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

Uro-1 Medical

Status: Not yet enrolling

Conditions: Prostate Cancer Screening

Treatments: Device: Novel needle biopsy catheter (test)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06830265

25-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Test group

Active Comparator group

Description:

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

Treatment:

Device: Novel needle biopsy catheter (test)

Single Arm

Active Comparator group

Description:

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

Treatment:

Device: Novel needle biopsy catheter (test)