Clinical trial · Observational
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy for the Detection of Clinically Significant Prostate Cancer
NCT05471128CI-TRIAL-00122457OU-SCC-PROBXactive not recruitingClinicalTrials.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)
The purpose of this study is to find out how best to detect clinically significant lesions of prostate cancer by using micro-ultrasound technology (ExactVu) and by multiparametric magnetic-resonance imaging (mpMRI).
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 |
|---|---|---|---|
| Standard of Care Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Detection Rate
- timeFrame
- 2 years
- description
- To compare the detection rates of clinically significant prostate cancer lesions by ExactVu micro-ultrasound and by MRI-fusion
- measure
- Feasibility of ExactVu
- timeFrame
- 2 years
- description
- To determine the feasibility of using ExactVu micro-ultrasounds to screen for prostate cancer in socioeconomically disadvantaged populations with limited access to care. Feasibility is measured by the percentage of patients that successfully undergo the study procedures.
Secondary outcomes (2)
- measure
- Predictive Performance Measures
- timeFrame
- 2 years
- description
- To evaluate the sensitivity of ExactVu micro-ultrasound method and MRI-fusion method in detection of prostate cancer
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients scheduled to undergo biopsy and with one of the following: * Men with suspicion of prostate cancer * Men on active surveillance 2. Age ≥18 \[30\] 3. Have available multiparametric prostate MRI 4. Able to provide written, informed consent 5. No significant medical illness which in the opinion of the Investigator would preclude entry to study procedures 6. Be willing and able to comply with scheduled visits Exclusion Criteria: 1. Previously confirmed prostate cancer diagnosis with Grade Group \>= 2 2. Unable to undergo prostate biopsy 3. Prostate MRI unable to be evaluated using the PI-RADS v2 criteria 4. Men with contraindication for MRI or a prostate biopsy 5. Prostate biopsy within 8 weeks prior to mpMRI. 6. Any history of prostate treatment
References
Publications (0)
Data not yet available
No reference posted for this study.