Prostate Cancer Detection Screening MRI Protocol

NCT04175730 | Completed Results FDA Device

• 1 other identifier: 2019-0231
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

MRI and Ultrasound

OTHER

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

Ultrasound

OTHER

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

Interventions

Ultrasound and MRI DEVICE

A single subsequent ultrasound guided prostate biopsy with MRI fusion

MRI and Ultrasound

Ultrasound DEVICE

A single subsequent ultrasound guided prostate biopsy

Ultrasound

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago Hospital and Ambulatory Clinics

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Dr. Michael Abern
• Organization: University of Illinois at Chicago

mabern1@uic.edu

312-996-9330

Study Officials

• Michael R Abern, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: November 25, 2019
• Study Start: May 20, 2019
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: June 9, 2022
• Results First Posted: June 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)