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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm study comparing two different needle biopsy systems for prostate biopsy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number 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. | From prostate biopsy procedure through study completion up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From prostate biopsy procedure through study completion up to 1 year |
| Length of time necessary to diagnose the tissue sample |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc Dall'Era, MD | Contact | 916-734-2893 | mdallera@ucdavis.edu | |
| Elisa Lee | Contact | 916-734-5173 | elilee@ucdavis.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Departments of Urologic Oncology | Recruiting | Sacramento | California | 95817 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Time required from collection of specimen to final diagnosis. |
| Diagnosis within 10 days of the biopsy |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |