Recruiting

SUREcore vs. Standard

Sponsor:

UCLA

Code:

NCT06907446

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Comparison of Biopsy Needle Types for Prostate Biopsy

Study Details

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

Study ID

NCT06907446

Start date

May 1, 2025

Status verified date

Aug, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

Interventions

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

Primary outcome measure

  • Number of patients diagnosed with prostate cancer and histological grade of cancer detected [ Time Frame: From prostate biopsy procedure through study completion up to 1 year ]

Central Contacts and Locations

Locations

UC Davis Departments of Urologic Oncology

Recruiting

Sacramento, California, United States, 95817

Contacts

More Information

Sponsor

University of California, Davis

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-08-06.