NCT04175730

Prostate Cancer Detection Screening MRI Protocol

Prostate Cancer Detection Using a Quantitative Screening MRI Protocol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	Ultrasound and MRI	A single subsequent ultrasound guided prostate biopsy with MRI fusion
DEVICE	Ultrasound	A single subsequent ultrasound guided prostate biopsy

Timeline

• Start date: 2019-05-20
• Primary completion: 2020-12-14
• Completion: 2020-12-14
• First posted: 2019-11-25
• Last updated: 2022-06-09
• Results posted: 2022-06-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study