This report focuses on the analytical validity, clinical validity, and clinical utility of the 4Kscore Test to aid in prostate cancer biopsy decision making for physician and patient through: (1) estimating a patient’s percentage of risk for aggressive (Gleason ≥ 7) prostate cancer if a prostate biopsy were performed; and (2) providing information on the 10-year likelihood of developing distant metastases when the 4Kscore result is < 7.5%.

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