MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy

NCT05710380 | Recruiting DMC

• 2 other identifiers: IRB22-13115UT2CA244056
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Doctors leading this study hope to learn about a software that researchers at the University of Chicago have developed to help analyze radiographic images (different techniques for taking images that allow doctors to visualize the body's internal structures) of the prostate. Participation in this research will last about 12 months. There is a one-time MRI and 1-2 biopsies and then the investigator would like to follow the participant's progress.

Conditions

Prostate Adenocarcinoma; Prostate Neoplasm; Prostate Cancer

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (1)

• Decision Map Tool Compared to Oncologists

  Compare the accuracy of the Risk Map Decision Support Systems (DSS) tool against the clinical accuracy of experienced radiologists in the context of the reference standard of biopsy histology.

  1 year

Study Arms (1)

All Participants (Single Arm)

EXPERIMENTAL

All participants in this trial will be provided with routine instructions and precaution information before starting the magnetic resonance (MRI) scan. After the MRI, participants will undergo an MRI-guided fusion biopsy of the prostate as ordered by their doctor. During this prostate MRI-guided fusion biopsy, the research team will obtain tissue from up to two additional biopsy targets selected by the Risk Map DSS tool. Ultimately, the clinical radiologist will make the final decision on the targets to be biopsied.

Other: Risk Map Decision Support System (DSS).; Radiation: Magnetic Resonance Imaging (MRI); Procedure: Magnetic Resonance Imaging (MRI) Guided Biopsy

Interventions

Risk Map Decision Support System (DSS). OTHER

The Risk Map DSS tool is an image analysis software that automatically interprets images of the prostate that were captured using an MR (magnetic resonance) scanner (an imaging technique that uses scanners to take pictures of the body). This tool can potentially identify additional areas of cancer in your prostate that may have otherwise been missed.

All Participants (Single Arm)

Magnetic Resonance Imaging (MRI) RADIATION

A medical imaging test that uses a large machine/scanner to take images of the body and internal organs and structures.

All Participants (Single Arm)

Magnetic Resonance Imaging (MRI) Guided Biopsy PROCEDURE

A removal of tumor tissue from the body based on images of the prostate provided by a previous magnetic resonance imaging (MRI) test. Up to 2 biopsies on trial.

All Participants (Single Arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with known or suspected prostate cancer who have been referred for a diagnostic magnetic resonance imaging (MRI) exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate.
• Voluntary written informed consent before the MRI examination.

You may not qualify if:

• Subjects incapable of giving informed written consent.
• Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher;
• Subjects 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).
• Patients with previous treatments (surgery, radiation, focal ablation, hormone or other chemotherapy) for prostate cancer.

Sponsors & Collaborators

• University of Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

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)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Aytekin Oto, MD

  University of Chicago Medicine Comprehensive Cancer Center

  STUDY CHAIR

Central Study Contacts

Aytekin Oto, MD

CONTACT

773-702-8553; aoto@radiology.bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 2, 2023
• Study Start: April 26, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)