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

The University of Chicago

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: Diagnostic Prostate Biopsy; Device: Risk Map DSS tool; Procedure: Diagnostic MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT03585660

IRB17-1694

Details and patient eligibility

About

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).

Enrollment: 106 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 1 patient group

Interventional Arm

Experimental group

Description:

Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.

Treatment:

Procedure: Diagnostic MRI

Device: Risk Map DSS tool

Procedure: Diagnostic Prostate Biopsy