Clinical trial · Interventional
Comparing Standard of Care Biopsy System to a Novel Biopsy Needle System by Computational Pathologic Analysis
Comparing a Standard of Care Prostate Biopsy System With a Novel System Using Standard as Well as Computational Pathology Analyses to Measure Clinical and Morphometric Parameters.
- 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)
Prostate biopsy is the definitive examination to establish the diagnosis of prostate cancer, but up to 40% of these biopsies overestimate or underestimate the severity of the disease. A novel biopsy needle system captures substantially more tissue than standard of care needles, but it is important to assess the retrieval of tissue for pathologic analyses. This study will compare quality and quantity of tissue retrieved by both systems. Further, tissue will be analyzed using computational pathology algorithms for atypical small acinar proliferation and Gleason scores in terms of tissue area, tissue length, and tissue tortuosity.
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 Screening | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Novel needle biopsy catheter (test) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Test group
- description
- The prostate of each subject will have a tissue removed by one needle in one lobe and the other needle in the other lobe.
- interventionNames
- Device: Novel needle biopsy catheter (test)
- type
- ACTIVE_COMPARATOR
- label
- Single Arm
- description
- The prostate will be biopsied in one lobe by the control needle biopsy system and the other lobe by the test needle biopsy system.
- interventionNames
- Device: Novel needle biopsy catheter (test)
Primary outcomes (4)
- measure
- Atypical Small Acinar Proliferation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult males with PSA density greater than or equal to 0.15 * Lesions are visible under MRI * PIRADS score is greater than or equal to 3 * Able to and willing to provide consent Exclusion Criteria: * Subject has had previous local prostate therapy, focal therapy, brachytherapy, ADT, surgery, or chemotherapy for prostate cancer * History of dementia, cognitive impairment, or deep vein thrombosis (DVT) * Is a prisoner currently or has a history of incarceration * Unable to understand English * Has metastatic prostate cancer or a tumor stage of T2c, T3, or T4 * Has concurrent malignancies * Is positive for HIV, HBV, and/or HCV infection * Has low-performance status
References
Publications (0)
Data not yet available