Prostate Px – pro
Risk assessment can be useful to clinicians because it allows assessment of risk versus benefit of partcular treatments. Risk assessment methods currently used for newly diagnosed prostate cancer patients have disadvantages. THey include: D’Amico risk categories, Partin probability tables, University of California, San Francisco-Cancer of the Prostate Risk Assessment risk score, and Kattan nomograms; all rely heavily on traditional clinical variables (eg, serum prostate-specific antigen level, Gleason score, and clinical stage) to estimate risk of various outcomes. Using nomograms maximizes the predictive ability of each factor, allowing for an individualized characterization of risk compared with risk categories or probability tables.
Another approach relies of characterization and analysis of the cancer tissue obtained from a patient. Clinical data is integrated with an analysis of each patient’s cancer using spatial analysis of tissue histology and examining molecular biomarkers, such as androgen receptor, associated with disease progression. This approach represents a cutting edge of diagnostic science, sometimes termed, “Personalized Medciine”. The concept that one can individualize cancer therpay based on specific tumor characteristics is attractive but needs to be proven before being widely adapted. As of now, there is little evidence to support it and no guidelines or professional bodies recommending it.
Prostate Dx is one such test. It uses its own method of data analysis derived from a large patient cohort to generate a personalized report that is sent to the physician for discussion with the patient. This processand information remains proprietary and not peer-reviewed. This testing has not been cleared (or reviewed) by the U.S. Food and Drug Administration (FDA) becasue the company has indicated that Prostate Px does not require FDA approval. The test is considered a laboratory developed test (LDT) and is performed in Aureon’s Clinical Laboratory Improvement Act (CLIA)-certified, College of American Pathologists (CAP)-accredited, New York State-regulated laboratory.
Studies are ongoing to improve standardization and to determine whether this test can enhance prediction of prostate cancer recurrence and risk compared with current standard methods. Memorial Sloan-Kettering Cancer Center is currently recruiting candidates for a prospective study to determine if there is a small peptide mass protein pattern in blood that can distinguish men with clinically latent prostate cancer from men with more a more advanced disease state.
Donovan, Michael J., PhD, MD, et al., “Systems Pathology: A Paradigm Shift in the Practice of Diagnostic and Predictive Pathology, Cancer, Vol. 115, No. 13, July 1, 2009, pp. 3078–3084.
Eggener, Scott E., MD, et al., “Comparison of Models to Predict Clinical Failure after Radical Prostatectomy, Cancer, Vol. 115, January 15, 2009, pp. 303-310.
HAYES Update Search, “Prostate Px® (Aureon Laboratories Inc.) for Prediction of Recurrence of Prostate Cancer,” Lansdale, PA: HAYES, Inc., January 6, 2012.