An interventional study of Diagnostic MRI and Diagnostic Prostate Biopsy in Prostate Cancer, sponsored by University of Chicago. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Chicago · Not applicable, Interventional, and Diagnostic
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).
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 106 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.
Procedure: Diagnostic MRI · Procedure: Diagnostic Prostate Biopsy · Device: Risk Map DSS tool
Participants will be scanned using a standard clinical prostate MRI protocol.
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.
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.
Accuracy of HM-MRI
The accuracy of HM-MRI is defined as the proportion of correctly diagnosed participants for prostate cancer using HM-MRI.
Time frame: 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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
106 patients were enrolled in the study. Patients were recruited based on physician referral at UChicago Medical Center. The 1st patient was enrolled on August 28, 2018, and the last patient was enrolled on March 29, 2023.
| Milestone | Interventional Arm |
|---|---|
| Started | 106 |
| Completed | 91 |
| Not completed | 15 |
| Withdrew: Operator error | 1 |
| Withdrew: Technical error | 2 |
| Withdrew: Hip prosthesis | 2 |
| Withdrew: Did not undergo biopsy | 8 |
| Withdrew: Scanner problem | 2 |
The accuracy of HM-MRI is defined as the proportion of correctly diagnosed participants for prostate cancer using HM-MRI.
| proportion of participants | Interventional Arm |
|---|---|
| Accuracy of HM-MRI | 0.55 (0.45 to 0.65) |
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.
| probability | Interventional Arm |
|---|---|
| Area Under the ROC Curve (AUC) of HM-MRI | 0.63 (0.52 to 0.74) |
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.
| proportion of participants | Interventional Arm |
|---|---|
| Sensitivity of HM-MRI | 0.91 (0.81 to 1) |
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.
| proportion of participants | Interventional Arm |
|---|---|
| Specificity of HM-MRI | 0.36 (0.23 to 0.48) |
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.
| proportion of participants | Interventional Arm |
|---|---|
| Positive Predictive Value (PPV) of HM-MRI | 0.43 (0.31 to 0.55) |
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.
| proportion of participants | Interventional Arm |
|---|---|
| Negative Predictive Value (NPV) of HM-MRI | 0.88 (0.74 to 1) |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Interventional Arm | 0/106 (0%) | 0/106 (0%) | 0/106 (0%) |
| Age, Continuous(years) | Interventional Arm |
|---|---|
| Mean | 64.44 ± 7.68 |
| Sex: Female, Male(Participants) | Interventional Arm |
|---|---|
| Female | 0 |
| Male | 106 |
| Race/Ethnicity, Customized(Participants) | Interventional Arm |
|---|---|
| Asian | 4 |
| Black | 27 |
| Hispanic | 8 |
| Unknown | 4 |
| White | 63 |
| Prostate Specific Antigen (PSA)(ng/mL) | Interventional Arm |
|---|---|
| Mean | 8.81 ± 11.69 |
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University of Chicago