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

March 3, 2026 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Bone Scan
Undergo bone scan
Procedure: Computed Tomography
Undergo CT of the abdomen and pelvis
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • tomography
  • computerized tomography
  • CT SCAN
Procedure: Magnetic Resonance Imaging
Undergo pelvic MRI
Other Names:
  • MRI
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
Procedure: Magnetic Resonance Whole Body Diffusion-Weighted Imaging
Undergo magnetic resonance whole body diffusion-weighted imaging
Other Names:
  • WB DW MRI
  • WB-DWI
  • Whole Body Magnetic Resonance Imaging Using Diffusion-Weighted Images
  • Whole-Body Diffusion-Weighted MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of whole body magnetic resonance imaging (MRI)
Time Frame: Up to 6 months
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
Time Frame: Up to 9 years
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
Time Frame: Up to 9 years
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
Time Frame: Up to 9 years
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
Time Frame: Up to 9 years
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
Time Frame: Up to 9 years
Comparisons between modalities will be performed using McNemar's test. Other statistical analyses will be carried out as appropriate.
Up to 9 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Tharakeswara K Bathala, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2016

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

March 15, 2017

First Submitted That Met QC Criteria

March 15, 2017

First Posted (Actual)

March 21, 2017

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0053 (Other Identifier: M D Anderson Cancer Center)
  • P30CA016672 (U.S. NIH Grant/Contract)
  • NCI-2018-01308 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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