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

Comparison of BARD Max Core 18g Needle With Uro1 SUREcore 18g Needle in Targeted 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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: Comparison of Biopsy Needle Types for Prostate Biopsy

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc Dall'Era, MD; Phone Number: 916-734-2893; Email: mdallera@ucdavis.edu
• Study Contact Backup: Name: Elisa Lee; Phone Number: 916-734-5173; Email: elilee@ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • UC Davis Departments of Urologic Oncology
      • Contact: Marc Dall'Era, MD; Phone Number: 916-734-2893; Email: mdallera@ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single arm study comparing two different needle biopsy systems for prostate biopsy	Diagnostic test: Comparison of Biopsy Needle Types for Prostate Biopsy; Each patient will undergo a standard of care prostate biopsy according to the clinical indication alternating between the SureCore and standard Bard needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Biopsy Specimen Obtained at Time of Prostate Biopsy	The secondary outcomes will look at the quality of specimen including fragmentation, tortuosity, and spatial orientation of the sample.	From prostate biopsy procedure through study completion up to 1 year
Length of time necessary to diagnose the tissue sample	Time required from collection of specimen to final diagnosis.	Diagnosis within 10 days of the biopsy

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2262703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No