Back to resultsMRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
Primary Purpose
Prostate Cancer, Prostate Adenocarcinoma, Prostate Neoplasm
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Risk Map Decision Support System (DSS).
Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI) Guided Biopsy
Sponsored by
About this trial
This is an interventional screening trial for Prostate Cancer focused on measuring prostate cancer
Eligibility Criteria
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.
Sites / Locations
- University of Chicago Medicine Comprehensive Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All Participants (Single Arm)
Arm 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.
Outcomes
Primary Outcome Measures
Decision Map Tool Compared to Oncologists
Compare the accuracy of the Risk Map Decision Support Systems (DSS) tool against the clinical accuracy of experienced radiologists in the context of the reference standard of biopsy histology.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05710380
Brief Title
MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
Official Title
Magnetic Resonance Imaging (MRI) Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
May 1, 2026 (Anticipated)
Study Completion Date
May 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Adenocarcinoma, Prostate Neoplasm
Keywords
prostate cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All Participants (Single Arm)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Risk Map Decision Support System (DSS).
Intervention Description
The Risk Map DSS tool is an image analysis software that automatically interprets images of the prostate that were captured using an MR (magnetic resonance) scanner (an imaging technique that uses scanners to take pictures of the body). This tool can potentially identify additional areas of cancer in your prostate that may have otherwise been missed.
Intervention Type
Radiation
Intervention Name(s)
Magnetic Resonance Imaging (MRI)
Intervention Description
A medical imaging test that uses a large machine/scanner to take images of the body and internal organs and structures.
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging (MRI) Guided Biopsy
Intervention Description
A removal of tumor tissue from the body based on images of the prostate provided by a previous magnetic resonance imaging (MRI) test. Up to 2 biopsies on trial.
Primary Outcome Measure Information:
Title
Decision Map Tool Compared to Oncologists
Description
Compare the accuracy of the Risk Map Decision Support Systems (DSS) tool against the clinical accuracy of experienced radiologists in the context of the reference standard of biopsy histology.
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aytekin Oto, MD
Phone
773-702-8553
Email
aoto@radiology.bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aytekin Oto, MD
Organizational Affiliation
University of Chicago Medicine Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Chicago Medicine Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cancer Intake Team
Phone
855-702-8222
Email
cancerclinicaltrials@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Aytekin Oto
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
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