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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT06907446
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
Jul 2025
Primary completion
Jul 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

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

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

Locations (1)

FacilityCityStateZIPSite coordinators
UC Davis Departments of Urologic OncologySacramentoCalifornia95817
Marc Dall'Era, MD
[email protected]
916-734-2893

Find similar trials in Sacramento, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
UC Davis Departments of Urologic Oncology· Sacramento, CA

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