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NCT Number: NCT06907446

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Departments of Urologic Oncology

Sacramento, California, 95817, United States

Location status: Recruiting

Location contact

Marc Dall'Era, MD

CONTACT

[email protected]

916-734-2893

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparison of Biopsy Needle Types for Prostate Biopsy

Diagnostic Test

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

Primary outcomes

  1. 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

    The primary outcome will evaluate whether cancer is detected on final pathological analysis. This will include the grade of cancer, percentage of core involved, and compare between the two needles.

Secondary outcomes

  1. Quality of Biopsy Specimen Obtained at Time of Prostate Biopsy

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

    The secondary outcomes will look at the quality of specimen including fragmentation, tortuosity, and spatial orientation of the sample.

  2. Length of time necessary to diagnose the tissue sample

    Time frame: Diagnosis within 10 days of the biopsy

    Time required from collection of specimen to final diagnosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Elisa Lee

CONTACT

[email protected]

916-734-5173

Marc Dall'Era, MD

CONTACT

[email protected]

916-734-2893

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Comparison of BARD Max Core 18g Needle With Uro1 SUREcore 18g Needle in Targeted Prostate Biopsies

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 2, 2025
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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