Multiparametric MRI in Evaluating Cancer Stage and Helping Treatment Planning in Patients With Prostate Cancer
- Conditions
- Prostate Carcinoma
- Interventions
- Diagnostic Test: Multiparametric Magnetic Resonance Imaging
- Registration Number
- NCT03697148
- Lead Sponsor
- ECOG-ACRIN Cancer Research Group
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 852
- Recently diagnosed with prostate cancer for whom definitive surgical treatment is indicated
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diagnostic (mpMRI) Multiparametric Magnetic Resonance Imaging Patients undergo mpMRI within 3 months prior to schedule surgery.
- Primary Outcome Measures
Name Time Method Risk prediction model 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.
Diagnostic performance of overall prostate imaging reporting and data system (PI-RADS) score Up to 2 years Will estimate the diagnostic performance as quantified by the area under the ROC curve.
- Secondary Outcome Measures
Name Time Method Diagnostic performance of the individual prostate imaging reporting and data system (PI-RADS) score Up to 2 years Will estimate the diagnostic performance as quantified by the area under the ROC curve.
Trial Locations
- Locations (44)
Mayo Clinic Hospital in Arizona
🇺🇸Phoenix, Arizona, United States
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States
Yale University
🇺🇸New Haven, Connecticut, United States
University of Florida Health Science Center - Jacksonville
🇺🇸Jacksonville, Florida, United States
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States
Pali Momi Medical Center
🇺🇸'Aiea, Hawaii, United States
Straub Pearlridge Clinic
🇺🇸'Aiea, Hawaii, United States
Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
Straub Clinic and Hospital
🇺🇸Honolulu, Hawaii, United States
Midwestern Regional Medical Center
🇺🇸Zion, Illinois, United States
University of Kansas Cancer Center
🇺🇸Kansas City, Kansas, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
🇺🇸Grand Rapids, Michigan, United States
Henry Ford West Bloomfield Hospital
🇺🇸West Bloomfield, Michigan, 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
East Jefferson General Hospital
🇺🇸Metairie, Louisiana, United States
University of Kansas Hospital-Indian Creek Campus
🇺🇸Overland Park, Kansas, United States
NYP/Weill Cornell Medical Center
🇺🇸New York, New York, United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic
🇺🇸Metairie, Louisiana, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Mercy Hospital Saint Louis
🇺🇸Saint Louis, Missouri, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
UNC Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
Asante Rogue Regional Medical Center
🇺🇸Medford, Oregon, United States
Penn State Milton S Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt University/Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
MD Anderson in The Woodlands
🇺🇸Conroe, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas
🇺🇸Dallas, Texas, United States
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States
MD Anderson West Houston
🇺🇸Houston, Texas, United States
MD Anderson League City
🇺🇸League City, Texas, 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
MD Anderson in Sugar Land
🇺🇸Sugar Land, Texas, United States
West Virginia University Healthcare
🇺🇸Morgantown, West Virginia, United States
ProHealth Waukesha Memorial Hospital
🇺🇸Waukesha, Wisconsin, United States
UW Cancer Center at ProHealth Care
🇺🇸Waukesha, Wisconsin, United States