UC Davis Departments of Urologic Oncology
Sacramento, California, 95817, United States
Location status: Recruiting
NCT Number: NCT06907446
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.
Interested in participating?
Request Info18 year and older
Male
Interventional
Not applicable
Sacramento, California, 95817, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each patient will undergo a standard of care prostate biopsy according to the clinical indication alternating between the SureCore and standard Bard needle
Time frame: From prostate biopsy procedure through study completion up to 1 year
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
The secondary outcomes will look at the quality of specimen including fragmentation, tortuosity, and spatial orientation of the sample.
Time frame: Diagnosis within 10 days of the biopsy
Time required from collection of specimen to final diagnosis.
Contact information is provided by the study sponsor or research team.
Elisa Lee
CONTACT
Marc Dall'Era, MD
CONTACT
University of California, Davis
Other
Comparison of BARD Max Core 18g Needle With Uro1 SUREcore 18g Needle in Targeted Prostate Biopsies
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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