OncotypeDx Prostate – pro
Oncotype DX® Genomic Prostate Score (GPS) (Genomic Health)5 o According to the manufacturer, Oncotype DX prostate cancer assay is a multigene expression profiling assay that produces a genomic prostate score (GPS), ranging from 0-100, representing tumor aggressiveness. The Oncotype DX GPS provides risk stratification to properly classify patients. This test is designed to help patients with newly diagnosed, early-stage PC make informed treatment decisions, including active surveillance. o Oncotype DX GPS uses quantitative RT-PCR for 12 prostate cancer-related genes and 5 control genes (total of 17 genes). It was developed for use with fixed paraffin-embedded (FPE) diagnostic prostate needle biopsies (≥1 mm prostate tumor).
Genomic Health, Inc. (Nasdaq: GHDX) published positive results from its analytical validation study demonstrating that its Oncotype DX prostate cancer test is a reliable assay, even with very limited RNA inputs, which enables successful performance using small amounts of cancer tissue typically available from prostate needle biopsies. Conducted in collaboration with Cleveland Clinic, the aim of this study was to validate the accuracy of the Oncotype DX prostate cancer test by analyzing the test’s precision and accuracy in measuring gene expression over a wide range of conditions commonly encountered with diagnostic prostate biopsies. The Oncotype DX prostate cancer test measures the level of expression of 17 genes across four biological pathways to predict prostate cancer aggressiveness. The test results are reported as a Genomic Prostate Score (GPS) that ranges from 0 to 100 and is combined with other clinical factors, such as PSA and biopsy Gleason Score, to further clarify a man’s risk prior to deciding on a treatment plan. The positive results from a large validation study of this test led by the University of California, San Francisco were presented at the 2013 American Urological Association Annual Meeting. The study suggested that individual biological information from the Oncotype DX prostate cancer test tripled the number of patients who can more confidently consider active surveillance and avoid unnecessary treatment and its potential side effects.The test also identified a smaller number of patients who, despite seemingly low-risk clinical factors, had more aggressive disease and would suggest that they consider immediate treatment, the group that represented about 10 percent of patients.
NCCN says that genetic testing should be considered, including for ” Oncotype DX Prostate: “Cover post-biopsy for NCCN very-low, low-risk, and favorable intermediate-risk prostate cancer in patients with at least 10 years life expectancy who have not received treatment for prostate cancer and are candidates for active surveillance or definitive therapy.” The RTOG definition of high-risk disease is (1) PSA of 20 to 100 ng/mL, biopsy Gleason score of at least 7, and any clinical T stage or (2) PSA less than 100 ng/mL, Gleason score 8 to 10, and clinical T stage cT2c.
NCCN Prostate Pros-1 footnote e, and Pros- E 2022
Chang AJ, Autio KA, Roach M 3rd, Scher HI. High-risk prostate cancer-classification and therapy. Nat Rev Clin Oncol. 2014 Jun;11(6):308-23
AUA Guidelines on Clinically Localized Prostate Cancer, 2017
Clinically Localized Prostate Cancer: ASCO Clinical Practice Guideline Endorsement of an American Urological Association/American Society for Radiation Oncology/Society of Urologic Oncology Guideline, 2018.” J Clin Oncol, 36: 3251-3258.
Chen R, Rumble R, Loblaw D, et al. (2016). “Active surveillance for the management of localized prostate cancer (Cancer Care Ontario Guideline): American Society of Clinical Oncology Clinical Practice Guideline Endorsement.” J Clin Oncol. 2016;34(18):2182-2190.
EAU Guidelines on Prostate Cancer, 2016 4) Ellery B, Parsons J, Merlin T. (2014). “Molecular testing for prostate cancer prognosis.” Technology Brief. Herston, QLD: Department of Health, Queensland; November 2014. 5) NCCN Guidelines on Prostate Cancer, 2018