Clinical trial · Interventional
Urology San Antonio MRI/MicroUS Comparison
NCT03762616CI-TRIAL-00051373completedN/AResults postedClinicalTrials.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)
This study compares micro-ultrasound image targeted prostate biopsy with multi-parametric MRI targeted biopsy in men indicated for prostate biopsy due to suspicion of prostate cancer. Both imaging techniques will be applied to each subject and compared, along with systematic biopsy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Micro-ultrasound targeted biopsy | Diagnostic Test | — | UNRESOLVED |
| mpMRI targeted biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Micro-Ultrasound Biopsy
- interventionNames
- Diagnostic Test: Micro-ultrasound targeted biopsy
- type
- EXPERIMENTAL
- label
- MRI Targeted Biopsy
- interventionNames
- Diagnostic Test: mpMRI targeted biopsy
Primary outcomes (1)
- measure
- Number of Participants With Clinically Significant Cancer
- timeFrame
- At time of biopsy
- description
- Comparison of subject-level detection rate of clinically significant cancer (csPCa, defined as Grade Group 2 or higher) between micro-ultrasound targeted biopsy and mpMRI targeted biopsy.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men presenting for prostate biopsy due to clinical suspicion of prostate cancer 2. 40-75 years old 3. Available mpMRI images and report, performed according to the PI-RADS v2 standard Exclusion Criteria: 1. Men with anorectal abnormalities preventing TRUS-guided prostate biopsy 2. Men who are unable to provide their own informed consent 3. Prostate volume on MRI \> 100cc
References
Publications (0)
Data not yet available
No reference posted for this study.