Prostate Cancer Clinical Trial

Prostate Cancer Detection Screening MRI Protocol

Summary

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

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Full 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

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Prostate Cancer

Estimated Enrollment:

48

Study ID:

NCT04175730

Recruitment Status:

Completed

Sponsor:

University of Illinois at Chicago

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There is 1 Location for this study

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

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

48

Study ID:

NCT04175730

Recruitment Status:

Completed

Sponsor:


University of Illinois at Chicago

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