NCT06830265 Comparing Standard of Care Biopsy System to a Novel Biopsy Needle System by Computational Pathologic Analysis
| NCT ID | NCT06830265 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Uro-1 Medical |
| Condition | Prostate Cancer Screening |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-07-07 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-07-07 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Thomas Lawson
STUDY DIRECTOR
Uro-1 Medical
Frequently Asked Questions
Who can join the NCT06830265 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer Screening. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06830265 currently recruiting?
Yes, NCT06830265 is actively recruiting participants. Contact the research team at tlawson@uro1medical.com for enrollment information.
Where is the NCT06830265 trial being conducted?
This trial is being conducted at New York, United States, Durham, United States, Hardeeville, United States.
Who is sponsoring the NCT06830265 clinical trial?
NCT06830265 is sponsored by Uro-1 Medical. The principal investigator is Thomas Lawson at Uro-1 Medical. The trial plans to enroll 200 participants.
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