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

NCT06830265 | Not Yet Recruiting FDA Device

• 1 other identifier: 25-001
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer Screening

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Standard Pathology versus Computational Pathology Results

  From treatment to end of pathology review at 2 days

Study Arms (2)

Test group

ACTIVE COMPARATOR

The prostate of each subject will have a tissue removed by one needle in one lobe and the other needle in the other lobe.

Device: Novel needle biopsy catheter (test)

Single Arm

ACTIVE COMPARATOR

The prostate will be biopsied in one lobe by the control needle biopsy system and the other lobe by the test needle biopsy system.

Device: Novel needle biopsy catheter (test)

Interventions

Novel needle biopsy catheter (test) DEVICE

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

Single Arm; Test group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males, since only males have a prostate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uro-1 Medical: lead
• Duke University: collaborator
• NYU Langone Health: collaborator

Study Officials

• Ted Belleza

  Uro-1 Medical

  STUDY DIRECTOR

Central Study Contacts

Ted Belleaza

CONTACT

831-295-7133; tbelleza@uro1medical.com

Thomas Lawson, PHD

CONTACT

510-206-1794; drthomlawson@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each patient enrolled will have prostate biopsy completed with a standard of care needle biopsy system (control) and a novel needle biopsy system (test), each targeting separate regions of the prostate.

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 17, 2025
• Study Start: February 15, 2025
• Primary Completion: November 30, 2025
• Study Completion: January 10, 2026
• Last Updated: February 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share