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.
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
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
Single group
Novel needle biopsy catheter (test)
DeviceTissue is collected from the prostate by introducing a needle into the prostate and cutting out a sample
Atypical Small Acinar Proliferation
Presence of suspicious prostate gland cells that appear cancerous but are not definitive enough to diagnose cancer
Gleason Score
Pathologist scores the biopsy sample for the percentage of samples with a Gleason score of 7, 8, 9 or 10.
Tissue area and length
The amount of tissue retrieved by either biopsy systems-- area and length-- will be measured using computational pathology and compared
Tissue toruosity
Tortuosity will be ranked from Tier 1 (high quality) to Tier 4 (low quality) using the computational pathology algorithm.
Standard Pathology versus Computational Pathology Results
Tissue samples will be analyzed by standard pathology techniques and computational pathology and differences in values of diagnosis, Gleason score, percent tumor volume, presence of cribiform glands, and perineural invasion compared
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Uro-1 Medical
Lead sponsor
Duke University
Collaborator
NYU Langone Health
Collaborator
Novant Health, Inc.
Collaborator
