Accuracy of Targeted Biopsies Using MRI-TRUS Fusion Guidance: Pilot Study on Ex Vivo Radical Prostatectomy Specimens
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- University of Southern California
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Number of times the first biopsy needle is placed within 3.0 mm of the center lesion
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
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
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).
Secondary Outcomes
- Average distance of the second needle from the first needle minus 2.0 mm(One month after last patient enrolled is taken off study)
- Average distance of the third needle from the first needle minus 2.0 mm(One month after last patient enrolled is taken off study)
- Average distance of the first needle to the center of the lesion(One month after last patient enrolled is taken off study)