Prostate Cancer Detection Screening MRI Protocol

Prostate Cancer Clinical Trial

Official title:

Prostate Cancer Detection Using a Quantitative Screening MRI Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04175730
• Other study ID #: 2019-0231
• Status: Completed
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: December 14, 2020

Study information

• Verified date: May 2022
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 14, 2020
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Ultrasound and MRI
A single subsequent ultrasound guided prostate biopsy with MRI fusion
• Ultrasound
A single subsequent ultrasound guided prostate biopsy

Locations

Country	Name	City	State
United States	University of Illinois at Chicago Hospital and Ambulatory Clinics	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of Participants That Had Adverse Events	Adverse events of prostate biopsy using the Clavien-Dindo scale	19 months