Multiparametric MRI in Evaluating Cancer Stage and Helping Treatment Planning in Patients With Prostate Cancer

NCT ID: NCT03697148

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

852 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-11

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVES:

I. To estimate the diagnostic performance as quantified by the area under the ROC curve to detect aggressive prostate cancer.

II. To develop a risk prediction model by incorporating overall PI-RADS, PSA, Gleason score and clinical stage to predict the presence of aggressive prostate cancer.

SECONDARY OBJECTIVES:

I. To evaluate the diagnostic performance of the individual PI-RADS score of each MRI parameter (T2W, DWI and DCE), as determined by local imaging review.

TERTIARY OBJECTIVES:

I. All clinical data including magnetic resonance (MR) images will be banked for future exploratory research aims.

OUTLINE:

Patients undergo mpMRI within 3 months prior to schedule surgery.

After completion of study, patients are followed up until radical prostatectomy pathology is reported and finalized.

Conditions

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Prostate Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (mpMRI)

Patients undergo mpMRI within 3 months prior to schedule surgery.

Group Type EXPERIMENTAL

Multiparametric Magnetic Resonance Imaging

Intervention Type DIAGNOSTIC_TEST

Undergo mpMRI

Interventions

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Multiparametric Magnetic Resonance Imaging

Undergo mpMRI

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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MP-MRI Multi-parametric MRI Multiparametric MRI

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

ECOG-ACRIN Cancer Research Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clare Tempany-Afdhal

Role: PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Locations

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Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Site Status

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

University of Florida Health Science Center - Jacksonville

Jacksonville, Florida, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Queen's Medical Center

Honolulu, Hawaii, United States

Site Status

Straub Clinic and Hospital

Honolulu, Hawaii, United States

Site Status

Pali Momi Medical Center

‘Aiea, Hawaii, United States

Site Status

Straub Pearlridge Clinic

‘Aiea, Hawaii, United States

Site Status

Midwestern Regional Medical Center

Zion, Illinois, United States

Site Status

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Site Status

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Site Status

University of Kansas Cancer Center

Kansas City, Kansas, United States

Site Status

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, United States

Site Status

East Jefferson General Hospital

Metairie, Louisiana, United States

Site Status

LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Site Status

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Site Status

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Site Status

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Site Status

NYP/Weill Cornell Medical Center

New York, New York, United States

Site Status

Stony Brook University Medical Center

Stony Brook, New York, United States

Site Status

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Site Status

Asante Rogue Regional Medical Center

Medford, Oregon, United States

Site Status

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

MD Anderson in The Woodlands

Conroe, Texas, United States

Site Status

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status

M D Anderson Cancer Center

Houston, Texas, United States

Site Status

MD Anderson West Houston

Houston, Texas, United States

Site Status

MD Anderson League City

League City, Texas, United States

Site Status

Audie L Murphy VA Hospital

San Antonio, Texas, United States

Site Status

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

MD Anderson in Sugar Land

Sugar Land, Texas, United States

Site Status

West Virginia University Healthcare

Morgantown, West Virginia, United States

Site Status

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, United States

Site Status

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2017-01997

Identifier Type: REGISTRY

Identifier Source: secondary_id

EA8171

Identifier Type: OTHER

Identifier Source: secondary_id

EA8171

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180820

Identifier Type: NIH

Identifier Source: secondary_id

View Link

EA8171

Identifier Type: -

Identifier Source: org_study_id