Comparing Standard of Care Biopsy System to a Novel Biopsy Needle System by Computational Pathologic Analysis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUro-1 Medical

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Novel needle biopsy catheter (test)

Treatment groups

20 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Uro-1 Medical

Lead sponsor

Duke University

Collaborator

NYU Langone Health

Collaborator