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

Not Applicable

Active, not recruiting

• Conditions: Prostate Carcinoma
• Interventions: Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Magnetic Resonance Whole Body Diffusion-Weighted Imaging

• Registration Number: NCT03085043
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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 Timeline

• Study Start: 2016-04-20
• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-15
• Study First Posted: 2017-03-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 98

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (bone scan, CT, MRI, magnetic resonance WB-DWI)	Computed Tomography	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.
Diagnostic (bone scan, CT, MRI, magnetic resonance WB-DWI)	Bone Scan	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.
Diagnostic (bone scan, CT, MRI, magnetic resonance WB-DWI)	Magnetic Resonance Whole Body Diffusion-Weighted Imaging	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.
Diagnostic (bone scan, CT, MRI, magnetic resonance WB-DWI)	Magnetic Resonance Imaging	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.

Primary Outcome Measures

Name	Time	Method
Accuracy of whole body magnetic resonance imaging (MRI)	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.

Secondary Outcome Measures

Name	Time	Method
Sensitivity of MRI, bone scan, and CT scan	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.
Positive predictive value (PPV) of MRI, bone scan, and CT scan	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.
Negative predictive value (NPV) of MRI, bone scan, and CT scan	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.
Detection of other types of metastases	Up to 9 years	Comparisons between modalities will be performed using McNemar's test. Other statistical analyses will be carried out as appropriate.
Specificity of MRI, bone scan, and CT scan	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States