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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.
Who can join
Ages 18 and older · Men
Full eligibility criteria
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
About the study
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.
What is being tested
- Novel needle biopsy catheter (test) (device)
Sponsor: Uro-1 Medical · Participants: 200 · Started: Jul 7, 2025
Contact the study team
- Thomas Lawson, PhD · Phone: 510-206-1794
- Ted Belleza, BA · Phone: 831-295-7133
Official record on ClinicalTrials.gov — NCT06830265
Locations in the U.S.
| North Carolina | Duke University, Durham |
| South Carolina | Novant Health Coastal Carolina Medical Center, Hardeeville |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.