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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer Screening
• Intervention / Treatment: Device: Novel needle biopsy catheter (test)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ted Belleaza; Phone Number: 831-295-7133; Email: tbelleza@uro1medical.com
• Study Contact Backup: Name: Thomas Lawson, PHD; Phone Number: 510-206-1794; Email: drthomlawson@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Test group; 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); Tissue is collected from the prostate by introducing a needle into the prostate and cutting out a sample
Active Comparator: Single Arm; 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); Tissue is collected from the prostate by introducing a needle into the prostate and cutting out a sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard Pathology versus Computational Pathology Results	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	From treatment to end of pathology review at 2 days

Collaborators and Investigators

• Sponsor: Uro-1 Medical
• Collaborators: NYU Langone Health; Duke University
• Investigators: Study Director: Ted Belleza, Uro-1 Medical

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2025
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): January 10, 2026

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 25-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No