MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy

Study Overview
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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.

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

Conditions
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Prostate Cancer, Prostate Adenocarcinoma, Prostate Neoplasm

Intervention / Treatment
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* Other: Risk Map Decision Support System (DSS).
* Radiation: Magnetic Resonance Imaging (MRI)
* Procedure: Magnetic Resonance Imaging (MRI) Guided Biopsy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Participants (Single Arm)<br>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).<br>* 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.<br>Radiation: Magnetic Resonance Imaging (MRI)<br>* A medical imaging test that uses a large machine/scanner to take images of the body and internal organs and structures.<br>Procedure: Magnetic Resonance Imaging (MRI) Guided Biopsy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer