Compare standard prostate biopsy needles with a novel needle system
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.
Run by Uro-1 Medical · NCT06830265 · Data updated 2026-11-12
A new biopsy needle system is tested against the standard one to see if it retrieves more tissue for analysis and if the tissue quality helps pathologists better diagnose prostate cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 200 (estimated) |
| Sponsor | Uro-1 Medical Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (New York, New York and 2 other locations) |
| Status | Recruiting |
| Started | July 7, 2025 |
| Main results expected | November 1, 2026 |
| Study ends | December 10, 2026 |
| Registry record updated | September 4, 2026 |
| Trial ID | NCT06830265 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult men with MRI-visible prostate lesions, PIRADS ≥ 3, and PSA density ≥ 0.15 who can provide consent and meet other criteria.
✕Probably not a fit
Individuals with prior prostate therapies, certain medical conditions, or non-English literacy may not experience a diagnostic benefit from this device.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial compares a novel needle biopsy catheter to the standard care device in men undergoing prostate biopsy. Pathologists, blinded to which device was used, will analyze tissue quantity, quality, and features like area, length, and tortuosity using computational pathology. The study also assesses how the two devices affect diagnostic ambiguity and Gleason-related measurements derived from the tissue samples. Enrollment targets adult men with MRI-visible lesions and sufficiently elevated PSA density, while excluding those with prior relevant therapies or active infections. Results could inform whether the new device improves tissue retrieval and diagnostic clarity.
Why it matters
Potential benefit: If successful, participants may benefit from higher-quality biopsy tissue that could improve diagnostic accuracy and future management.
How similar studies have gone: Previous work suggests tissue retrieval can influence diagnostic accuracy, but this exact computational-pathology analysis with a novel needle is novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Duke University
Durham, North Carolina, United States Recruiting -
Novant Health Coastal Carolina Medical Center
Hardeeville, South Carolina, United States Recruiting -
NYU Langone
New York, New York, United States Active not recruiting
Study contacts
- Study coordinator: Thomas Lawson, PhD
- Email: tlawson@uro1medical.com
- Phone: 510-206-1794
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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PSMA PET/MRI-guided prostate biopsy for men with prior negative biopsies and low PI-RADS
This trial will try whether PSMA PET/MRI-guided targeted biopsies find more clinically significant prostate cancer than standard TRUS transperineal saturation biopsies in men with prior negative biopsies, rising PSA or PHI, and PI-RADS ≤3.
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Comparing micro-ultrasound and MRI for prostate cancer screening
This study tests whether high-resolution micro-ultrasound works better than MRI for screening prostate cancer in men aged 50 to 70.
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Comparing a new prostate biopsy system to standard biopsy methods
This study is testing a new prostate biopsy system to see if it collects better tissue samples than the standard biopsy method for men needing a biopsy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.