Prostate Cancer Detection Screening MRI Protocol

NCT ID: NCT04175730

Last Updated: 2022-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-20
• Study Completion Date: 2020-12-14

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

MRI and Ultrasound

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

Group Type: OTHER

Ultrasound and MRI

Intervention Type: DEVICE

A single subsequent ultrasound guided prostate biopsy with MRI fusion

Ultrasound

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

Group Type: OTHER

Ultrasound

Intervention Type: DEVICE

A single subsequent ultrasound guided prostate biopsy

Interventions

Ultrasound and MRI

A single subsequent ultrasound guided prostate biopsy with MRI fusion

Intervention Type: DEVICE

Ultrasound

A single subsequent ultrasound guided prostate biopsy

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Michael R Abern

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael R Abern, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois at Chicago Hospital and Ambulatory Clinics

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019-0231

Identifier Type: -

Identifier Source: org_study_id