NCT06830265 · Uro-1 Medical
Comparing Standard of Care Biopsy System to a Novel Biopsy Needle System by Computational Pathologic Analysis
What this study is 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 the usual treatment needles, but it is important to assess the retrieval of tissue for pathologic analyses.
View original scientific description
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.
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
Presence of suspicious prostate gland cells that appear cancerous but are not definitive enough to diagnose cancer
Gleason Score
Time frame: 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
Time frame: 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
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
- Durham, North Carolina
- Hardeeville, South Carolina
Collaborators
Duke University, NYU Langone Health, Novant Health, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 4, 2026 · Source of record for eligibility and locations