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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EAdjuvant androgen deprivation therapy (ADT), including a luteinizing hormone-releasing hormone analogue (LHRHA) for 2 to 3 years, is the standard of care before, during, and after radiotherapy for patients with localized prostate cancer at high risk of recurrence. However, the optimal regimen remains unclear. This article discusses the phase 3 trial of Enzalutamide in Androgen Deprivation Therapy with Radiation Therapy for High Risk, Clinically Localized, Prostate Cancer [ENZARAD; Australian New Zealand Clinical Trials Registry ACTRN12614000126617]\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EReproductive Cancers\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EReproductive Cancers\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EAdjuvant androgen deprivation therapy (ADT), including a luteinizing hormone-releasing hormone analogue (LHRHA) for 2 to 3 years, is the standard of care before, during, and after radiotherapy for patients with localized prostate cancer at high risk of recurrence. Although outcomes in patients receiving long-term ADT (18 to 36 months) are superior to those seen in patients receiving 6 months of treatment, the optimal regimen remains unclear.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EScott Williams, PhD, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia, presented the design and objectives for a phase 3 trial of Enzalutamide in Androgen Deprivation Therapy with Radiation Therapy for High Risk, Clinically Localized, Prostate Cancer [ENZARAD; Australian New Zealand Clinical Trials Registry ACTRN12614000126617; Williams S et al. \u003Cem\u003EAnn Oncol\u003C\/em\u003E. 2014], which is currently enrolling patients.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EEnzalutamide is a new second-generation androgen receptor inhibitor that improves survival in metastatic castration-resistant prostate cancer; it is more potent and binds with a higher affinity to androgen receptors than do conventional nonsteroidal antiandrogens (NSAAs).\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EENZARAD is an open-label intergroup trial open to adult men who have localized prostate cancer that is of high risk of recurrence and who are suitable for external beam radiation therapy (EBRT) with the intent to cure. Participants are stratified by Gleason score (7 vs 8 to 10), clinical stage (T1 to T2 vs T3 to T4), prostate-specific antigen (PSA) levels \u2265 10 ng\/mL or \u2265 20 ng\/mL, and study site. Patients are then randomized 1:1 to either enzalutamide (160 mg, daily) for 24 months or conventional NSAAs for 6 months. All participants will receive LHRHA for 24 months and EBRT (78 Gy\/39 F) starting after week 16.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe primary study end point is overall survival. Secondary end points include cause-specific survival, PSA progression-free survival, clinical progression-free survival, time to subsequent hormonal therapy, health-related quality of life, adverse events, and health outcomes relative to cost. A tertiary objective is to identify biomarkers that are prognostic or predictive of response to treatment. Study assessments will be conducted at baseline; weeks 4, 12, 16, 20, and 24; then every 3 to 4 months until year 5, every 6 months until year 7, and annually thereafter. Computed tomography and magnetic resonance imaging and bone scan will be performed at baseline, then as clinically indicated. The tertiary objective will be assessed through archival tumor tissue and data from fasting blood collected at baseline, 24 weeks, 5 years, and first evidence of progression.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThis study opened for recruitment in March 2014, with a planned duration of recruitment of 2 years. As of September 27, 2014, 9 sites were open to recruitment; 84 patients had been screened; and 20 patients had been randomized to treatment. Sites continue to be opened for recruitment in Australia, New Zealand, Ireland, the United Kingdom, and Europe.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EAdditional information on this study is available by e-mail (\u003Cspan class=\u0022em-link\u0022\u003E\u003Cspan class=\u0022em-addr\u0022\u003Eenzarad{at}ctc.usyd.edu.au\u003C\/span\u003E\u003C\/span\u003E) or from the study website: \u003Ca href=\u0022http:\/\/www.anzup.org.au\/\u0022\u003Ehttp:\/\/www.anzup.org.au\/\u003C\/a\u003E.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/36\/18.1.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzm1wd\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}