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Procedure
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
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
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,062 Previous Clinical Trials
839,956 Total Patients Enrolled
23 Trials studying Prostate Cancer
11,217 Patients Enrolled for Prostate Cancer
Aytekin Oto, MDStudy ChairUniversity of Chicago Medicine Comprehensive Cancer Center
2 Previous Clinical Trials
155 Total Patients Enrolled
1 Trials studying Prostate Cancer
106 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to understand or sign the consent form.I am under 18 years old.I have had treatments like surgery or chemotherapy for prostate cancer.I am referred for a prostate MRI and biopsy due to suspected prostate cancer.
Research Study Groups:
This trial has the following groups:- Group 1: All Participants (Single 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.