Prostate Cancer Detection Screening MRI Protocol

Prostate Cancer Detection Using a Quantitative Screening MRI Protocol

Whether a quantitative detection specfic magnetic resonance imaging (MRI) protocol improves prostate cancer (PCa) detection in biopsy naïve men is not adequately studied.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Ultrasound and MRI; Device: Ultrasound

Detailed Description

This will be a 2 arm prospective clinical trial. Men with clinical suspicion for PCa but no prior prostate biopsy will be enrolled from the University of Illinois (UI) Health Urology clinics. All eligible men will be screened and enrolled by the clinical research coordinator. Enrolled men will undergo detection protocol MRI at the UIC Advanced Imaging Center (AIC) prior to diagnostic biopsy. The MRI will be processed by the study team and evaluated for areas suspicious for high grade PCa by a board certified clinical radiologist. Subjects with MRI with no suspicious areas for high grade PCa will undergo standard of care (SOC) core transrectal ultrasound (TRUS) biopsy. Subject with MRI suspicious for high grade PCa will have 2-4 biopsies guided toward each suspicious lesion using MRI/TRUS fusion biopsies (maximum of 12 cores). All biopsies will undergo SOC histologic processing and interpretation in pathology. Biopsy results will be communicated to the patients by the Urologist performing the biopsy and all additional management will be SOC. This visit will signify the end of the study

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago Hospital and Ambulatory Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Adult men between 18 and 80 years of age
• Suspected PCa as defined by elevated PSA ≥4 ng/mL and ≤20 ng/mL and/or abnormal DRE as determined by a physician
• Ability to provide informed consent

Exclusion Criteria:

• Prior prostate biopsy
• Prior diagnosis of PCa
• MRI incompatible implanted medical devices or foreign bodies
• Rectal anatomy incompatible with TRUS biopsy
• Life expectancy <10 years as determined by the treating urologist

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: MRI and Ultrasound; men with elevated PSA or abnormal DRE for which prostate biopsy is indicated and mpMRI positive for suspected prostate cancer followed by MRI/ultrasound fusion directed prostate needle biopsies	Device: Ultrasound and MRI; A single subsequent ultrasound guided prostate biopsy with MRI fusion
OTHER: Ultrasound; men with elevated PSA or abnormal DRE for which prostate biopsy is indicated and mpMRI negative for suspected prostate cancer followed by standard ultrasound guided prostate needle biospies	Device: Ultrasound; A single subsequent ultrasound guided prostate biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Any Grade or High Grade (Gleason Score 7 or Higher) Prostate Cancer as Measured by Histopathology	Per subject prevalence of any grade or high grade (Gleason score 7 or higher) prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer	19 months
Number of Biopsy Samples With a Prevalence of High Grade (Gleason 7 or Higher) Prostate Cancer as Measured by Histopathology	Per biopsy sample prevalence of high grade (Gleason 7 or higher) prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer	19 months
Number of Participants With PI-RADS 4-5 on MRI	The accuracy of the mpMRI (PI-RADS version 2 score) to accurately characterize Gleason 7 or higher prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer	19 months
Number of Participants With PI-RADS <4 MRI	The accuracy of the mpMRI (PI-RADS version 2 score) to accurately characterize Gleason 7 or higher prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer	19 months
Number of Participants That Had Adverse Events	Adverse events of prostate biopsy using the Clavien-Dindo scale	19 months

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Investigators: Principal Investigator: Michael R Abern, MD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 20, 2019
• Primary Completion (ACTUAL): December 14, 2020
• Study Completion (ACTUAL): December 14, 2020

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (ACTUAL): November 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2019-0231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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.: No