Comparison of New SUREcore Biopsy of Needle to Standard of Care During Transperineal Prostate Biopsies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Comparison of Biopsy Needle Types for Prostate Biopsy.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of BARD Max Core 18g Needle With Uro1 SUREcore 18g Needle in Targeted Prostate Biopsies
Overview
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.
Interventions
- 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
Primary outcome measures
- 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]
Secondary outcome measures (2)
- Quality of Biopsy Specimen Obtained at Time of Prostate Biopsy [Time frame: From prostate biopsy procedure through study completion up to 1 year]
- Length of time necessary to diagnose the tissue sample [Time frame: Diagnosis within 10 days of the biopsy]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- UC Davis Departments of Urologic Oncology — Sacramento
Identifiers
NCT: NCT06907446 · 2262703