Developing an Imaging-Based Tool to Identify Areas for Prostate Cancer Biopsy

NCT ID: NCT03585660

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-28
• Study Completion Date: 2023-11-06

Brief Summary

The purpose of the proposed research is to test and validate a Risk Map decision-support system (DSS) for prostate cancer Magnetic Resonance Imaging (MRI) interpretation and identification of clinically significant tumor site(s).

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Interventional Arm

Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.

Group Type: EXPERIMENTAL

Diagnostic MRI

Intervention Type: PROCEDURE

Participants will be scanned using a standard clinical prostate MRI protocol.

Diagnostic Prostate Biopsy

Intervention Type: PROCEDURE

Participants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment.

Risk Map DSS tool

Intervention Type: DEVICE

The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied.

Interventions

Diagnostic MRI

Participants will be scanned using a standard clinical prostate MRI protocol.

Intervention Type: PROCEDURE

Diagnostic Prostate Biopsy

Participants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment.

Intervention Type: PROCEDURE

Risk Map DSS tool

The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with known or suspected prostate cancer who have been referred to the Department of Radiology at the University of Chicago Medical Center for a diagnostic MRI exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate.
• Written informed consent.

Exclusion Criteria

• Patients incapable of giving informed written consent;
• Patients who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher;
• Patients with psychiatric disorders that affect their ability to consent for themselves will be excluded and not the entire population of patients with psychiatric disorders.
• Prisoners;
• Minor children (under the age of 18 years old).

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

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aytekin Oto, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago Medical Center

Chicago, Illinois, United States

Countries

United States

References

Chatterjee A, Yousuf AN, Engelmann R, Harmath C, Lee G, Medved M, Jamison EB, Lorente Campos A, Gundogdu B, Gerber G, Reynolds LF, Modi PK, Antic T, Giurcanu M, Eggener S, Karczmar GS, Oto A. Prospective Validation of an Automated Hybrid Multidimensional MRI Tool for Prostate Cancer Detection Using Targeted Biopsy: Comparison with PI-RADS-based Assessment. Radiol Imaging Cancer. 2025 Jan;7(1):e240156. doi: 10.1148/rycan.240156.

Reference Type: DERIVED

PMID: 39836080 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB17-1694

Identifier Type: -

Identifier Source: org_study_id