Clinical trial · Interventional
Diffusion Basis Spectrum Imaging of the Prostate
Diffusion Basis Spectrum Imaging of the Prostate: A Virtual Biopsy to Accurately Diagnose Prostate Cancer
NCT04420702CI-TRIAL-00117936recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI with DBSI analysis | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Early Detection Cohort (MRI with DBSI)
- description
- * 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
- interventionNames
- Device: MRI with DBSI analysis
- type
- EXPERIMENTAL
- label
- Active Surveillance Cohort (MRI with DBSI)
- description
- * 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
- interventionNames
- Device: MRI with DBSI analysis
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)References
Publications (0)
Data not yet available
No reference posted for this study.