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NCT06907446 | RECRUITING | Prostate Cancer


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

University of California, Davis

Information provided by (Responsible Party):

Marc from the era, MD

Brief 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.

Condition or disease

Prostate Cancer

Intervention/treatment

Comparison of Biopsy Needle Types for Prostate Biopsy

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Comparison of BARD Max Core 18g Needle With Uro1 SUREcore 18g Needle in Targeted Prostate Biopsies
Actual Study Start Date : 2025-05-01
Estimated Primary Completion Date : 2026-07
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
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

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

Location Details

NCT06907446


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Locations


RECRUITING

United States, California

UC Davis Departments of Urologic Oncology

Sacramento, California, United States, 95817

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