NCT03697148

Brief Summary

This phase II trial studies how well multiparametric magnetic resonance imaging (MRI) works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive disease.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
852

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

44 active sites

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 Progress96%
Feb 2019Aug 2026

First Submitted

Initial submission to the registry

July 10, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 11, 2019

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

7.6 years

First QC Date

July 10, 2018

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Diagnostic performance of overall prostate imaging reporting and data system (PI-RADS) score

    Will estimate the diagnostic performance as quantified by the area under the ROC curve.

    Up to 2 years

  • Risk prediction model

    To estimate the predictive performance of a model for predicting clinically significant prostate cancer on the basis of the overall PI-RADS, PSA, Gleason score and clinical stage.

    Up to 2 years

Secondary Outcomes (1)

  • Diagnostic performance of the individual prostate imaging reporting and data system (PI-RADS) score

    Up to 2 years

Study Arms (1)

Diagnostic (mpMRI)

EXPERIMENTAL

Patients undergo mpMRI within 3 months prior to schedule surgery.

Diagnostic Test: Multiparametric Magnetic Resonance Imaging

Interventions

Undergo mpMRI

Also known as: MP-MRI, Multi-parametric MRI, Multiparametric MRI
Diagnostic (mpMRI)

Eligibility Criteria

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

You may qualify if:

  • Recently diagnosed with prostate cancer for whom definitive surgical treatment is indicated

You may not qualify if:

  • Not suitable to undergo MRI or receive gadolinium-based contrast agent (severe, untreatable claustrophobia; MRI-incompatible metallic objects or implanted medical devices; renal failure; weight greater than allowable by scanner per institutional standard practice)
  • Prior surgical and/or non-surgical treatment for prostate cancer
  • Prior hip replacement or other major pelvic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (44)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

University of Florida Health Science Center - Jacksonville

Jacksonville, Florida, 32209, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Straub Clinic and Hospital

Honolulu, Hawaii, 96813, United States

Location

Pali Momi Medical Center

‘Aiea, Hawaii, 96701, United States

Location

Straub Pearlridge Clinic

‘Aiea, Hawaii, 96701, United States

Location

Midwestern Regional Medical Center

Zion, Illinois, 60099, United States

Location

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, 66211, United States

Location

East Jefferson General Hospital

Metairie, Louisiana, 70006, United States

Location

LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana, 70006, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503, United States

Location

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

Location

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

NYP/Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Asante Rogue Regional Medical Center

Medford, Oregon, 97504, United States

Location

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MD Anderson in The Woodlands

Conroe, Texas, 77384, United States

Location

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MD Anderson West Houston

Houston, Texas, 77079, United States

Location

MD Anderson League City

League City, Texas, 77573, United States

Location

Audie L Murphy VA Hospital

San Antonio, Texas, 78229, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MD Anderson in Sugar Land

Sugar Land, Texas, 77478, United States

Location

West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States

Location

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188, United States

Location

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Resonance ImagingTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Clare Tempany-Afdhal

    ECOG-ACRIN Cancer Research Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2018

First Posted

October 5, 2018

Study Start

February 11, 2019

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations