Comparison of New SUREcore Biopsy of Needle to Standard of Care During Transperineal Prostate Biopsies
Conditions
Prostate CancerSummary
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
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 BiopsyDescription:
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
Secondary Outcome Measures
Quality of Biopsy Specimen Obtained at Time of Prostate Biopsy
Length of time necessary to diagnose the tissue sample
Timeline
Last Updated
July 20, 2025Start Date
April 2, 2025Today
November 9, 2025Completion Date ( Estimated )
December 1, 2027
Sponsors of this trial
Lead Sponsor
University of California, Davis