Prostate Cancer
Conditions
Keywords
Prostate Cancer
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.
Interventions
DEVICEMRI with DBSI analysis
-The procedure will take approximately 1 hour of the participant's time
Sponsors
Washington University School of Medicine
American Cancer Society, Inc.
The Foundation for Barnes-Jewish Hospital
Midwest Stone Institute.
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Masking description
-Dr. Kim will be blinded to the DBSI results at the time of biopsy, but will have the conventional MRI interpretation available
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Compare DBSI with the advanced restriction spectrum imaging (RSI) | Up to 12 weeks | The investigators will perform DBSI modeling on RSI data obtained from UCSD and the results from both DBSI and RSI protocols will be compared and analyzed to determine a strategy for improving the DBSI protocol. |
Countries
United States
Contacts
CONTACTJoseph Ippolito, M.D.
CONTACTAlex Klim
PRINCIPAL_INVESTIGATORJoseph Ippolito, M.D.
Washington University School of Medicine
Outcome results
None listed