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

Trial Status: Active

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.

Inclusion Criteria

  • Diagnosed within 120 days prior to registration with prostate cancer for whom definitive surgical treatment is indicated
  • Confirmation of payment, insurance pre-authorization, or Medicare certification for mpMRI

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
  • Unable to obtain confirmation of payment, insurance pre-authorization, or Medicare certification for mpMRI

Arizona

Phoenix
Mayo Clinic Hospital in Arizona
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Scottsdale
Mayo Clinic in Arizona
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015

Connecticut

New Haven
Yale University
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-785-5702

Florida

Jacksonville
Mayo Clinic in Florida
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015

Hawaii

Honolulu
Queen's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-545-8548

Illinois

Zion
Midwestern Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-823-5923

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 317-278-5632

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-237-1225

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Overland Park
University of Kansas Hospital-Indian Creek Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671

Louisiana

Metairie
East Jefferson General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-210-3539
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-210-3539

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 617-724-5200

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015

Missouri

Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7066
Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606

New York

New York
NYP / Weill Cornell Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-746-1848

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-668-0683

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-728-4790
Thomas Jefferson University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-955-6084
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-474-9892

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-811-8480

Texas

Conroe
MD Anderson in The Woodlands
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-632-6789
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: APPROVED
Contact: Site Public Contact
Phone: 214-648-7097
Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789
MD Anderson West Houston
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789
League City
MD Anderson League City
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789
San Antonio
Audie L Murphy VA Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-469-5300
University of Texas Health Science Center at San Antonio
Status: ACTIVE
Contact: Site Public Contact
Phone: 210-450-3800
Sugar Land
MD Anderson in Sugar Land
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789

West Virginia

Morgantown
West Virginia University Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-293-7374

Wisconsin

Waukesha
ProHealth Waukesha Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 262-928-7632
UW Cancer Center at ProHealth Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-5539

PRIMARY OBJECTIVES:

I. To estimate the diagnostic performance of overall prostate imaging reporting and data system (PI-RADS) score based on local site imaging review of multiparametric (mp)MRI (T2 weighted [2W], diffusion weighted imaging [DWI] and dynamic contrast-enhanced [DCE]) to detect clinically significant 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 clinically significant prostate cancer.

SECONDARY OBJECTIVE:

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.

EXPLORATORY OBJECTIVE:

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

EXPLORATORY TOBACCO USE OBJECTIVES:

I. To determine the effects of tobacco, operationalized as combustible tobacco (1a), other forms of tobacco (1b), and environmental tobacco exposure (ETS) (1c) on provider-reported cancer-treatment toxicity (adverse events [both clinical and hematologic]) and dose modifications.

II. To determine the effects of tobacco on patient-reported physical symptoms and psychological symptoms.

III. To examine quitting behaviors and behavioral counseling/ support and cessation medication utilization.

IV. To explore the effect of tobacco use and exposure on treatment duration, relative dose intensity, and therapeutic benefit.

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.

Trial Phase Phase II

Trial Type Diagnostic

Lead Organization
ECOG-ACRIN Cancer Research Group

Principal Investigator
Clare M.C. Tempany-Afdhal

  • Primary ID EA8171
  • Secondary IDs NCI-2017-01997
  • Clinicaltrials.gov ID NCT03697148