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NCT03697148 Clinical Trial

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

Prostate Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03697148
Other study ID # EA8171
Secondary ID NCI-2017-01997EA
Status Recruiting
Phase N/A
First received
Last updated
Start date February 11, 2019
Est. completion date August 1, 2025

Study information
Verified date March 2024
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 852
Est. completion date August 1, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Multiparametric Magnetic Resonance Imaging
Undergo mpMRI

Locations
Country Name City State
United States Pali Momi Medical Center 'Aiea Hawaii
United States Straub Pearlridge Clinic 'Aiea Hawaii
United States Brigham and Women's Hospital Boston Massachusetts
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States MD Anderson in The Woodlands Conroe Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Henry Ford Hospital Detroit Michigan
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Penn State Milton S Hershey Medical Center Hershey Pennsylvania
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States M D Anderson Cancer Center Houston Texas
United States MD Anderson West Houston Houston Texas
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Mayo Clinic in Florida Jacksonville Florida
United States University of Florida Health Science Center - Jacksonville Jacksonville Florida
United States University of Kansas Cancer Center Kansas City Kansas
United States MD Anderson League City League City Texas
United States Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon New Hampshire
United States Rogue Valley Medical Center Medford Oregon
United States East Jefferson General Hospital Metairie Louisiana
United States LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie Louisiana
United States West Virginia University Healthcare Morgantown West Virginia
United States Vanderbilt University/Ingram Cancer Center Nashville Tennessee
United States Yale University New Haven Connecticut
United States NYP/Weill Cornell Medical Center New York New York
United States University of Kansas Hospital-Indian Creek Campus Overland Park Kansas
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania
United States Mayo Clinic Hospital in Arizona Phoenix Arizona
United States Mayo Clinic in Rochester Rochester Minnesota
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Audie L Murphy VA Hospital San Antonio Texas
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Mayo Clinic in Arizona Scottsdale Arizona
United States Stony Brook University Medical Center Stony Brook New York
United States MD Anderson in Sugar Land Sugar Land Texas
United States ProHealth Waukesha Memorial Hospital Waukesha Wisconsin
United States UW Cancer Center at ProHealth Care Waukesha Wisconsin
United States Henry Ford West Bloomfield Hospital West Bloomfield Michigan
United States Midwestern Regional Medical Center Zion Illinois

Sponsors (2)
Lead Sponsor Collaborator
ECOG-ACRIN Cancer Research Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Diagnostic performance of the individual 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
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