Prostate Cancer Detection Screening MRI Protocol

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

Detailed Description
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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

Official Title
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Prostate Cancer Detection Using a Quantitative Screening MRI Protocol

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Ultrasound and MRI
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 50 men with clinical suspicion of PCa (elevated Prostate specific antigen (PSA) and/or abnormal DRE) will be enrolled into a prospective protocol and will undergo detection protocol MRI
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MRI and Ultrasound<br>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<br>* A single subsequent ultrasound guided prostate biopsy with MRI fusion<br>|
| Other: Ultrasound<br>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<br>* A single subsequent ultrasound guided prostate biopsy<br>|

What is the study measuring?
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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 |