MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy

The University of Chicago

Status: Enrolling

Conditions: Prostate Neoplasm; Prostate Adenocarcinoma; Prostate Cancer

Treatments: Procedure: Magnetic Resonance Imaging (MRI) Guided Biopsy; Other: Risk Map Decision Support System (DSS).; Radiation: Magnetic Resonance Imaging (MRI)

Study type: Interventional

Funder types: Other

Identifiers

NCT05710380

IRB22-1311

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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180 participants in 1 patient group

All Participants (Single Arm)

Experimental group

Description:

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.

Treatment:

Radiation: Magnetic Resonance Imaging (MRI)

Other: Risk Map Decision Support System (DSS).

Procedure: Magnetic Resonance Imaging (MRI) Guided Biopsy