Diffusion Basis Spectrum Imaging of the Prostate
Purpose
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
- Prostate Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Male
- Accepts 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)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- 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
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
|
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 |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
More Details
- NCT ID
- NCT04420702
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine