Comparison of New SUREcore Biopsy of Needle to Standard of Care During Transperineal Prostate Biopsies

Clinicaltrials.gov ID: NCT06907446
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 50

Conditions

Prostate Cancer

Summary

To study a novel biopsy needle system for performing transperineal prostate biopsy. Prostate biopsy remains the standard approach for prostate cancer detection. While pre-biopsy MRI allows for targeting of visible lesions, systemic or 'off target' samples are recommended due to the well-recognized risk of undegrading and under sampling with current commercially available needles. The SureCore plus single-use biopsy needle produces a more intact tissue core with a same caliber 18g needle with ~21% more tissue per core in pre-clinical studies. This research study will determine if a new biopsy needle designed to produce more robust tissue cores per sample can improve detection and characterization of prostate cancer.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Eligibility Criteria

Inclusion Criteria:

* Patient older than age of 18 undergoing prostate biopsy

Exclusion Criteria:

* Unable to consent
* Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives
* Prisoners

Study Plan

Single arm study comparing two different needle biopsy systems for prostate biopsy

  • DIAGNOSTIC_TEST:

    Comparison of Biopsy Needle Types for Prostate Biopsy

    Description:

    Each patient will undergo a standard of care prostate biopsy according to the clinical indication alternating between the SureCore and standard Bard needle

Outcome Measures

Primary Outcome Measures

Number of patients diagnosed with prostate cancer and histological grade of cancer detected

Time Frame: From prostate biopsy procedure through study completion up to 1 year

Secondary Outcome Measures

Quality of Biopsy Specimen Obtained at Time of Prostate Biopsy

Time Frame: From prostate biopsy procedure through study completion up to 1 year

Length of time necessary to diagnose the tissue sample

Time Frame: Diagnosis within 10 days of the biopsy

Timeline

  • Last Updated
    July 20, 2025
  • Start Date
    April 2, 2025
  • Today
    November 9, 2025
  • Completion Date ( Estimated )
    December 1, 2027

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