Status:
RECRUITING
Diffusion Basis Spectrum Imaging of the Prostate
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
American Cancer Society, Inc.
The Foundation for Barnes-Jewish Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 c...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04420702
Start Date
February 27 2020
End Date
May 31 2027
Last Update
July 18 2025
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110