Gene expression profile analysis and protein biomarkers have been proposed as a means to risk-stratify individuals with prostate cancer to guide treatment decisions. These tests are intended to be used either on prostate needle-biopsy tissue to guide management regarding active surveillance versus therapeutic intervention, or after radical prostatectomy to guide radiotherapy decisions.
Given the unpredictable behavior of early prostate cancer, additional prognostic methods to biologically stratify this disease are under investigation. These include gene expression profiling, which refers to analysis of mRNA expression levels of many genes simultaneously in a tumor specimen, and protein biomarkers. Examples of array-based gene expression profiling tests now offered commercially are: the Prolaris® (Myriad Genetics), the Oncotype Dx® Prostate Cancer Assay (Genomic Health) and Decipher® Prostate Cancer Classifier (GenomeDX Biosciences).
Gene expression profile analysis to guide the management of prostate cancer is considered investigational.
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There is insufficient data to establish the clinical validity or clinical utility of this technology to guide management decisions in prostate cancer care at this time.
Badani, K., Kemeter, M., Febbo, P., Lawrence, J., Denes, B., Rothney, M., et al. (2015). The impact of a biopsy based 17-gene genomic prostate score on treatment recommendations in men with newly diagnosed clinically prostate cancer who are candidates for active surveillance. Urology Practice, Vol. 2, 181-189. (Level 4 evidence)
BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2017). Gene expression profiling and protein biomarkers for prostate cancer management (2.04.111). Retrieved July 9, 2018 from BlueWeb. (108 articles and/or guidelines reviewed)
Cullen, J., Rosner, I., Brand, T., Zhang, N., Tsiatis, A., Moncur, J., et al. (2015). A biopsy-based 17-gene genomic prostate score predicts recurrence after radical prostatectomy and adverse surgical pathology in a racially diverse population of men with clinically low- and intermediate-risk prostate cancer. European Urology, 68 (1), 123-131. (Level 4 evidence)
Cuzick, J., Stone, S., Fisher, G., Yang, Z., North, B., Berney, D., et al. (2015). Validation of an RNA cell cycle progression score for predicting death from prostate cancer in a conservatively managed needle biopsy cohort. British Journal of Cancer, 113, 382-389. (Level 4 evidence)
Klein, E.A., Cooperberg, M.R., Magi-Galluzzi, C., Simko, J.P., Falzarano, S.M., Maddala, T., et al. (2014). A 17-gene assay to predict prostate cancer aggressiveness in the context of Gleason grade heterogeneity, tumor multifocality, and biopsy understanding. European Urology, 66 (3), 550-560. Abstract retrieved July 9, 2018 from PubMed database.
Knezevic, D., Goddard, A., Natraj, N., Cherbavaz, D., Clark-Langone, K.M., Snable, J., et al. (2013). Analytical validation of the Oncothype DX prostate cancer assay - a clinical RT-PCR assay optimized for prostate needle biopsies. BMC Genomics, 14, 690. (Level 4 evidence)
Koch, M., Cho, J., Kaimakliotis, Z., Cheng, L., Sangale, Z., Brawer, M., et al. (2016). Use of the cell cycle progression (CCP) score for predicting systemic disease and response to radiation of biochemical recurrence. Cancer Biomarkers, 17, 83-88. (Level 4 evidence)
Lynch, J., Rothney, M., Salup, R., Ercole, C., Mathur, S., Duchene, D., et al. (2018). Improving risk stratification among veterans diagnosed with prostate cancer: impact of the 17-gene genomic prostate score assay. American Journal of Managed Care, 24 (1 Suppl), S4-S10. (Level 4 evidence)
Moschini, M., Spahn, M., Mattei, A., Cheville, J., and Karnes, J. (2016) Incorporation of tissue-based genomic biomarkers into localized prostate cancer clinics. BMC Medicine, 14, 67. (Level 2 evidence)
National Comprehensive Cancer Network. (2018). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Prostate cancer (V.3.2018). Retrieved July 9, 2018 from the National Comprehensive Cancer Network.
Palmetto Government Benefit Administrators. (2018, April). LCD: MolDX: Oncotype DX® genomic prostate score for men with favorable intermediate risk prostate cancer (L37262). Retrieved July 9, 2018 from www.cms.org.
Palmetto Government Benefit Administrators. (2018, February). LCD: MolDX: Genomic Health™ Oncotype DX® prostate cancer assay (L36153). Retrieved July 9, 2018 from www.cms.org.
Rubicz, R., Zhao, S., April, C., Wright, J., Kolb, S., Coleman, I., et al. Expression of cell cycle-regulated genes and prostate cancer prognosis in a population-based cohort. Prostate, 75 (13), 1354-1362. Abstract retrieved August 30, 2016 from PubMed database.
Salmasi, A., Said, J., Shindel, A.W., Khoshnoodi, P, Felker, E.R., Sisk, A.E., et al. (2018). A 17-gene genomic prostate score assay provides independent information on adverse pathology in the setting of combined multiparametric magnetic resonance imaging fusion targeted and systematic prostate biopsy. Journal of Urology, Epub ahead of print. Doi: 10.1016/j.juro.2018.03.004. Abstract retrieved July 9, 2018 from PubMed database.
Sommariva, S., Tarricone, R., Lazzeiri, M., Ricciardi, W., & Montorsi, F. (2016). Prognostic value of the cell cycle progression score in patients with prostate cancer: a systematic review and meta-analysis. European Urology, 69 (1), 107-115. Abstract retrieved August 30, 2016 from PubMed database.
Technology Evaluation Center. (2015, January). Gene expression analysis for prostate cancer management. (Volume 29, No. 9). Retrieved August 30, 2016 from http://bluewebportal.bcbs.com. (59 articles and/or guidelines reviewed)
Van Den Eeden, S.K., Lu, R., Zhang, N., Quesenberry, C.P., Shan, J, Han, J.S., et al. (2018). A biopsy-based 17-gene genomic prostate score as a predictor of metastases and prostate cancer death in surgically treated men with clinically localized disease. European Urology, 73 (1), 129-138. Abstract retrieved July 9, 2018 from PubMed database.
MOST RECENT REVIEW DATE: 8/9/2018
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