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)