Inclusion Criteria:  Men of screening age (≧45) who are scheduled for prostate needle biopsy due to suspicion of prostate cancer and have a total PSA < 10ng/ml within the previous 3 months. Extended Sextant biopsy pattern that must include a minimum of 12 cores. MRI targeted biopsy preferred where available. Age, total PSA, biopsy pathology, prostate medication history, and ethnicity data must be available; The index biopsy must occur following and within 16 weeks of blood draw.  Exclusion Criteria:  Subject does not undergo their prostate biopsy within 16 weeks of collection of pre-biopsy blood sample; Previous diagnosis of prostate cancer; Prostate biopsy within the previous 3 months; Men with a total PSA>10ng/ml within the previous 3 months; Provides less than the required amount of blood; Considered incompetent to provide informed consent; Does not understand and read language of informed consent; Age, total PSA, biopsy pathology information, medication history or ethnicity data unavailable; Males who are not of screening age (<45); Subjects whose classification as cancer positive or negative is undetermined following biopsy due to suspicious results such as Atypical Suspicious Acinar Proliferation (ASAP); Blood collected after index biopsy. Subject is taking antibiotics at the time of blood collection or has taken antibiotics within the 2 weeks prior to blood collection.