Prostate Cancer
Conditions
Brief 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).
Interventions
PROCEDUREDiagnostic MRI
Participants will be scanned using a standard clinical prostate MRI protocol.
PROCEDUREDiagnostic Prostate Biopsy
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.
DEVICERisk Map DSS tool
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.
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of HM-MRI | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of HM-MRI | 12 months | 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. |
| Specificity of HM-MRI | 12 months | 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. |
| Positive Predictive Value (PPV) of HM-MRI | 12 months | 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. |
| Negative Predictive Value (NPV) of HM-MRI | 12 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
112 patients were screened and 6 patients did not meet eligibility criteria of the study.
Participants by arm
| Arm | Count |
|---|---|
| Interventional Arm Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.
Diagnostic MRI: Participants will be scanned using a standard clinical prostate MRI protocol.
Diagnostic Prostate Biopsy: 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 tool: 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. | 106 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | did not undergo biopsy | 8 |
| Overall Study | hip prosthesis | 2 |
| Overall Study | operator error | 1 |
| Overall Study | scanner problem | 2 |
| Overall Study | technical error | 2 |
Baseline characteristics
| Characteristic | Interventional Arm |
|---|---|
| Age, Continuous | 64.44 years STANDARD_DEVIATION 7.68 |
| Prostate Specific Antigen (PSA) | 8.81 ng/mL STANDARD_DEVIATION 11.69 |
| Race/Ethnicity, Customized Asian | 4 Participants |
| Race/Ethnicity, Customized Black | 27 Participants |
| Race/Ethnicity, Customized Hispanic | 8 Participants |
| Race/Ethnicity, Customized Unknown | 4 Participants |
| Race/Ethnicity, Customized White | 63 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 106 |
| other Total, other adverse events | 0 / 106 |
| serious Total, serious adverse events | 0 / 106 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interventional Arm | Accuracy of HM-MRI | 0.55 proportion of participants |
Comparison: The null hypothesis is that the accuracy of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the accuracy of HM-MRI is greater than the accuracy of mp-MRI.p-value: 0.02bootstrap z-test
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Interventional Arm | Area Under the ROC Curve (AUC) of HM-MRI | 0.63 probability |
Comparison: The null hypothesis is that the AUCs of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the AUC of HM-MRI is greater than the AUC of mp-MRI.p-value: 0.08bootstrap z-test
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interventional Arm | Negative Predictive Value (NPV) of HM-MRI | 0.88 proportion of participants |
p-value: 0.97bootstrap z-test
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interventional Arm | Positive Predictive Value (PPV) of HM-MRI | 0.43 proportion of participants |
p-value: 0.06bootstrap z-test
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interventional Arm | Sensitivity of HM-MRI | 0.91 proportion of participants |
Comparison: The null hypothesis is that the sensitivity of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the sensitivity of HM-MRI is greater than the sensitivity of mp-MRI.p-value: 0.97bootstrap z-test
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interventional Arm | Specificity of HM-MRI | 0.36 proportion of participants |
Comparison: The null hypothesis is that the specificity of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the specificity of HM-MRI is greater than the specificity of mp-MRI.p-value: <0.01bootstrap z-test