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

Condition(s) studied

Investigational drug(s) / intervention(s)

Novel needle biopsy catheter (test): Tissue is collected from the prostate by introducing a needle into the prostate and cutting out a sample

Study 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.

Eligibility

Primary outcome measure(s)

• Atypical Small Acinar Proliferation — From enrollment to end of treatment at 1 day
  Presence of suspicious prostate gland cells that appear cancerous but are not definitive enough to diagnose cancer
• Gleason Score — From enrollment to end of treatment at 1 day
  Pathologist scores the biopsy sample for the percentage of samples with a Gleason score of 7, 8, 9 or 10.
• Tissue area and length — From treatment to end of pathology review at 2 days
  The amount of tissue retrieved by either biopsy systems-- area and length-- will be measured using computational pathology and compared
• Tissue toruosity — From treatment to end of pathology review at 2 days
  Tortuosity will be ranked from Tier 1 (high quality) to Tier 4 (low quality) using the computational pathology algorithm.

Trial sites (3)

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