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

Not Applicable

Not yet recruiting

• Conditions: Prostate Cancer Screening

• Registration Number: NCT06830265
• Lead Sponsor: Uro-1 Medical

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.

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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study Start: 2025-02-15
• Study First Posted: 2025-02-17
• Last Update Posted: 2025-02-17
• Primary Completion: 2025-11-30
• Study Completion: 2026-01-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Standard Pathology versus Computational Pathology Results	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