Clinical trial · Observational
Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy
Improved Detection and Localization Accuracy of Early Aggressive Prostate Adenocarcinoma Using Novel MR-directed Ultrasound-guided (MRdUSg) Prostate Biopsy Technique
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Per PI, the project start is on suspension.
Summary
Brief summary (as posted)
The purpose of this study is to utilize this technology in the early detection and staging of pathologic states within prostate cancer patients using the information obtained on mpMRI and serum biomarkers from the patient's blood (if collected). Ultimately, investigators hope to improve the diagnostic accuracy and treatment selection process for these patients. Applying the fusion software which adds mpMRI to ultrasound images in real time, to an otherwise clinically standard but non-targeted ultrasound-guided prostate biopsy procedure will help with accurate and early diagnosis of prostate cancer.
Conditions
Conditions (2)
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 Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TRUS biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- All subjects
- description
- The experimental conditions will include a standard prostate biopsy using an FDA-approved ultrasound machine with application of the experimental (non-FDA approved) image fusion software.
- interventionNames
- Diagnostic Test: TRUS biopsy
Primary outcomes (1)
- measure
- Evaluate investigational fusion software.
- timeFrame
- Through study completion, planned 5 year duration.
- description
- To evaluate the sensitivity of the investigational software to aid in targeted biopsy of prostate lesions seen on pre-biopsy mpMRI.
Secondary outcomes (3)
- measure
- Assess accuracy of mpMRI.
- timeFrame
- Through study completion, planned 5 year duration.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Able to give informed consent 2. Male - age \> 18 3. mpMRI within the previous 6 months (PIRADS 3,4,5, all stages of PCa) 4. Scheduled for TRUS biopsy for prostate lesion or mass Exclusion Criteria: 1. Age under 18 years of age. 2. Female 3. Pre-existing blood dyscrasias 4. Inability to perform TRUS due to anal sphincter closure/surgery 5. Patients needing general anesthesia 6. Patients allergic to lidocaine 7. Patients allergic or unable to take antibiotics
References
Publications (0)
Data not yet available