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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Prostate Carcinoma

Treatments: Procedure: Magnetic Resonance Imaging; Procedure: Magnetic Resonance Whole Body Diffusion-Weighted Imaging; Procedure: Computed Tomography; Procedure: Bone Scan

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03085043

P30CA016672 (U.S. NIH Grant/Contract)

NCI-2018-01308 (Registry Identifier)

2015-0053 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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98 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Procedure: Bone Scan

Procedure: Computed Tomography

Procedure: Magnetic Resonance Whole Body Diffusion-Weighted Imaging

Procedure: Magnetic Resonance Imaging