Clinical trial · Observational
Micro-Ultrasound/Magnetic Resonance Imaging 001
Comparison of Micro-ultrasound Targeted Biopsy to mpMRI of Prostate for Detection of Clinically Significant Prostate Cancer
NCT03938376CI-TRIAL-00050990completedClinicalTrials.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)
Micro-ultrasound is a novel real-time imaging modality which maintains the clinical workflow of conventional ultrasound-guided prostate biopsy, while potentially maintaining a similar ability to detect clinically significant prostate cancer (csPCa) to MRI. This prospective trial aims to compare micro-ultrasound to mpMRI in detection of csPCa in the biopsy naïve.
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 |
|---|---|---|---|
| Diagnoses Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Micro-Ultrasound guided biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Potential Prostate Cancer
- description
- Biopsy naïve patients with rising Prostate Specific Antigen (PSA) results referred by their Urologist for a standard of care (SOC) biopsy.
- interventionNames
- Diagnostic Test: Micro-Ultrasound guided biopsy
Primary outcomes (1)
- measure
- The proportion of csPCa detected for each modality.
- timeFrame
- 1.5 years
- description
- Micro-ultrasound targeted biopsy will provide a non-inferior sensitivity to detect clinically significant prostate cancer compared to multiparametric MRI.
Secondary outcomes (1)
- measure
- The proportion of zones of PCa correctly predicted by each modality in the whole-mount pathology specimen for the subset of men selecting radical prostatectomy for treatment.
- timeFrame
- 1.5 years
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Men with indication for a prostate biopsy will be offered inclusion in the study. Indications for biopsy include clinical suspicion of prostate cancer due to elevated PSA or abnormal digital rectal exam (DRE) Exclusion Criteria: * Patients with history of prostate cancer * Patients with prior prostate biopsies * Patients who are unwilling or unable to give informed consent * Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent)
References
Publications (1)
- DERIVEDGhai S, Perlis N, Atallah C, Jokhu S, Corr K, Lajkosz K, Incze PF, Zlotta AR, Jain U, Fleming H, Finelli A, van der Kwast TH, Haider MA. Comparison of Micro-US and Multiparametric MRI for Prostate Cancer Detection in Biopsy-Naive Men. Radiology. 2022 Nov;305(2):390-398. doi: 10.1148/radiol.212163. Epub 2022 Jul 19. PMID 35852425