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NCT Number: NCT06830265

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

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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Key information

Conditions

Prostate Cancer Screening

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

Prostate tissue captured in needle biopsy procedures are used to diagnose prostate cancer, but current biopsy systems (standard of care control device) have been shown to underperform when compared to a new novel needle biopsy system (test device). The objectives of the study are to (1) compare tissue quality between test and control devices; (2) compare diagnostic ambiguity between the two devices; and (3) compare tissue area, length, and tortuosity from the samples with a computational pathology algorithm. Tissue analyses will be completed by pathologists blinded to the biopsy system used.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novel needle biopsy catheter (test)

Device

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

Primary outcomes

  1. Atypical Small Acinar Proliferation

    Time frame: 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

  2. Gleason Score

    Time frame: 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.

  3. Tissue area and length

    Time frame: 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

  4. Tissue toruosity

    Time frame: 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.

Secondary outcomes

  1. Standard Pathology versus Computational Pathology Results

    Time frame: From treatment to end of pathology review at 2 days

    Tissue samples will be analyzed by standard pathology techniques and computational pathology and differences in values of diagnosis, Gleason score, percent tumor volume, presence of cribiform glands, and perineural invasion compared

Study contacts

Contact information is provided by the study sponsor or research team.

Ted Belleaza

CONTACT

[email protected]

831-295-7133

Thomas Lawson, PHD

CONTACT

[email protected]

510-206-1794

Sponsors and collaborators

Lead sponsor

Uro-1 Medical

Industry

Collaborators

  • Duke University
  • NYU Langone Health

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 17, 2025
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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