MRI Risk Maps for Prostate Cancer Diagnosis

N/A

Recruiting

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at a software to analyze prostate images. Involves 1-2 biopsies, 1 MRI. Follow-up over 12 months.

Who is the study for?

This trial is for men who are suspected to have prostate cancer or already diagnosed and referred for an MRI of the prostate. They must be able to give written consent and follow study procedures. It's not open to those under 18, prisoners, anyone previously treated for prostate cancer, or with psychiatric disorders affecting consent.

What is being tested?

Researchers are testing a new software tool designed to improve the analysis of MRI images of the prostate. The goal is to see if this Risk Map Decision Support System can help diagnose prostate cancer more accurately using targeted biopsy guided by MRI.

What are the potential side effects?

Potential side effects may include discomfort from the MRI procedure, risks associated with biopsies like infection or bleeding, and possible anxiety related to undergoing diagnostic tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Decision Map Tool Compared to Oncologists

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: All Participants (Single Arm)Experimental Treatment3 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging (MRI)

2015

Completed Phase 4

~1800

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