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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: therapeutic conventional surgery
* Procedure: ultrasound-guided prostate biopsy
* Procedure: magnetic resonance imaging


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (MRI-TRUS fusion image-guided biopsy)<br>Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies. | Procedure: therapeutic conventional surgery<br>* Undergo robotic radical prostatectomy<br>Procedure: ultrasound-guided prostate biopsy<br>* Undergo MRI-TRUS fusion image-guided prostate biopsy<br>Procedure: magnetic resonance imaging<br>* Undergo MRI-TRUS fusion image-guided prostate biopsy<br>* Other names: nuclear magnetic resonance imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of times the second 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 take off study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average distance of the first needle to the center of the lesion | 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. | One month after last patient enrolled is taken off study | 
| Average distance of the second needle from the first needle minus 2.0 mm | A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion. | One month after last patient enrolled is taken off study | 
| Average distance of the third needle from the first needle minus 2.0 mm | A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion. | One month after last patient enrolled is taken off study |