Prostate Cancer Screening
Conditions
Keywords
Randomized Two-arm
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.
Interventions
DEVICENovel needle biopsy catheter (test)
Tissue is collected from the prostate by introducing a needle into the prostate and cutting out a sample
Sponsors
Uro-1 Medical
Duke University
NYU Langone Health
Novant Health, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTThomas Lawson, PhD
CONTACTTed Belleza, BA
STUDY_DIRECTORThomas Lawson
Uro-1 Medical
Outcome results
None listed