Diffusion-Weighted MRI in Staging Patients With Localized Prostate Cancer

Study Overview
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Brief Summary
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This pilot clinical trial studies how well diffusion-weighted magnetic resonance imaging (MRI) works in staging patients with prostate cancer that has not spread to nearby lymph nodes or other parts of the body. New imaging techniques, such as diffusion-weighted MRI, may be a less invasive way of predicting the stage and grade of prostate cancer.

Detailed Description
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PRIMARY OBJECTIVES: I. To determine the sensitivity and specificity of diffusion-weighted MRI for pathologic T3 stage prostate cancer using a 3 Tesla (3T) magnet with a surface coil. OUTLINE: Patients undergo diffusion-weighted MRI of the pelvis.

Official Title
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Diffusion-Weighted MRI for Staging in Localized Prostate Cancer: A Pilot Study

Conditions
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Adenocarcinoma of the Prostate, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

Intervention / Treatment
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* Procedure: diffusion-weighted magnetic resonance imaging
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy-documented adenocarcinoma of the prostate which is intermediate or high risk, defined as possessing one or more of the following features: Gleason >= 7 > 50% biopsy cores + Prostate-specific antigen (PSA) >= 10 Interested in undergoing a radical prostatectomy as definitive management for prostate cancer No clinical or radiographic evidence for distant metastatic disease In subjects with PSA < 20 no radiographic staging is required in the absence of clinical symptoms for distant metastatic disease; for those with PSA > 20, a bone scan must document lack of concern for bone involvement Exclusion Criteria: Ineligible for surgery due to cardiac, pulmonary, or other major comorbidity factor History of claustrophobia Pacemaker or other implanted metal objects which would make subject ineligible for MRI, per standard criteria Unable to give written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

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 (diffusion-weighted MRI)<br>Patients undergo diffusion-weighted MRI of the pelvis. | Procedure: diffusion-weighted magnetic resonance imaging<br>* Undergo diffusion-weighted MRI<br>* Other names: diffusion-weighted MRI;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients found to have extracapsular extension and seminal vesicle involvement using Diffusion-Weighted MRI | Patients will be imaged using diffusion-weighted MR. Findings will be correlated with histopathologic findings at biopsy and/or prostatectomy. | Baseline |