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

RecruitingNAAges 18 Years - anyMaleUro-1 Medical
NCT06830265 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Novel needle biopsy catheter (test)
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Where

3 sites
NYU Langone
New York, United States
Duke University
Durham, United States
Novant Health Coastal Carolina Medical Center
Hardeeville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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