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TrialNCT06830265

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

Status
RECRUITING
Phase
NA
Last update posted
09/04/2026
Start
07/07/2025
Sponsor
Uro-1 Medical
Specialties
family-medicine, oncology

Conditions: Prostate Cancer Screening

Brief summary

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.

Protocol documents and results are not hosted here. Verify every detail on ClinicalTrials.gov.

Clinical Evidence