Clinical trial · Interventional
SmartTarget: BIOPSY
SmartTarget - A Magnetic Resonance Image to Ultrasound Fusion System for Targeted Prostate Intervention: Biopsy
- 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 determine how well SmartTarget guided prostate biopsies perform, compared with our current standard of "visually directed biopsies" in the detection of prostate cancer. The diagnosis of prostate cancer is dependent upon sampling the prostate to confirm disease. Standard trans-rectal biopsies are taken in a random fashion, without prior knowledge of the disease location. Transperineal mapping biopsies overcome this by systematically samples the entire gland but are very intensive and time consuming to perform. An alternative method is to perform targeted prostate biopsies where an MRI prior to biopsy can be used to inform doctors about the location of the disease. This is a difficult procedure to perform as it requires the surgeon to mentally translate the location of disease on MRI image to the live ultrasound seen in theatre. SmartTarget may help this procedure by providing guidance to the location of the disease by fusing the MRI image onto the live ultrasound, thereby providing the clinician a target to biopsy. This trial will compare the outcomes of "visually directed biopsies" with those directed by SmartTarget
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 |
|---|---|---|---|
| Diagnostic Techniques and Procedures | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SmartTarget - Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Biopsy
- description
- Single Arm Study. Biopsy Intervention.
- interventionNames
- Procedure: SmartTarget - Biopsy
Primary outcomes (1)
- measure
- Cancer Detection
- timeFrame
- Within 3 weeks of biopsy
- description
- The proportion of men with clinically significant disease based on SmartTarget guided biopsy compared to the proportion of men with clinically significant disease based on visually-directed biopsy.
Secondary outcomes (3)
- measure
- Targeting Efficiency (core length, grade)
- timeFrame
- Within 3 weeks of Biopsy
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Previous TRUS biopsy with clinical indication for repeat biopsy * Discrete lesion on mpMRI scoring 3, 4 or 5 on PI-RADs scale * An understanding of the English language sufficient to understand written and verbal information about the trial and consent process * Signed informed consent Exclusion Criteria: * Men who have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months * Men with an irreversible coagulopathy predisposing to bleeding * Men who are unability to undergo transrectal ultrasonography * Men who have had previous radiation therapy to the pelvis * Men who have had HIFU, cryosurgery, thermal, irreversible electroporation, photodynamic, photothermal therapy, or microwave therapy to the prostate. Transurethral resection or vaporization of the prostate for benign prostatic hyperplasia using any energy modality is permitted * Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging * Men who are unable to give informed consent
References
Publications (0)
Data not yet available