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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-20

Study Completion Date

2026-04-30

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.

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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.

Conditions

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Prostate Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Diagnostic (bone scan, CT, MRI, magnetic resonance WB-DWI)

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.

Group Type EXPERIMENTAL

Bone Scan

Intervention Type PROCEDURE

Undergo bone scan

Computed Tomography

Intervention Type PROCEDURE

Undergo CT of the abdomen and pelvis

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo pelvic MRI

Magnetic Resonance Whole Body Diffusion-Weighted Imaging

Intervention Type PROCEDURE

Undergo magnetic resonance whole body diffusion-weighted imaging

Interventions

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Bone Scan

Undergo bone scan

Intervention Type PROCEDURE

Computed Tomography

Undergo CT of the abdomen and pelvis

Intervention Type PROCEDURE

Magnetic Resonance Imaging

Undergo pelvic MRI

Intervention Type PROCEDURE

Magnetic Resonance Whole Body Diffusion-Weighted Imaging

Undergo magnetic resonance whole body diffusion-weighted imaging

Intervention Type PROCEDURE

Other Intervention Names

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CAT CAT Scan Computerized Axial Tomography computerized tomography CT CT SCAN tomography Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging WB DW MRI WB-DWI Whole Body Magnetic Resonance Imaging Using Diffusion-Weighted Images Whole-Body Diffusion-Weighted MRI

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).

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No