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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am referred for a prostate MRI and biopsy at the University of Chicago Medical Center.I am under 18 years old.I am unable to give informed consent due to my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Interventional Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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