Diffusion Basis Spectrum Imaging of the Prostate
Study Details
Study Description
Brief Summary
Diffusion Basis Spectrum Imaging (DBSI) represents a potential leap forward in improving prostate cancer early detection: a non-invasive and accurate imaging test for clinically significant prostate cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Early Detection Cohort (MRI with DBSI) Magnetic resonance imaging (MRI) with DBSI analysis prior to prostate biopsy Standard of care prostate biopsy will be performed within 12 weeks of MRI Some participants may go on to receive standard of care radical prostatectomy and those participants may have their prostatectomy specimens scanned via MRI with DBSI imaging |
Device: MRI with DBSI analysis
-The procedure will take approximately 1 hour of the participant's time
|
| Experimental: Active Surveillance Cohort (MRI with DBSI) Magnetic resonance imaging (MRI) with DBSI analysis prior to prostate biopsy Standard of care prostate biopsy will be performed within 12 weeks of MRI Some participants may go on to receive standard of care radical prostatectomy and those participants may have their prostatectomy specimens scanned via MRI with DBSI imaging |
Device: MRI with DBSI analysis
-The procedure will take approximately 1 hour of the participant's time
|
Outcome Measures
Primary Outcome Measures
- Area under the curve (AUC) comparison from biopsy and DBSI [Up to 12 weeks]
As a per patient analysis, the investigators will use the highest Gleason score from the biopsy as the reference standard In the per patient analysis, Gleason 7 or greater, will be the cut-off as this will be considered "clinically significant". The investigators will also perform similar analyses with cut-offs of Gleason 4+3=7 or greater, as well as Gleason 6 or greater. This will serve as the sensitivity analysis.
- Receiver operating characteristic (ROC) comparison from biopsy to DBSI [Up to 12 weeks]
As a per patient analysis, the investigators will use the highest Gleason score from the biopsy as the reference standard In the per patient analysis, Gleason 7 or greater, will be the cut-off as this will be considered "clinically significant". The investigators will also perform similar analyses with cut-offs of Gleason 4+3=7 or greater, as well as Gleason 6 or greater. This will serve as the sensitivity analysis.
- Prostate sector analysis as measured by comparison of the highest Gleason score from each of the 10 biopsy sectors to the DBSI predicted pathology from each sector [Up to 12 weeks]
Secondary Outcome Measures
- Comparison of Gleason score from the MRI regions of interest to the DBSI predicted pathology [Up to 12 weeks]
-Only for those patients with a suspicious MRI lesion
- Area under the curve (AUC) comparison from DBSI to conventional MRI interpretation [Up to 12 weeks]
- Receiver operating characteristic (ROC) comparison from DBSI to conventional MRI interpretation [Up to 12 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Over 18 years of age and willing and able to provide informed consent.
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Patients with no prior diagnosis of prostate cancer, who are planning to undergo prostate biopsy as clinical standard of care ("early detection cohort")
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Including those men with:
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an elevated PSA and no prior biopsy
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an elevated PSA and a negative prior biopsy
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Patients with a prior diagnosis of prostate cancer, who are currently managed with active surveillance, who are planning to undergo biopsy as clinical standard of care ("active surveillance cohort")
Exclusion Criteria:
- Patients with any clinical contraindication to MRI
*Including but not limited to:
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Those with metallic implants, such as pacemakers or implantable cardioverter-defibrillators
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Those with cochlear implants
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Those with claustrophobia
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Those who cannot lie flat for over 1 hour
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Patients with prior prostate surgery (e.g. radical prostatectomy, TURP)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
- American Cancer Society, Inc.
- The Foundation for Barnes-Jewish Hospital
- Midwest Stone Institute.
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Eric Kim, M.D., Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 201908215
- R01CA258690