Recruiting

Biopsy Needle Comparison

Sponsor:

Uro-1 Medical

Code:

NCT06830265

Conditions

Prostate Cancer Screening

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Novel needle biopsy catheter (test)

Study Details

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.

Conditions

Prostate Cancer Screening

Study ID

NCT06830265

Start date

Jul 7, 2025

Status verified date

Sep, 2026

Completion date

Dec 10, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Test group

The prostate of each subject will have a tissue removed by one needle in one lobe and the other needle in the other lobe.

active comparator: Single Arm

The prostate will be biopsied in one lobe by the control needle biopsy system and the other lobe by the test needle biopsy system.

Interventions

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 measure

  • Atypical Small Acinar Proliferation [ Time Frame: From enrollment to end of treatment at 1 day ]
  • Gleason Score [ Time Frame: From enrollment to end of treatment at 1 day ]
  • Tissue area and length [ Time Frame: From treatment to end of pathology review at 2 days ]
  • Tissue toruosity [ Time Frame: From treatment to end of pathology review at 2 days ]

Central Contacts and Locations

Central contacts

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Principal Investigator:

Michael Rothberg, MD

Novant Health Coastal Carolina Medical Center

Recruiting

Hardeeville, South Carolina, United States, 29927

Contacts

Principal Investigator:

Eric Gwynn, MD

More Information

Sponsor

Uro-1 Medical

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Randomized Two-arm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Uro-1 Medical on 2026-09-04.