Prostate CancerNCT03585660
Developing an Imaging-Based Tool to Identify Areas for Prostate Cancer Biopsy
A study testing Diagnostic MRI, Diagnostic Prostate Biopsy and Risk Map DSS tool in people with Prostate Cancer, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of the proposed research is to test and validate a Risk Map decision-support system (DSS) for prostate cancer Magnetic Resonance Imaging (MRI) interpretation and identification of clinically significant tumor site(s). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Diagnostic MRI, Diagnostic Prostate Biopsy and Risk Map DSS tool
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2018to 6 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to the Department of Radiology at the University of Chicago Medical Center for a diagnostic MRI exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate.
- Written informed consent.
Who cannot join
- Patients incapable of giving informed written consent;
- Patients who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher;
- Patients 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: MRI Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
The purpose of the proposed research is to test and validate a Risk Map decision-support system (DSS) for prostate cancer Magnetic Resonance Imaging (MRI) interpretation and identification of clinically significant tumor site(s).
- Conditions
- Prostate Cancer
- Being tested
- Diagnostic MRI, Diagnostic Prostate Biopsy, Risk Map DSS tool
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic MRIProcedure or surgery
Participants will be scanned using a standard clinical prostate MRI protocol.
Diagnostic Prostate BiopsyProcedure or surgery
Participants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment.
Risk Map DSS toolDevice
The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors. Receives: Procedure: Diagnostic MRI; Procedure: Diagnostic Prostate Biopsy; Device: Risk Map DSS tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of HM-MRI
The accuracy of HM-MRI is defined as the proportion of correctly diagnosed participants for prostate cancer using HM-MRI.
Measured: 12 months
Area Under the ROC Curve (AUC) of HM-MRI
In the case of a binary predictor (HM-MRI), the area under a receiver operating characteristic (ROC) curve is equivalent to the average of sensitivity and specificity. The area under an ROC curve ranges from 0 to 1.
Measured: 12 months
Secondary outcomes (4)
Sensitivity of HM-MRI
Sensitivity of HM-MRI is defined as the proportion of participants who were found positive of prostate cancer using HM-MRI among the participants who were found positive of prostate cancer using biopsy.
Measured: 12 months
Specificity of HM-MRI
Specificity of HM-MRI is defined as the proportion of participants who were found negative of prostate cancer using HM-MRI among the participants who were found negative using biopsy.
Measured: 12 months
Positive Predictive Value (PPV) of HM-MRI
Positive predictive value (PPV) of HM-MRI is defined as the proportion of participants who were found positive of prostate cancer using biopsy among the participants who were found positive using HM-MRI.
Measured: 12 months
Negative Predictive Value (NPV) of HM-MRI
Negative predictive value (NPV) of HM-MRI is defined as the proportion of participants who were found negative of prostate cancer using biopsy among the participants who were found negative using HM-MRI.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start28 Aug 2018
- Primary completion9 Jun 2023
- Study completion6 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aytekin Oto, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585660
- Sponsor's protocol ID
- IRB17-1694
- Status last verified
- May 2024
- First submitted
- 19 Jun 2018
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Chatterjee A, Yousuf AN, Engelmann R, Harmath C, Lee G, Medved M, Jamison EB, Lorente Campos A, Gundogdu B, Gerber G, Reynolds LF, Modi PK, Antic T, Giurcanu M, Eggener S, Karczmar GS, Oto A. Prospective Validation of an Automated Hybrid Multidimensional MRI Tool for Prostate Cancer Detection Using Targeted Biopsy: Comparison with PI-RADS-based Assessment. Radiol Imaging Cancer. 2025 Jan;7(1):e240156. doi: 10.1148/rycan.240156.
PubMed 39836080
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
- ClinicalTrials.gov ID
- NCT03585660
- Acronym / sponsor ID
- IRB17-1694
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 6 Nov 2023 (actual)
- First posted
- 13 Jul 2018 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the proposed research is to test and validate a Risk Map decision-support system (DSS) for prostate cancer Magnetic Resonance Imaging (MRI) interpretation and identification of clinically significant tumor site(s).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Procedure: Diagnostic MRI, Procedure: Diagnostic Prostate Biopsy, Device: Risk Map DSS toolParticipants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors. |
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 to the Department of Radiology at the University of Chicago Medical Center for a diagnostic MRI exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate.
- Written informed consent.
Key exclusion criteria (5 listed)
- Patients incapable of giving informed written consent;
- Patients who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher;
- Patients 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 |
|---|---|---|
| Diagnostic MRIParticipants will be scanned using a standard clinical prostate MRI protocol. | Procedure or surgery | Interventional Arm |
| Diagnostic Prostate BiopsyParticipants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment. | Procedure or surgery | Interventional Arm |
| Risk Map DSS toolThe Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied. | Device | Interventional Arm |
Primary outcome
Accuracy of HM-MRI
Time frame: 12 months
The accuracy of HM-MRI is defined as the proportion of correctly diagnosed participants for prostate cancer using HM-MRI.
Area Under the ROC Curve (AUC) of HM-MRI
Time frame: 12 months
In the case of a binary predictor (HM-MRI), the area under a receiver operating characteristic (ROC) curve is equivalent to the average of sensitivity and specificity. The area under an ROC curve ranges from 0 to 1.
4 secondary outcomes
Sensitivity of HM-MRI
Time frame: 12 months
Specificity of HM-MRI
Time frame: 12 months
Positive Predictive Value (PPV) of HM-MRI
Time frame: 12 months
Negative Predictive Value (NPV) of HM-MRI
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39836080Chatterjee A, Yousuf AN, Engelmann R, Harmath C, Lee G, Medved M, Jamison EB, Lorente Campos A, Gundogdu B, Gerber G, Reynolds LF, Modi PK, Antic T, Giurcanu M, Eggener S, Karczmar GS, Oto A. Prospective Validation of an Automated Hybrid Multidimensional MRI Tool for Prostate Cancer Detection Using Targeted Biopsy: Comparison with PI-RADS-based Assessment. Radiol Imaging Cancer. 2025 Jan;7(1):e240156. doi: 10.1148/rycan.240156.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic MRI, Diagnostic Prostate Biopsy and Risk Map DSS tool in people with Prostate Cancer, run by University of Chicago at 1 site 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 5 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Accuracy of HM-MRI (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03585660, which also lists 1 linked publication.
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 19 Sep 2024.