Comparing Standard of Care Biopsy System to a Novel Biopsy Needle System by Computational Pathologic Analysis
Recruiting
N/A
Interventional Study
Prostate Cancer Screening
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 200 (estimated)
- Sponsor
- Uro-1 Medical · Industry
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About This Trial
Prostate biopsy is the definitive examination to establish the diagnosis of prostate cancer, but up to 40% of these biopsies overestimate or underestimate the severity of the disease. A novel biopsy needle system captures substantially more tissue than standard of care needles, but it is important to assess the retrieval of tissue for pathologic analyses. This study will compare quality and quanti…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adult males with PSA density greater than or equal to 0.15
* Lesions are visible under MRI
* PIRADS score is greater than or equal to 3
* Able to and willing to provide consent
Exclusion Criteria:
* Subject has had previous local prostate therapy, focal therapy, brachytherap…
Contacts