Comparing Standard of Care Biopsy System to a Novel Biopsy Needle System by Computational Pathologic Analysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Novel needle biopsy catheter (test).
- Who it may be relevant to
- Registry conditions: Prostate Cancer Screening. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Device Novel needle biopsy catheter (test)
Tissue is collected from the prostate by introducing a needle into the prostate and cutting out a sample
Primary outcome measures
- Atypical Small Acinar Proliferation [Time frame: From enrollment to end of treatment at 1 day]
- Gleason Score [Time frame: From enrollment to end of treatment at 1 day]
- Tissue area and length [Time frame: From treatment to end of pathology review at 2 days]
- Tissue toruosity [Time frame: From treatment to end of pathology review at 2 days]
Secondary outcome measures (1)
- Standard Pathology versus Computational Pathology Results [Time frame: From treatment to end of pathology review at 2 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06830265 · 25-001