N/A
N=106
Developing an Imaging-Based Tool to Identify Areas for Prostate Cancer Biopsy
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03585660 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Accuracy of HM-MRI — 0.55 proportion of participants — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Diagnostic MRI (Procedure); Diagnostic Prostate Biopsy (Procedure); Risk Map DSS tool (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Chicago
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of HM-MRI |
0.55 | 0.02 sig |
| PRIMARY Area Under the ROC Curve (AUC) of HM-MRI |
0.63 | 0.08 |
| SECONDARY Sensitivity of HM-MRI |
0.91 | 0.97 |
| SECONDARY Specificity of HM-MRI |
0.36 | <0.01 sig |
| SECONDARY Positive Predictive Value (PPV) of HM-MRI |
0.43 | 0.06 |
| SECONDARY Negative Predictive Value (NPV) of HM-MRI |
0.88 | 0.97 |
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).
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT03585660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.