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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-15

Study Completion Date

2026-01-10

Brief Summary

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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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Detailed Description

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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.

Conditions

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Prostate Cancer Screening

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Novel needle biopsy catheter (test)

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Novel needle biopsy catheter (test)

Intervention Type DEVICE

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

Interventions

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Novel needle biopsy catheter (test)

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No