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

Not Applicable

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06907446
• Lead Sponsor: University of California, Davis

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Study First Posted: 2025-04-02
• Last Update Posted: 2025-04-02
• Study Start: 2025-05-01
• Primary Completion: 2026-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of patients diagnosed with prostate cancer and histological grade of cancer detected	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 Outcome Measures

Name	Time	Method
Quality of Biopsy Specimen Obtained at Time of Prostate Biopsy	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.
Length of time necessary to diagnose the tissue sample	Diagnosis within 10 days of the biopsy	Time required from collection of specimen to final diagnosis.

Trial Locations

Locations (1)

UC Davis Departments of Urologic Oncology; 🇺🇸 Sacramento, California, United States