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Prostate Cancer ScreeningDiagnostics and screeningProstate healthMen's healthDevice

What this study is

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's being tested

  • Novel needle biopsy catheter (test)

    Intervention · DEVICE

    Tissue is collected from the prostate by introducing a needle into the prostate and cutting out a sample

Study details

Official title
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.
Sponsor
Uro-1 Medical
Conditions
Prostate Cancer Screening
Enrolling
200 people
Starts
2025-07-07
Est. completion
2026-12-10
Design
Single-blind, non-randomized, single group
Record
View on ClinicalTrials.gov ↗