Diffusion Basis Spectrum Imaging of the Prostate: A Virtual Biopsy to Accurately Diagnose Prostate Cancer
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
United States
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Contact Information
Primary
Joseph Ippolito, M.D.
ippolitoj@wustl.edu
314-362-2925
Backup
Alex Klim
klima@wustl.edu
314-747-9781
Time Frame
Start Date: 2020-02-27
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 500
Treatments
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
Authors
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine
Collaborators: The Foundation for Barnes-Jewish Hospital, American Cancer Society, Inc., National Cancer Institute (NCI), Midwest Stone Institute.