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

University of California (UC) Davis

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Diagnostic Test: Comparison of Biopsy Needle Types for Prostate Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06907446

2262703

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

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

Other group

Treatment:

Diagnostic Test: Comparison of Biopsy Needle Types for Prostate Biopsy