Diffusion Basis Spectrum Imaging of the Prostate
Conditions
Prostate CancerSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Joseph Ippolito, M.D.
- 314-362-2928
- [email protected]
Principal Investigator
- Joseph Ippolito, M.D.
Eligibility Criteria
Inclusion Criteria:
* Over 18 years of age and willing and able to provide informed consent.
* Patients with no prior diagnosis of prostate cancer, who are planning to undergo prostate biopsy as clinical standard of care ("early detection cohort")
* Including those men with:
* an elevated PSA and no prior biopsy
* an elevated PSA and a negative prior biopsy
* 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:
* Those with metallic implants, such as pacemakers or implantable cardioverter-defibrillators
* Those with cochlear implants
* Those with claustrophobia not relieved with medications (patients with claustrophobia who do not need medications for the scan or whose claustrophobia can be managed with medication, are eligible to participate)
* Those who cannot lie flat for over 1 hour
* Patients with prior prostate surgery for prostate cancer (e.g. radical prostatectomy, focal ablation)
Study Plan
Early Detection Cohort (MRI with DBSI)
EXPERIMENTAL
* Magnetic resonance imaging (MRI) with DBSI analysis prior to prostate biopsyn* Standard of care prostate biopsy will be performed within 12 weeks of MRIn* 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 analysisDescription:
-The procedure will take approximately 1 hour of the participant's time
Active Surveillance Cohort (MRI with DBSI)
EXPERIMENTAL
* Magnetic resonance imaging (MRI) with DBSI analysis prior to prostate biopsyn* Standard of care prostate biopsy will be performed within 12 weeks of MRIn* 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 analysisDescription:
-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
Receiver operating characteristic (ROC) comparison from biopsy to DBSI
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
Secondary Outcome Measures
Comparison of Gleason score from the MRI regions of interest to the DBSI predicted pathology
Area under the curve (AUC) comparison from DBSI to conventional MRI interpretation
Receiver operating characteristic (ROC) comparison from DBSI to conventional MRI interpretation
Timeline
Last Updated
July 16, 2024Start Date
June 9, 2020Today
January 22, 2025Completion Date ( Estimated )
May 31, 2027
Sponsors of this trial
Lead Sponsor
Washington University School of MedicineCollaborating Sponsors
American Cancer Society, Inc., The Foundation for Barnes-Jewish Hospital, Midwest Stone Institute., National Cancer Institute (NCI)