MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy

NCT ID: NCT05710380

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-26

Study Completion Date

2026-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer Prostate Adenocarcinoma Prostate Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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All Participants (Single Arm)

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.

Group Type EXPERIMENTAL

Risk Map Decision Support System (DSS).

Intervention Type 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.

Magnetic Resonance Imaging (MRI)

Intervention Type RADIATION

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

Magnetic Resonance Imaging (MRI) Guided Biopsy

Intervention Type 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.

Interventions

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Risk Map Decision Support System (DSS).

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.

Intervention Type OTHER

Magnetic Resonance Imaging (MRI)

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

Intervention Type RADIATION

Magnetic Resonance Imaging (MRI) Guided Biopsy

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aytekin Oto, MD

Role: STUDY_CHAIR

University of Chicago Medicine Comprehensive Cancer Center

Locations

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University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Aytekin Oto, MD

Role: CONTACT

773-702-8553

Facility Contacts

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Cancer Intake Team

Role: primary

855-702-8222

Other Identifiers

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IRB22-1311

Identifier Type: -

Identifier Source: org_study_id

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