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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\u003ESkeletal metastases are common in prostate cancer, occurring in approximately 90% of men with advanced disease. Bone metastases result in decreased quality of life by causing problems such as bone pain, morbidity, pathologic fracture, and spinal cord compression. This article discusses the Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone\/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-Na\u00efve Subjects With Bone Predominant Metastatic Castration-Resistant Prostate Cancer trial [ERA 223; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT02043678\u0026amp;atom=%2Fspmdc%2F14%2F36%2F17.atom\u0022\u003ENCT02043678\u003C\/a\u003E].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EReproductive Cancers\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EReproductive Cancers\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EMatthew R. Smith, MD, PhD, Massachusetts General Hospital, Boston, Massachusetts, USA, discussed the Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone\/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-Na\u00efve Subjects With Bone Predominant Metastatic Castration-Resistant Prostate Cancer (CRPC) trial [ERA 223; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT02043678\u0026amp;atom=%2Fspmdc%2F14%2F36%2F17.atom\u0022\u003ENCT02043678\u003C\/a\u003E] that is now recruiting patients with bone metastases and CRPC.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EAccording to Dr Smith, skeletal metastases are common in prostate cancer, occurring in approximately 90% of men with advanced disease. Bone metastases result in decreased quality of life by causing problems such as bone pain, morbidity, pathologic fracture, and spinal cord compression [Autio K, Morris MJ. \u003Cem\u003EClin Adv Hematol Oncol\u003C\/em\u003E. 2013].\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EAlthough approximately half of patients with metastatic prostate cancer are asymptomatic and may not be good candidates for immediate chemotherapy, they may benefit from alternate therapies [National Comprehensive Cancer Network. \u003Cem\u003EClinical Practice Guidelines in Oncology: Prostate Cancer\u003C\/em\u003E v2. 2014; Cookson MS et al. \u003Cem\u003ECastration-Resistant Prostate Cancer: American Urological Association (AUA) Guideline\u003C\/em\u003E. 2014].\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EA first-in-class \u03b1-radiopharmaceutical that selectively targets bone metastases, radium-223 has gained US Food and Drug Administration approval for use based primarily on increased overall survival (OS) demonstrated in the large, randomized, placebo-controlled phase 3 ALSYMPCA trial [Parker C et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2013; \u003Ca href=\u0022http:\/\/www.fda.gov\/Drugs\/InformationOnDrugs\/ApprovedDrugs\/ucm352393.htm\u0022\u003Ehttp:\/\/www.fda.gov\/Drugs\/InformationOnDrugs\/ApprovedDrugs\/ucm352393.htm\u003C\/a\u003E].\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003ECompared with placebo, radium-223 prolonged OS by 3.6 months and delayed time to first symptomatic skeletal event (SSE) by 5.8 months in patients with CRPC with symptomatic bone metastases when added to best standard of care [Parker C et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2013]. It also demonstrated a favorable safety profile with low rates of myelosuppression, which supports combining it with other agents, noted Dr Smith.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EHe added that abiraterone plus prednisone is a standard of care for patients with CRPC who are not eligible for docetaxel because they are asymptomatic or mildly symptomatic. Abiraterone produces OS and radiographic progression-free survival benefits, and significantly delays clinical deterioration and initiation of chemotherapy in patients with metastatic CRPC (mCRPC) [Ryan CJ et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2014].\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EAccording to Dr Smith, the different modes of action of radium-223 and abiraterone, and their non-overlapping toxicity profiles, suggest that a combination of the 2 treatment options will prolong SSE-free survival compared with abiraterone alone.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EConsequently, ERA 223 was designed to prospectively evaluate combination therapy with abiraterone acetate and prednisone in combination with radium-223 in men with asymptomatic or mildly symptomatic, chemotherapy-na\u00efve, bone-predominant mCRPC.\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EThe study will accrue patients with bone metastases (both symptomatic and asymptomatic) and CRPC. It will include men (\u2265 18 years with a life expectancy \u2265 6 months) with pathologically confirmed prostatic adenocarcinoma that is castration-resistant, with \u2265 2 bone metastases within 4 weeks prior to randomization.\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EExclusion criteria include prior treatment with abiraterone or cytotoxic chemotherapy, and a history of visceral or brain metastasis.\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003EApproximately 800 eligible subjects will be randomized 1:1 to abiraterone acetate (1000 mg QD) and oral prednisone (5 mg BID) plus radium-223 (50 kBq\/kg body weight intravenously, every 4 weeks for 6 cycles) or abiraterone acetate and prednisone plus placebo.\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003EThe primary end points are SSE-free survival, with a key secondary end point of OS. In order to determine safety and OS, the long-term follow up consisted of a phone call every 6 months until 7 years after the last dose of radium-223 or death.\u003C\/p\u003E\u003Cp id=\u0022p-14\u0022\u003EDuring the study, patients will be evaluated at each treatment visit for efficacy, safety, and health-related quality of life. Disease progression and long-term safety will also be assessed every 3 months. Upon completion of radium-223 treatment, all subjects will continue to receive abiraterone plus prednisone until occurrence of an SSE or death.\u003C\/p\u003E\u003Cp id=\u0022p-15\u0022\u003EThis trial is currently recruiting participants, with 74 enrolled as of September 5, 2014, concluded Dr Smith.\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\/17.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"}