Clinical trial NCT06830265: Comparing Standard of Care Biopsy System to a Novel Biopsy Needle System by Computational Pathologic Analysis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer Screening
Lead sponsor: Uro-1 Medical
Sponsor class: INDUSTRY
Collaborators: name: Duke University
name: NYU Langone Health
First posted: 2025-02-17
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Atypical Small Acinar Proliferation
timeFrame: From enrollment to end of treatment at 1 day
measure: Gleason Score
timeFrame: From enrollment to end of treatment at 1 day
measure: Tissue area and length
timeFrame: From treatment to end of pathology review at 2 days
measure: Tissue toruosity
timeFrame: From treatment to end of pathology review at 2 days
Secondary outcomes:
measure: Standard Pathology versus Computational Pathology Results
timeFrame: From treatment to end of pathology review at 2 days
Other outcomes:
Locations:
Study officials:
affiliation: Uro-1 Medical
name: Ted Belleza
role: STUDY_DIRECTOR
References: