Target enrollment is 1000 prospectively enrolled subjects with an initial negative biopsy scheduled for repeat biopsy.
Subjects must have had their negative index prostate biopsy procedure within 30 months of being scheduled for their repeat biopsy.
All enrolled subjects will have all core tissues from the initial negative biopsy blinded and tested with the assay.
All subjects will have serum and plasma samples obtained prior to DRE, and a urine sample collected immediately following DRE but in advance of the repeat biopsy; samples will be blinded and sent to MDxHealth for evaluation.
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