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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.
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
Age
18 - 80 years
Sex
MALE
Healthy Volunteers
No
University of Illinois at Chicago Hospital and Ambulatory Clinics
Chicago, Illinois, United States
Start Date
May 20, 2019
Primary Completion Date
December 14, 2020
Completion Date
December 14, 2020
Last Updated
June 9, 2022
48
ACTUAL participants
Ultrasound and MRI
DEVICE
Ultrasound
DEVICE
Lead Sponsor
University of Illinois at Chicago
NCT05691465
NCT04550494
Data Source & Attribution
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