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

March 27, 2024 updated by: ECOG-ACRIN Cancer Research Group

Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

852

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Suspended
        • Mayo Clinic Hospital in Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic in Arizona
        • Principal Investigator:
          • Akira Kawashima
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Active, not recruiting
        • Yale University
    • Florida
      • Jacksonville, Florida, United States, 32224-9980
        • Recruiting
        • Mayo Clinic in Florida
        • Principal Investigator:
          • Akira Kawashima
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida Health Science Center - Jacksonville
        • Contact:
        • Principal Investigator:
          • Dheeraj Reddy Gopireddy
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Active, not recruiting
        • Pali Momi Medical Center
      • 'Aiea, Hawaii, United States, 96701
        • Active, not recruiting
        • Straub Pearlridge Clinic
      • Honolulu, Hawaii, United States, 96813
        • Active, not recruiting
        • Queen's Medical Center
      • Honolulu, Hawaii, United States, 96813
        • Active, not recruiting
        • Straub Clinic and Hospital
    • Illinois
      • Zion, Illinois, United States, 60099
        • Active, not recruiting
        • Midwestern Regional Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University/Melvin and Bren Simon Cancer Center
        • Principal Investigator:
          • Temel Tirkes
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa/Holden Comprehensive Cancer Center
        • Principal Investigator:
          • Maheen Rajput
        • Contact:
          • Site Public Contact
          • Phone Number: 800-237-1225
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Cancer Center
        • Contact:
        • Principal Investigator:
          • William Parker
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • University of Kansas Hospital-Indian Creek Campus
        • Contact:
        • Principal Investigator:
          • William Parker
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • East Jefferson General Hospital
        • Contact:
        • Principal Investigator:
          • Scott E. Delacroix
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • LSU Healthcare Network / Metairie Multi-Specialty Clinic
        • Contact:
        • Principal Investigator:
          • Scott E. Delacroix
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Active, not recruiting
        • Brigham and Women's Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • Principal Investigator:
          • Haythem Y. Ali
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Spectrum Health at Butterworth Campus
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • West Bloomfield, Michigan, United States, 48322
        • Recruiting
        • Henry Ford West Bloomfield Hospital
        • Contact:
        • Principal Investigator:
          • Haythem Y. Ali
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Principal Investigator:
          • Akira Kawashima
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
      • Saint Louis, Missouri, United States, 63110
        • Suspended
        • Washington University School of Medicine
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Principal Investigator:
          • Lawrence M. Dagrosa
        • Contact:
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • NYP/Weill Cornell Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 212-746-1848
        • Principal Investigator:
          • Scott T. Tagawa
      • Stony Brook, New York, United States, 11794
        • Active, not recruiting
        • Stony Brook University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center
        • Principal Investigator:
          • Ersan Altun
        • Contact:
    • Oregon
      • Medford, Oregon, United States, 97504
        • Recruiting
        • Rogue Valley Medical Center
        • Contact:
        • Principal Investigator:
          • Liam C. Macleod
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Recruiting
        • Penn State Milton S Hershey Medical Center
        • Principal Investigator:
          • Nabeel Sarwani
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Fox Chase Cancer Center
        • Principal Investigator:
          • Syed Yasir Andrabi
        • Contact:
          • Site Public Contact
          • Phone Number: 215-728-4790
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania/Abramson Cancer Center
        • Principal Investigator:
          • Mitchell D. Schnall
        • Contact:
          • Site Public Contact
          • Phone Number: 800-474-9892
      • Philadelphia, Pennsylvania, United States, 19107
        • Active, not recruiting
        • Thomas Jefferson University Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University/Ingram Cancer Center
        • Principal Investigator:
          • Virginia Planz
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
    • Texas
      • Conroe, Texas, United States, 77384
        • Recruiting
        • MD Anderson in The Woodlands
        • Contact:
        • Principal Investigator:
          • Tharakeswara Bathala
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Principal Investigator:
          • Daniel N. Costa
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Tharakeswara Bathala
      • Houston, Texas, United States, 77079
        • Recruiting
        • MD Anderson West Houston
        • Contact:
        • Principal Investigator:
          • Tharakeswara Bathala
      • League City, Texas, United States, 77573
        • Recruiting
        • MD Anderson League City
        • Contact:
        • Principal Investigator:
          • Tharakeswara Bathala
      • San Antonio, Texas, United States, 78229
        • Active, not recruiting
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Audie L Murphy VA Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 877-469-5300
        • Principal Investigator:
          • Michael A. Liss
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • MD Anderson in Sugar Land
        • Contact:
        • Principal Investigator:
          • Tharakeswara Bathala
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University Healthcare
        • Principal Investigator:
          • Adam M. Luchey
        • Contact:
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188
        • Suspended
        • ProHealth Waukesha Memorial Hospital
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • UW Cancer Center at ProHealth Care
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (mpMRI)
Patients undergo mpMRI within 3 months prior to schedule surgery.
Diagnostic test: Multiparametric Magnetic Resonance Imaging
Undergo mpMRI
Other Names:
  • Multiparametric MRI
  • MP-MRI
  • Multi-parametric MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of overall prostate imaging reporting and data system (PI-RADS) score
Time Frame: Up to 2 years
Will estimate the diagnostic performance as quantified by the area under the ROC curve.
Up to 2 years
Risk prediction model
Time Frame: Up to 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of the individual prostate imaging reporting and data system (PI-RADS) score
Time Frame: Up to 2 years
Will estimate the diagnostic performance as quantified by the area under the ROC curve.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Clare Tempany-Afdhal, ECOG-ACRIN Cancer Research Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2019

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

July 10, 2018

First Submitted That Met QC Criteria

October 3, 2018

First Posted (Actual)

October 5, 2018

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA8171 (Other Identifier: CTEP)
  • U10CA180820 (U.S. NIH Grant/Contract)
  • NCI-2017-01997 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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