Developing an Imaging-Based Tool to Identify Areas for Prostate Cancer Biopsy

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Procedure: Diagnostic MRI; Procedure: Diagnostic Prostate Biopsy; Device: Risk Map DSS tool

• Registration Number: NCT03585660
• Lead Sponsor: University of Chicago

Brief Summary

The purpose of the proposed research is to test and validate a Risk Map decision-support system (DSS) for prostate cancer Magnetic Resonance Imaging (MRI) interpretation and identification of clinically significant tumor site(s).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-06-19
• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-07-11
• Study First Posted: 2018-07-13
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-25
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• Patients with known or suspected prostate cancer who have been referred to the Department of Radiology at the University of Chicago Medical Center for a diagnostic MRI exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate.
• Written informed consent.

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Exclusion Criteria

• Patients incapable of giving informed written consent;
• Patients who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher;
• Patients 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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional Arm	Risk Map DSS tool	Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.
Interventional Arm	Diagnostic MRI	Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.
Interventional Arm	Diagnostic Prostate Biopsy	Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.

Primary Outcome Measures

Name	Time	Method
Accuracy of HM-MRI	12 months	The accuracy of HM-MRI is defined as the proportion of correctly diagnosed participants for prostate cancer using HM-MRI.
Area Under the ROC Curve (AUC) of HM-MRI	12 months	In the case of a binary predictor (HM-MRI), the area under a receiver operating characteristic (ROC) curve is equivalent to the average of sensitivity and specificity. The area under an ROC curve ranges from 0 to 1.

Secondary Outcome Measures

Name	Time	Method
Sensitivity of HM-MRI	12 months	Sensitivity of HM-MRI is defined as the proportion of participants who were found positive of prostate cancer using HM-MRI among the participants who were found positive of prostate cancer using biopsy.
Specificity of HM-MRI	12 months	Specificity of HM-MRI is defined as the proportion of participants who were found negative of prostate cancer using HM-MRI among the participants who were found negative using biopsy.
Positive Predictive Value (PPV) of HM-MRI	12 months	Positive predictive value (PPV) of HM-MRI is defined as the proportion of participants who were found positive of prostate cancer using biopsy among the participants who were found positive using HM-MRI.
Negative Predictive Value (NPV) of HM-MRI	12 months	Negative predictive value (NPV) of HM-MRI is defined as the proportion of participants who were found negative of prostate cancer using biopsy among the participants who were found negative using HM-MRI.

Trial Locations

Locations (1)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States