Prostate Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTComparison 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
Sponsors
University of California, Davis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients diagnosed with prostate cancer and histological grade of cancer detected | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Biopsy Specimen Obtained at Time of Prostate Biopsy | 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. |
| Length of time necessary to diagnose the tissue sample | Diagnosis within 10 days of the biopsy | Time required from collection of specimen to final diagnosis. |
Countries
United States
Contacts
CONTACTMarc Dall'Era, MD
CONTACTElisa Lee
Outcome results
None listed