NCT03085043

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

10 years

First QC Date

March 15, 2017

Last Update Submit

March 3, 2026

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Sensitivity of MRI, bone scan, and CT scan

    Up to 9 years

  • Specificity of MRI, bone scan, and CT scan

    Up to 9 years

  • Positive predictive value (PPV) of MRI, bone scan, and CT scan

    Up to 9 years

  • Negative predictive value (NPV) of MRI, bone scan, and CT scan

    Up to 9 years

  • Detection of other types of metastases

    Up to 9 years

Study Arms (1)

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

EXPERIMENTAL

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 ScanProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Magnetic Resonance Whole Body Diffusion-Weighted Imaging

Interventions

Bone ScanPROCEDURE

Undergo bone scan

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

Undergo CT of the abdomen and pelvis

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography
Diagnostic (bone scan, CT, MRI, magnetic resonance WB-DWI)
Magnetic Resonance ImagingPROCEDURE

Undergo pelvic MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Diagnostic (bone scan, CT, MRI, magnetic resonance WB-DWI)
Magnetic Resonance Whole Body Diffusion-Weighted ImagingPROCEDURE

Undergo magnetic resonance whole body diffusion-weighted imaging

Also known as: WB DW MRI, WB-DWI, Whole Body Magnetic Resonance Imaging Using Diffusion-Weighted Images, Whole-Body Diffusion-Weighted MRI
Diagnostic (bone scan, CT, MRI, magnetic resonance WB-DWI)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Tharakeswara K Bathala

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2017

First Posted

March 21, 2017

Study Start

April 20, 2016

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

US(1)