MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
NCT ID: NCT05710380
Last Updated: 2025-10-01
Study Results
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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RECRUITING
NA
180 participants
INTERVENTIONAL
2023-04-26
2026-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Voluntary written informed consent before the MRI examination.
Exclusion Criteria
* 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.
18 Years
MALE
No
Sponsors
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University of Chicago
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB22-1311
Identifier Type: -
Identifier Source: org_study_id
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