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 study identifier
interventional
200
1 country
3
Study Start
July 7, 2025
Actual (reported)Primary Completion
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 10, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 10, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 22, 2025
Actual (reported)February 17, 2025
Actual (reported)July 7, 2025
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 10, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Atypical Small Acinar Proliferation
Presence of suspicious prostate gland cells that appear cancerous but are not definitive enough to diagnose cancer
From enrollment to end of treatment at 1 day
Gleason Score
Pathologist scores the biopsy sample for the percentage of samples with a Gleason score of 7, 8, 9 or 10.
From enrollment to end of treatment at 1 day
Tissue area and length
The amount of tissue retrieved by either biopsy systems-- area and length-- will be measured using computational pathology and compared
From treatment to end of pathology review at 2 days
Tissue toruosity
Tortuosity will be ranked from Tier 1 (high quality) to Tier 4 (low quality) using the computational pathology algorithm.
From treatment to end of pathology review at 2 days
Standard Pathology versus Computational Pathology Results
From treatment to end of pathology review at 2 days
The prostate of each subject will have a tissue removed by one needle in one lobe and the other needle in the other lobe.
The prostate will be biopsied in one lobe by the control needle biopsy system and the other lobe by the test needle biopsy system.
Tissue is collected from the prostate by introducing a needle into the prostate and cutting out a sample
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
NYU Langone
New York, New York, 10016, United States
Duke University
Durham, North Carolina, 27710, United States
Thomas Lawson
Uro-1 Medical
First Submitted
January 22, 2025
First Posted
February 17, 2025
Study Start
July 7, 2025
Actual (reported)Contact the study team to confirm eligibility.
Novant Health Coastal Carolina Medical Center
Hardeeville, South Carolina, 29927, United States
Primary Completion
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 10, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 4, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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