The potential usefulness of ProMark is that the test supports physicians in determining which patients with early Prostate Cancer are candidates for active surveillance or observation and are more likely to have a good outcome without needing to receive definitive treatment. Conversely men who have more aggressive malignancy despite favorable clinicopathologic parameters can be counseled for curative therapy.
The ProMark test result should be interpreted in conjunction with NCCN guidelines and other laboratory and clinical data available to the clinician.
The ProMark report provides the patient's ProMark score (Range 1-100) and corresponding predicted risk (%) of aggressive disease based upon his ProMark molecular signature alone. The report also provides the patient's predicted risk (%) across a range of NCCN risk categories, allowing the patient and physician to evaluate the patient's risk in the context of his other clinical and pathologic factors. The report was developed and tested extensively with treating urologists to ensure clarity and to optimize its usefulness in aiding therapeutic decision making.
The ProMark Score was shown to independently predict the likelihood of aggressive Prostate Cancer in both the univariate and multivariate analyses which included PSA and Gleason score. A ProMark Score provides information on the overall aggressiveness of the Prostate Cancer tumor, which should be used in conjunction with other laboratory and clinical information available to the clinician to aid in medical management decisions.
As a criterion for coverage, physicians ordering the ProMark test for their appropriate Medicare patients are expected to use the results to determine treatment between definitive therapy and conservative management. Regardless of management selection, Prostate Cancer patients should be followed by their provider as detailed in relevant clinical guidelines (e.g. NCCN)
As part of the CTR requirements, to ensure the benefits of the ProMark test outweigh any risks, physicians should discuss risks and appropriate monitoring with their patient.