Trial Outcomes & Findings for Developing an Imaging-Based Tool to Identify Areas for Prostate Cancer Biopsy (NCT NCT03585660)
NCT ID: NCT03585660
Last Updated: 2024-09-19
Results Overview
The accuracy of HM-MRI is defined as the proportion of correctly diagnosed participants for prostate cancer using HM-MRI.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
12 months
Results posted on
2024-09-19
Participant Flow
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.
112 patients were screened and 6 patients did not meet eligibility criteria of the study.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
106
|
|
Overall Study
COMPLETED
|
91
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
operator error
|
1
|
|
Overall Study
technical error
|
2
|
|
Overall Study
hip prosthesis
|
2
|
|
Overall Study
did not undergo biopsy
|
8
|
|
Overall Study
scanner problem
|
2
|
Baseline Characteristics
Developing an Imaging-Based Tool to Identify Areas for Prostate Cancer Biopsy
Baseline characteristics by cohort
| Measure |
Interventional Arm
n=106 Participants
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.
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|---|---|
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Age, Continuous
|
64.44 years
STANDARD_DEVIATION 7.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
63 Participants
n=5 Participants
|
|
Prostate Specific Antigen (PSA)
|
8.81 ng/mL
STANDARD_DEVIATION 11.69 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe accuracy of HM-MRI is defined as the proportion of correctly diagnosed participants for prostate cancer using HM-MRI.
Outcome measures
| Measure |
Interventional Arm
n=91 Participants
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.
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|---|---|
|
Accuracy of HM-MRI
|
0.55 proportion of participants
Interval 0.45 to 0.65
|
PRIMARY outcome
Timeframe: 12 monthsIn 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.
Outcome measures
| Measure |
Interventional Arm
n=91 Participants
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.
|
|---|---|
|
Area Under the ROC Curve (AUC) of HM-MRI
|
0.63 probability
Interval 0.52 to 0.74
|
SECONDARY outcome
Timeframe: 12 monthsSensitivity 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.
Outcome measures
| Measure |
Interventional Arm
n=91 Participants
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.
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|---|---|
|
Sensitivity of HM-MRI
|
0.91 proportion of participants
Interval 0.81 to 1.0
|
SECONDARY outcome
Timeframe: 12 monthsSpecificity 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.
Outcome measures
| Measure |
Interventional Arm
n=91 Participants
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.
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|---|---|
|
Specificity of HM-MRI
|
0.36 proportion of participants
Interval 0.23 to 0.48
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SECONDARY outcome
Timeframe: 12 monthsPositive 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.
Outcome measures
| Measure |
Interventional Arm
n=91 Participants
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.
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|---|---|
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Positive Predictive Value (PPV) of HM-MRI
|
0.43 proportion of participants
Interval 0.31 to 0.55
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SECONDARY outcome
Timeframe: 12 monthsNegative 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.
Outcome measures
| Measure |
Interventional Arm
n=91 Participants
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.
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|---|---|
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Negative Predictive Value (NPV) of HM-MRI
|
0.88 proportion of participants
Interval 0.74 to 1.0
|
Adverse Events
Interventional Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Aytekin Oto, MD, MBA
Department of Radiology, University of Chicago
Phone: 1-773-702-8553
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60