Magnetic Resonance Whole Body Diffusion-Weighted Imaging in Finding Bone or Lymph Node Metastasis in Participants With High-Risk Prostate Cancer

Study Overview
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Brief Summary
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This trial studies how well magnetic resonance whole body diffusion-weighted imaging works in finding cancer that has spread to the bone or lymph nodes (metastasis) in participants with high-risk prostate cancer. Diagnostic procedures, such as magnetic resonance whole body diffusion-weighted imaging (a method to show how water moves in a certain area) may help find bone or lymph nodes metastasis.

Detailed Description
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PRIMARY OBJECTIVES: I. To compare accuracies of whole body magnetic resonance imaging (MRI) versus bone scan plus computed tomography (CT) scan in detecting bone or lymph node metastasis in high risk prostate cancer patients. OUTLINE: Participants undergo standard of care bone scan, CT of the abdomen and pelvis, and pelvic MRI. Participants also undergo magnetic resonance whole body (WB)-diffusion-weighted imaging (DWI) over 20-30 minutes.

Official Title
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Magnetic Resonance Imaging as a Comprehensive Staging Tool for the Evaluation of High-Risk Prostate Carcinoma

Conditions
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Prostate Carcinoma

Intervention / Treatment
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* Procedure: Bone Scan
* Procedure: Computed Tomography
* Procedure: Magnetic Resonance Imaging
* Procedure: Magnetic Resonance Whole Body Diffusion-Weighted Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prostate carcinoma patients at high risk for metastasis with prostate-specific antigen (PSA) more than 20 ng/ml and/or Gleason score = 8/ > 8. Ability to understand and sign informed consent. Exclusion Criteria: Patient is at low risk for metastasis with Gleason score at diagnosis < 8. Currently receiving or history of systemic therapy with testosterone suppressing medication (i.e., lupron, degarelix, abiraterone, enzalutamide) or local radiation therapy. Contraindication to magnetic resonance imaging (MRI).

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (bone scan, CT, MRI, magnetic resonance WB-DWI)<br>Participants undergo standard of care bone scan, CT of the abdomen and pelvis, and pelvic MRI. Participants also undergo magnetic resonance WB-DWI over 20-30 minutes. | Procedure: Bone Scan<br>* Undergo bone scan<br>Procedure: Computed Tomography<br>* Undergo CT of the abdomen and pelvis<br>* Other names: tomography;Procedure: Magnetic Resonance Imaging<br>* Undergo pelvic MRI<br>* Other names: Nuclear Magnetic Resonance Imaging;Procedure: Magnetic Resonance Whole Body Diffusion-Weighted Imaging<br>* Undergo magnetic resonance whole body diffusion-weighted imaging<br>* Other names: Whole-Body Diffusion-Weighted MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of whole body magnetic resonance imaging (MRI) | Accuracy will be estimated along with 95% confidence intervals for whole body MRI (for bone and lymph node metastasis), bone scan (for bone metastasis), and computed tomography (CT) scan (for lymph node metastasis). Comparisons between modalities will be performed using McNemar's test. Other statistical analyses will be carried out as appropriate. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of MRI, bone scan, and CT scan | Sensitivity will be estimated along with 95% confidence intervals for whole body MRI (for bone and lymph node metastasis), bone scan (for bone metastasis), and CT scan (for lymph node metastasis). Comparisons between modalities will be performed using McNemar's test. Other statistical analyses will be carried out as appropriate. | Up to 9 years | 
| Specificity of MRI, bone scan, and CT scan | Specificity will be estimated along with 95% confidence intervals for whole body MRI (for bone and lymph node metastasis), bone scan (for bone metastasis), and CT scan (for lymph node metastasis). Comparisons between modalities will be performed using McNemar's test. Other statistical analyses will be carried out as appropriate. | Up to 9 years | 
| Positive predictive value (PPV) of MRI, bone scan, and CT scan | PPV will be estimated along with 95% confidence intervals for whole body MRI (for bone and lymph node metastasis), bone scan (for bone metastasis), and CT scan (for lymph node metastasis). Comparisons between modalities will be performed using McNemar's test. Other statistical analyses will be carried out as appropriate. | Up to 9 years | 
| Negative predictive value (NPV) of MRI, bone scan, and CT scan | NPV will be estimated along with 95% confidence intervals for whole body MRI (for bone and lymph node metastasis), bone scan (for bone metastasis), and CT scan (for lymph node metastasis). Comparisons between modalities will be performed using McNemar's test. Other statistical analyses will be carried out as appropriate. | Up to 9 years | 
| Detection of other types of metastases | Comparisons between modalities will be performed using McNemar's test. Other statistical analyses will be carried out as appropriate. | Up to 9 years |