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.

NCT Number	NCT06907446
Lead Sponsor	University of California, Davis
Conditions	Prostate Cancer
Enrollment	50 participants
Start Date	2025-05-01
Primary Completion	2027-07-01 (estimated)
Study Completion	2027-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-06