Clinical trial · Interventional
Comparison of New SUREcore Biopsy of Needle to Standard of Care During Transperineal Prostate Biopsies
Comparison of BARD Max Core 18g Needle With Uro1 SUREcore 18g Needle in Targeted Prostate Biopsies
- 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)
To study a novel biopsy needle system for performing transperineal prostate biopsy. Prostate biopsy remains the standard approach for prostate cancer detection. While pre-biopsy MRI allows for targeting of visible lesions, systemic or 'off target' samples are recommended due to the well-recognized risk of undegrading and under sampling with current commercially available needles. The SureCore plus single-use biopsy needle produces a more intact tissue core with a same caliber 18g needle with \~21% more tissue per core in pre-clinical studies. This research study will determine if a new biopsy needle designed to produce more robust tissue cores per sample can improve detection and characterization of prostate cancer.
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 |
|---|---|---|---|
| Comparison of Biopsy Needle Types for Prostate Biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single arm study comparing two different needle biopsy systems for prostate biopsy
- interventionNames
- Diagnostic Test: Comparison of Biopsy Needle Types for Prostate Biopsy
Primary outcomes (1)
- measure
- Number of patients diagnosed with prostate cancer and histological grade of cancer detected
- timeFrame
- From prostate biopsy procedure through study completion up to 1 year
- description
- The primary outcome will evaluate whether cancer is detected on final pathological analysis. This will include the grade of cancer, percentage of core involved, and compare between the two needles.
Secondary outcomes (2)
- measure
- Quality of Biopsy Specimen Obtained at Time of Prostate Biopsy
- timeFrame
- From prostate biopsy procedure through study completion up to 1 year
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient older than age of 18 undergoing prostate biopsy Exclusion Criteria: * Unable to consent * Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives * Prisoners
References
Publications (0)
Data not yet available