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Diagnostic Tool

Imaging-Based Biopsy Tool for Prostate Cancer

N/A
Recruiting
Led By Aytekin Oto, MD
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 12 months
Awards & highlights

Study Summary

This trial will test a new system to help doctors better interpret MRIs to find prostate cancer tumors.

Who is the study for?
This trial is for individuals with known or suspected prostate cancer who are referred for a diagnostic MRI at the University of Chicago Medical Center. They must be able to give informed consent and follow the study's procedures. It excludes minors, prisoners, those unable to consent due to psychiatric disorders, and anyone who can't communicate with researchers.Check my eligibility
What is being tested?
The study aims to validate a Risk Map decision-support system (DSS) tool designed to improve MRI interpretation in detecting clinically significant prostate cancer sites. Participants will undergo an MRI followed by an MRI-guided fusion biopsy using this new tool.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort from the MRI procedure, risks associated with biopsies such as bleeding or infection, and possible anxiety or stress related to diagnostic testing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of biopsy samples positive for prostate cancer versus those that are negative as assessed by area under the curve
Rate of biopsy samples positive for prostate cancer versus those that are negative as assessed by receiver operating characteristic curve

Trial Design

1Treatment groups
Experimental Treatment
Group I: Interventional ArmExperimental Treatment3 Interventions
Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
997 Previous Clinical Trials
817,598 Total Patients Enrolled
20 Trials studying Prostate Cancer
8,183 Patients Enrolled for Prostate Cancer
Aytekin Oto, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
229 Total Patients Enrolled
1 Trials studying Prostate Cancer
180 Patients Enrolled for Prostate Cancer

Media Library

Diagnostic MRI (Diagnostic Tool) Clinical Trial Eligibility Overview. Trial Name: NCT03585660 — N/A
Prostate Cancer Research Study Groups: Interventional Arm
Prostate Cancer Clinical Trial 2023: Diagnostic MRI Highlights & Side Effects. Trial Name: NCT03585660 — N/A
Diagnostic MRI (Diagnostic Tool) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03585660 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~17 spots leftby Jun 2025