Recruiting

Prostate Cancer

Sponsor:

University of Chicago

Code:

NCT05710380

Conditions

Prostate Cancer

Prostate Adenocarcinoma

Prostate Neoplasm

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Risk Map Decision Support System (DSS).

Magnetic Resonance Imaging (MRI)

Magnetic Resonance Imaging (MRI) Guided Biopsy

Study Details

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 Cancer

Prostate Adenocarcinoma

Prostate Neoplasm

Study ID

NCT05710380

Start date

Apr 26, 2023

Status verified date

Aug, 2026

Completion date

May 1, 2029

Anticipated

Primary completion date

May 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

180 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

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.

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.

Primary outcome measure

  • Decision Map Tool Compared to Oncologists [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Aytekin Oto, MD

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

Locations

University of Chicago Medicine Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Cancer Intake Team

855-702-8222cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator:

Aytekin Oto

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Lauren Drake

503-494-5157drakela@ohsu.edu

More Information

Sponsor

University of Chicago

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • prostate cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-09-01.