Prostate CancerNCT05710380
MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
A study testing Risk Map Decision Support System (DSS)., Magnetic Resonance Imaging (MRI) and Magnetic Resonance Imaging (MRI) Guided Biopsy in people with Prostate Cancer and Prostate Adenocarcinoma, run by University of Chicago at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma, Prostate Neoplasm
- What is being tested?
- Risk Map Decision Support System (DSS)., Magnetic Resonance Imaging (MRI) and Magnetic Resonance Imaging (MRI) Guided Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Apr 2023to 1 May 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Cancer Intake Team, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Aytekin Oto
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Lauren Drake, 503-494-5157, drakela@ohsu.edu
About this study
Official title: Magnetic Resonance Imaging (MRI) Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
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.
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma, Prostate Neoplasm
- Being tested
- Risk Map Decision Support System (DSS)., Magnetic Resonance Imaging (MRI), Magnetic Resonance Imaging (MRI) Guided Biopsy
- Keywords
- prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Map Decision Support System (DSS).Other
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.
Magnetic Resonance Imaging (MRI)Radiation
A medical imaging test that uses a large machine/scanner to take images of the body and internal organs and structures.
Magnetic Resonance Imaging (MRI) Guided BiopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| All Participants (Single Arm) | Experimental | 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. Receives: Other: Risk Map Decision Support System (DSS).; Radiation: Magnetic Resonance Imaging (MRI); Procedure: Magnetic Resonance Imaging (MRI) Guided Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start26 Apr 2023
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Aytekin Oto, MD, Study chair, University of Chicago Medicine Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710380
- Sponsor's protocol ID
- IRB22-1311
- Other IDs
- 5UT2CA244056
- Status last verified
- Aug 2026
- First submitted
- 25 Jan 2023
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes