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

NCT06907446 | Recruiting FDA Device

• 1 other identifier: 2262703
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Number of patients diagnosed with prostate cancer and histological grade of cancer detected

  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.

  From prostate biopsy procedure through study completion up to 1 year

Secondary Outcomes (2)

• Quality of Biopsy Specimen Obtained at Time of Prostate Biopsy

  From prostate biopsy procedure through study completion up to 1 year

• Length of time necessary to diagnose the tissue sample

  Diagnosis within 10 days of the biopsy

Study Arms (1)

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

OTHER

Diagnostic Test: Comparison of Biopsy Needle Types for Prostate Biopsy

Interventions

Comparison of Biopsy Needle Types for Prostate Biopsy DIAGNOSTIC_TEST

Each patient will undergo a standard of care prostate biopsy according to the clinical indication alternating between the SureCore and standard Bard needle

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient older than age of 18 undergoing prostate biopsy

You may not qualify if:

• Unable to consent
• Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives
• Prisoners

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Departments of Urologic Oncology

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Marc Dall'Era, MD

CONTACT

916-734-2893; mdallera@ucdavis.edu

Elisa Lee

CONTACT

916-734-5173; elilee@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: April 2, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)