Multiparametric MRI in Evaluating Cancer Stage and Helping Treatment Planning in Patients With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This phase II trial studies how well multiparametric magnetic resonance imaging (MRI) works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive disease.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To estimate the diagnostic performance as quantified by the area under the ROC curve to detect aggressive prostate cancer. II. To develop a risk prediction model by incorporating overall PI-RADS, PSA, Gleason score and clinical stage to predict the presence of aggressive prostate cancer. SECONDARY OBJECTIVES: I. To evaluate the diagnostic performance of the individual PI-RADS score of each MRI parameter (T2W, DWI and DCE), as determined by local imaging review. TERTIARY OBJECTIVES: I. All clinical data including magnetic resonance (MR) images will be banked for future exploratory research aims. OUTLINE: Patients undergo mpMRI within 3 months prior to schedule surgery. After completion of study, patients are followed up until radical prostatectomy pathology is reported and finalized.

Official Title
-----------------
Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer

Conditions
-----------------
Prostate Carcinoma

Intervention / Treatment
-----------------
* Diagnostic Test: Multiparametric Magnetic Resonance Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recently diagnosed with prostate cancer for whom definitive surgical treatment is indicated Exclusion Criteria: Not suitable to undergo MRI or receive gadolinium-based contrast agent (severe, untreatable claustrophobia; MRI-incompatible metallic objects or implanted medical devices; renal failure; weight greater than allowable by scanner per institutional standard practice) Prior surgical and/or non-surgical treatment for prostate cancer Prior hip replacement or other major pelvic surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (mpMRI)<br>Patients undergo mpMRI within 3 months prior to schedule surgery. | Diagnostic Test: Multiparametric Magnetic Resonance Imaging<br>* Undergo mpMRI<br>* Other names: Multiparametric MRI;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of overall prostate imaging reporting and data system (PI-RADS) score | Will estimate the diagnostic performance as quantified by the area under the ROC curve. | Up to 2 years | 
| Risk prediction model | To estimate the predictive performance of a model for predicting clinically significant prostate cancer on the basis of the overall PI-RADS, PSA, Gleason score and clinical stage. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of the individual prostate imaging reporting and data system (PI-RADS) score | Will estimate the diagnostic performance as quantified by the area under the ROC curve. | Up to 2 years |