Recruiting NCT04420702
Diffusion Basis Spectrum Imaging of the Prostate
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI with DBSI analysis.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Diffusion Basis Spectrum Imaging of the Prostate: A Virtual Biopsy to Accurately Diagnose Prostate Cancer
Overview
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
- Device MRI with DBSI analysis
-The procedure will take approximately 1 hour of the participant's time
Primary outcome measures
- Area under the curve (AUC) comparison from biopsy and DBSI [Time frame: Up to 12 weeks]
- Receiver operating characteristic (ROC) comparison from biopsy to DBSI [Time frame: Up to 12 weeks]
- 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 [Time frame: Up to 12 weeks]
Secondary outcome measures (4)
- Comparison of Gleason score from the MRI regions of interest to the DBSI predicted pathology [Time frame: Up to 12 weeks]
- Area under the curve (AUC) comparison from DBSI to conventional MRI interpretation [Time frame: Up to 12 weeks]
- Receiver operating characteristic (ROC) comparison from DBSI to conventional MRI interpretation [Time frame: Up to 12 weeks]
- Compare DBSI with the advanced restriction spectrum imaging (RSI) [Time frame: Up to 12 weeks]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Washington University School of Medicine — St Louis
Identifiers
NCT: NCT04420702 · 201908215 · R01CA258690