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
- Are there results?
- Not yet: the study is under way
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.
United States2 sites
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Oregon Health & Science University
Portland, Oregon, 97239
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 completionJul 2027 (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
- Oct 2026
- First submitted
- 25 Jan 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging (MRI) Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
- ClinicalTrials.gov ID
- NCT05710380
- Acronym / sponsor ID
- IRB22-1311
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma, Prostate Neoplasm
- Keywords
- prostate cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants (Single Arm) | Experimental | Other: Risk Map Decision Support System (DSS)., Radiation: Magnetic Resonance Imaging (MRI), Procedure: Magnetic Resonance Imaging (MRI) Guided BiopsyAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk Map Decision Support System (DSS).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. | Other | All Participants (Single Arm) |
| Magnetic Resonance Imaging (MRI)A medical imaging test that uses a large machine/scanner to take images of the body and internal organs and structures. | Radiation | All Participants (Single Arm) |
| Magnetic Resonance Imaging (MRI) Guided BiopsyA 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. | Procedure or surgery | All Participants (Single Arm) |
Primary outcome
Decision Map Tool Compared to Oncologists
Time frame: 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aytekin Oto, MD study chair
University of Chicago Medicine Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision Map Tool Compared to Oncologists (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.