needle from the first needle minus 2.0 mm [ Time Frame: One month after last patient enrolled is taken off study ] [ Designated as safety issue: No ]
  A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion.

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.

• Procedure: therapeutic conventional surgery
  Undergo robotic radical prostatectomy
• Procedure: ultrasound-guided prostate biopsy
  Undergo MRI-TRUS fusion image-guided prostate biopsy
• Procedure: magnetic resonance imaging
  Undergo MRI-TRUS fusion image-guided prostate biopsy
  Other Names:

  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging

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