The objective of this multi-center prospective observational clinical study is to evaluate the clinical performance of the Carisome Prostate assay as an aid in the diagnosis of prostate cancer in men that have been scheduled for a prostate biopsy. Primarily, results of the Carisome Prostate assay will be compared with pathology results of prostate biopsy procedures. Secondarily, the performance of the Carisome Prostate test will be compared to the current standard of care for the detection of prostate cancer.

Inclusion Criteria:

• Men scheduled for a routine prostate biopsy expected to produce a pathology evaluation and report
• Blood draw within 7 days prior to scheduled prostate biopsy procedure
• Blood draw on the day of but prior to biopsy

Exclusion Criteria:

• Any previous diagnosis of cancer with the exception of non-melanoma skin cancer
• Any prior or ongoing treatment for prostate cancer including prostatectomy or hormone therapy
• Prostate biopsy within one month of blood draw
• Previous enrollment in the Caris Life Sciences Biorepository

Men scheduled for routine prostate biopsy