The Prostate Cancer Assay performance of Celsee Diagnostics circulating tumor cell (CTC) analysis system will be validated in patients diagnosed with metastatic prostate cancer. It will demonstrate substantial performance equivalency to a CTC Assay predicate device.
Study Type
OBSERVATIONAL
Blood draws only - non-diagnostic, non-treatment
Confirmation of the clinical utility of the cutoff level for the Prostate Cancer Assay for prognosis of progression free survival (PFS) in comparison to the predicate device, CellSearch CTC Assay
"CTC negative" means a level of CTCs below the cutoff indicating lower risk for progression (i.e. PFS, and "CTC positive" means a level of CTCs at or above the cutoff indicating higher risk for progression (i.e. shorter PFS).
Time frame: 9 months
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