An Investigational Scan (MRI With Dixon Based Sequences) in Detecting Prostate Cancer

Study Overview
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Brief Summary
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This trial studies the use of magnetic resonance imaging (MRI) with Dixon based imaging sequences in detecting prostate cancer. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. Researchers hope to learn if using a modified MRI scan technique with Dixon based imaging sequencing will help to produce better images of prostate cancer than the standard of care MRI scan technique.

Detailed Description
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PRIMARY OBJECTIVES: I. Evaluate prospectively the accuracy of Dixon based sequences in detection of intraprostatic tumor nodules. II. Determine the sensitivity, specificity, positive and negative predictive value of Dixon based sequences in assessment of extraprostatic tumor extension and lymph node involvement. SECONDARY OBJECTIVES: I. Compare the accuracy of Dixon based sequences versus multiparametric diffusion weighted imaging including diffusion tensor imaging in tumor detection and extraprostatic extension. II. Compare the accuracy of Dixon based sequences in detection of transition zone tumors. III. Determine the optimal scanning parameters for Dixon based sequences in the imaging of prostate adenocarcinoma. OUTLINE: Patients undergo MRI with additional Dixon based sequences with fat and water over a total of 49 minutes.

Official Title
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Evaluation of MRI With Dixon Based Sequences in the Detection of Prostate Cancer

Conditions
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Prostate Carcinoma

Intervention / Treatment
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* Procedure: Dixon MRI
* Procedure: Magnetic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy proven prostate cancer patients who are scheduled to undergo prostatectomy. Patient who is scheduled to have a clinically indicated staging endorectal prostate MRI exam. Patients who have signed their informed consent form to undergo the study. Exclusion Criteria: Known prior hormone ablation or radiation therapy (pelvic or prostate). Patients who do not want to undergo prostatectomy and prefer other therapy or surveillance. Contraindication to conventional MR imaging (e. g. metal implants, pace maker, etc.).

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 (standard MRI, Dixon MRI)<br>Patients undergo MRI with additional Dixon based sequences with fat and water over a total of 49 minutes. | Procedure: Dixon MRI<br>* Undergo Dixon MRI<br>* Other names: Dixon Fat-Suppression MRI;Procedure: Magnetic Resonance Imaging<br>* Undergo standard MRI<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 |
| --- | --- | --- |
| Detection of at least one or more prostate lesions with Dixon sequencing | Will evaluate and compare the accuracy of Dixon based sequencing to the conventional T2 weighted sequencing for detection of intraprostatic tumor and extraprostatic tumor extension. Lesions will be within any of six regions of the prostate: left apex, left mid, left base, right apex, right mid, and right base. The relative sensitivity and specificity of the two sequencing methods will be compared using an adjusted McNemar's test for clustered data where clusters consist of the matched pairs of within patient-zone observations. The primary analysis will also provide 95% confidence intervals for marginal sensitivity and specificity using a generalized linear mixed model. | through study completion, an average of 1 year |