A Study to Assess Mitomic Prostate Test for Prostate Cancer Screening

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.