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NCT Number: NCT05710380

MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy

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.

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Adenocarcinoma Prostate Neoplasm Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Decision Map Tool Compared to Oncologists

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aytekin Oto, MD

CONTACT

[email protected]

773-702-8553

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Magnetic Resonance Imaging (MRI) Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Feb 2, 2023
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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