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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
Each patient will undergo a standard of care prostate biopsy according to the clinical indication alternating between the SureCore and standard Bard needle
UC Davis Departments of Urologic Oncology
Sacramento, California, United States
RECRUITINGNumber 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.
Time frame: From prostate biopsy procedure through study completion up to 1 year
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.
Time frame: 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.
Time frame: Diagnosis within 10 days of the biopsy
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