NCT06830265Recruiting
Comparing Standard of Care Biopsy System to a Novel Biopsy Needle System by Computational Pathologic Analysis
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.
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 22 Jan 2025
- Start date
- 7 Jul 2025
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Uro-1 Medical
- Diseases
- Prostate cancer
- NCT number
- NCT06830265
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 7 Jul 2025 to the primary completion date, 1 Nov 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject has had previous local prostate therapy, focal therapy, brachytherapy, ADT, surgery, or chemotherapy for prostate cancer
- Has concurrent malignancies
Other illness
- History of dementia, cognitive impairment, or deep vein thrombosis (DVT)
- Is a prisoner currently or has a history of incarceration
- Has metastatic prostate cancer or a tumor stage of T2c, T3, or T4
- Is positive for HIV, HBV, and/or HCV infection
Other
- Unable to understand English
- Has low-performance status
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Novant Health Coastal Carolina Medical Center Coordinator of this site? Confirm its status | Hardeeville | United States | Recruiting |
| NYU Langone Coordinator of this site? Confirm its status | New York | United States | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.