Proposed LCD - MolDX: Gene Expression Profile Tests for Decision-Making in Castration Resistant and Metastatic Prostate Cancers (DL39648)

Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023.CA Cancer J Clin. 2023;73(1):17-48. doi:10.3322/caac.21763Basourakos SP, Gulati R, Vince RA Jr, et al. Harm-to-benefit of three decades of prostate cancer screening in black men.NEJM Evid. 2022;1(6).Awasthi S, Grass GD, Torres-Roca J, et al. Genomic testing in localized prostate cancer can identify subsets of African Americans with aggressive disease.J Natl Cancer Inst. 2022;114(12):1656-1664. doi:10.1093/jnci/djac162Siegel DA, O'Neil ME, Richards TB, Dowling NF, Weir HK. Prostate cancer incidence and survival, by stage and race/ethnicity - United States, 2001-2017.MMWR Morb Mortal Wkly Rep. 2020;69(41):1473-1480. doi:10.15585/mmwr.mm6941a1Dai C, Heemers H, Sharifi N. Androgen signaling in prostate cancer.Cold Spring Harb Perspect Med. 2017;7(9):a030452.Sweeney CJ, Chen YH, Carducci M, et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer.N Engl J Med. 2015;373(8):737-746. doi:10.1056/NEJMoa1503747James ND, Sydes MR, Clarke NW, et al. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial.Lancet. 2016;387(10024):1163-1177. doi:10.1016/S0140-6736(15)01037-5Fizazi K, Tran N, Fein L, et al. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer.N Engl J Med. 2017;377(4):352-360. doi:10.1056/NEJMoa1704174Beer TM, Armstrong AJ, Rathkopf DE, et al. Enzalutamide in metastatic prostate cancer before chemotherapy.N Engl J Med. 2014;371(5):424-433. doi:10.1056/NEJMoa1405095Armstrong AJ, Szmulewitz RZ, Petrylak DP, et al. ARCHES: a randomized, phase III study of androgen deprivation therapy with enzalutamide or placebo in men with metastatic hormone-sensitive prostate cancer.J Clin Oncol. 2019;37(32):2974-2986. doi:10.1200/JCO.19.00799NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Prostate Cancer. Version 1.2023.Virgo KS, Rumble RB, de Wit R, et al. Initial management of noncastrate advanced, recurrent, or metastatic prostate cancer: ASCO guideline update.J Clin Oncol. 2021;39(11):1274-1305. doi:10.1200/JCO.20.03256Lowrance W, Dreicer R, Jarrard DF, et al. Updates to advanced prostate cancer: AUA/SUO guideline (2023).J Urol. 2023;209(6):1082-1090. doi:10.1097/JU.0000000000003452Cancer Genome Atlas Research Network. The molecular taxonomy of primary prostate cancer.Cell. 2015;163(4):1011-1025. doi:10.1016/j.cell.2015.10.025Robinson D, Van Allen EM, Wu YM, et al. Integrative clinical genomics of advanced prostate cancer.Cell. 2015;161(5):1215-1228. doi:10.1016/j.cell.2015.05.001Ryan S, Jenkins MA, Win AK. Risk of prostate cancer in Lynch syndrome: a systematic review and meta-analysis.Cancer Epidemiol Biomarkers Prev. 2014;23(3):437-449. doi:10.1158/1055-9965.EPI-13-1165Castro E, Goh C, Olmos D, et al. Germline BRCA mutations are associated with higher risk of nodal involvement, distant metastasis, and poor survival outcomes in prostate cancer.J Clin Oncol. 2013;31(14):1748-1757. doi:10.1200/JCO.2012.43.1882Messina C, Cattrini C, Soldato D, et al. BRCA mutations in prostate cancer: prognostic and predictive implications.J Oncol. 2020;2020:4986365. doi:10.1155/2020/4986365de Bono J, Mateo J, Fizazi K, et al. Olaparib for metastatic castration-resistant prostate cancer.N Engl J Med. 2020;382(22):2091-2102. doi:10.1056/NEJMoa1911440Gillette CM, Yette GA, Cramer SD, Graham LS. Management of advanced prostate cancer in the precision oncology era.Cancers (Basel). 2023;15(9):2552. doi:10.3390/cancers15092552Pritchard CC, Mateo J, Walsh MF, et al. Inherited DNA-repair gene mutations in men with metastatic prostate cancer.N Engl J Med. 2016;375(5):443-453. doi:10.1056/NEJMoa1603144Erho N, Crisan A, Vergara IA, et al. Discovery and validation of a prostate cancer genomic classifier that predicts early metastasis following radical prostatectomy.PLoS One. 2013;8(6):e66855.Kim HL, Li P, Huang HC, et al. Validation of the Decipher Test for predicting adverse pathology in candidates for prostate cancer active surveillance.Prostate Cancer Prostatic Dis. 2019;22(3):399-405. doi:10.1038/s41391-018-0101-6Spratt DE, Yousefi K, Deheshi S, et al. Individual patient-level meta-analysis of the performance of the decipher genomic classifier in high-risk men after prostatectomy to predict development of metastatic disease.J Clin Oncol. 2017;35(18):1991-1998.Srlie T, Perou CM, Tibshirani R, et al. Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications.Proc Natl Acad Sci U S A. 2001;98(19):10869-10874. doi:10.1073/pnas.191367098Wallden B, Storhoff J, Nielsen T, et al. Development and verification of the PAM50-based Prosigna breast cancer gene signature assay.BMC Med Genomics. 2015;8:54.Parker JS, Mullins M, Cheang MC, et al. Supervised risk predictor of breast cancer based on intrinsic subtypes.J Clin Oncol. 2009;27(8):1160-1167. doi:10.1200/JCO.2008.18.1370Choi W, Porten S, Kim S, et al. Identification of distinct basal and luminal subtypes of muscle-invasive bladder cancer with different sensitivities to frontline chemotherapy.Cancer Cell. 2014;25(2):152-165. doi:10.1016/j.ccr.2014.01.009Zhao SG, Chang SL, Erho N, et al. Associations of luminal and basal subtyping of prostate cancer with prognosis and response to androgen deprivation therapy.JAMA Oncol. 2017;3(12):1663-1672. doi:10.1001/jamaoncol.2017.0751Zhao SG, Chen WS, Das R, et al. Clinical and genomic implications of luminal and basal subtypes across carcinomas.Clin Cancer Res. 2019;25(8):2450-2457. doi:10.1158/1078-0432.CCR-18-3121Spratt DE, Alshalalfa M, Fishbane N, et al. Transcriptomic heterogeneity of androgen receptor activity defines ade novolow ar-active subclass in treatment nave primary prostate cancer.Clin Cancer Res. 2019;25(22):6721-6730. doi:10.1158/1078-0432.CCR-19-1587Kyriakopoulos CE, Chen YH, Carducci MA, et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer: long-term survival analysis of the randomized phase III E3805 CHAARTED trial.J Clin Oncol. 2018;36(11):1080-1087. doi:10.1200/JCO.2017.75.3657Hamid AA, Huang HC, Wang V, et al. Transcriptional profiling of primary prostate tumor in metastatic hormone-sensitive prostate cancer and association with clinical outcomes: correlative analysis of the E3805 CHAARTED trial.Ann Oncol. 2021;32(9):1157-1166. doi:10.1016/j.annonc.2021.06.003Smith MR, Saad F, Chowdhury S, et al. Apalutamide treatment and metastasis-free survival in prostate cancer.N Engl J Med. 2018;378(15):1408-1418. doi:10.1056/NEJMoa1715546Feng FY, Thomas S, Saad F, et al. Association of molecular subtypes with differential outcome to apalutamide treatment in nonmetastatic castration-resistant prostate cancer.JAMA Oncol. 2021;7(7):1005-1014. doi:10.1001/jamaoncol.2021.1463Aggarwal R, Rydzewski NR, Zhang L, et al. Prognosis associated with luminal and basal subtypes of metastatic prostate cancer.JAMA Oncol. 2021;7(11):1644-1652. doi:10.1001/jamaoncol.2021.3987Alumkal JJ, Sun D, Lu E, et al. Transcriptional profiling identifies an androgen receptor activity-low, stemness program associated with enzalutamide resistance.Proc Natl Acad Sci U S A. 2020;117(22):12315-12323. doi:10.1073/pnas.1922207117Zhang D, Park D, Zhong Y, et al. Stem cell and neurogenic gene-expression profiles link prostate basal cells to aggressive prostate cancer.Nat Commun. 2016;7:10798.Coleman IM, DeSarkar N, Morrissey C, et al. Therapeutic implications for intrinsic phenotype classification of metastatic castration-resistant prostate cancer.Clin Cancer Res. 2022;28(14):3127-3140. doi:10.1158/1078-0432.CCR-21-4289Labrecque MP, Coleman IM, Brown LG, et al. Molecular profiling stratifies diverse phenotypes of treatment-refractory metastatic castration-resistant prostate cancer.J Clin Invest. 2019;129(10):4492-4505.Beltran H, Prandi D, Mosquera JM, et al. Divergent clonal evolution of castration-resistant neuroendocrine prostate cancer.Nat Med. 2016;22(3):298-305. doi:10.1038/nm.4045Kumar A, Coleman I, Morrissey C, et al. Substantial interindividual and limited intraindividual genomic diversity among tumors from men with metastatic prostate cancer.Nat Med. 2016;22(4):369-378. doi:10.1038/nm.4053Aryee MJ, Liu W, Engelmann JC, et al. DNA methylation alterations exhibit intraindividual stability and interindividual heterogeneity in prostate cancer metastases.Sci Transl Med. 2013;5(169):169ra10. doi:10.1126/scitranslmed.3005211Liu W, Laitinen S, Khan S, et al. Copy number analysis indicates monoclonal origin of lethal metastatic prostate.Nat Med. 2009;15(5):559-565. doi:10.1038/nm.1944Sathianathen NJ, Philippou YA, Kuntz GM, et al. Taxane-based chemohormonal therapy for metastatic hormone-sensitive prostate cancer.Cochrane Database Syst Rev. 2018;10(10):CD012816.