You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) IV (MP79)1 Apr 2020MP79-05 NEOADJUVANT APALUTAMIDE (ARN-509) AND RADICAL PROSTATECTOMY IN TREATMENT OF INTERMEDIATE TO HIGH RISK PROSTATE CANCER (NEAR) PHASE II TRIAL XinYan Yang*, Edwin Jonathan Aslim, Nye Thane Ngo, Li Yan Khor, Tsung Wen Chong, John Shyi Peng Yuen, Kae Jack Tay, Henry Sun Sien Ho, and Lui Shiong Lee XinYan Yang*XinYan Yang* More articles by this author , Edwin Jonathan AslimEdwin Jonathan Aslim More articles by this author , Nye Thane NgoNye Thane Ngo More articles by this author , Li Yan KhorLi Yan Khor More articles by this author , Tsung Wen ChongTsung Wen Chong More articles by this author , John Shyi Peng YuenJohn Shyi Peng Yuen More articles by this author , Kae Jack TayKae Jack Tay More articles by this author , Henry Sun Sien HoHenry Sun Sien Ho More articles by this author , and Lui Shiong LeeLui Shiong Lee More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000971.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Apalutamide (ARN-509) exert near total antagonist activity at androgen receptors and is approved for treatment of M0 CRPC. ARN-509 as neoadjuvant treatment in organ confined disease has not been studied before. The NEAR trial is a phase II single arm study of neoadjuvant apalutamide (ARN-509) and radical prostatectomy (RP) in the treatment of D’Amico intermediate and high-risk prostate cancer (Clinicaltrials.gov identifier: NCT03124433). This study aims to report on the oncological and pathological outcomes of neoadjuvant ARN-509 before RP. METHODS: Eligibility criteria included patients between 21-75 years old diagnosed with conventional adenocarcinoma, excluding those with radio-recurrent disease, impaired liver function, and poor ECOG status (3 or below). Participants received ARN509 240mg daily for 12 weeks followed by RP within 6 weeks of the last dose of medication. Primary outcomes included tumour response defined by residual cancer burden (RCB), post-therapy morphologic characterization (groups A-C, with C being the worst response), and post-operative serum PSA levels (nadir defined as levels below 0.03ng/ml). Secondary outcomes included prevalence of significant adverse events (AE) with ARN509 and operative complications following RP. Statistical significance was defined as p<0.05. RESULTS: Of the 30 subjects enrolled, 25 participants completed the study. The median age was 68 years, and serum PSA at recruitment was 11.6ng/mL. They comprised D-Amico intermediate-risk n=12 (48%) and high-risk n=13 (52%), with ISUP grade group distributions of 1(n=1, 4%), 2(n=13, 52%), 3(n=8, 32%) and 4-5(n=3, 12%). 84% of subjects achieved post-prostatectomy nadir PSA levels, and the rest achieved nadir PSA levels of 0.03-0.05. The post-therapy morphology classifications were group A (50%), group B (10%) and group C (40%). The median reduction of serum PSA after neoadjuvant apalutamide alone was 97.3% (range 61.2 to 100.0, p<0.0001). There was one subject with an unrelated grade III AE, and no subjects with Clavien-Dindo grade III and above surgical complications. CONCLUSIONS: Results of the phase II NEAR trial show safe and reasonable oncological outcomes in patients with organ confined prostate cancer. Source of Funding: This study is supported by Johnson & Johnson IIET Grant. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e1216-e1217 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information XinYan Yang* More articles by this author Edwin Jonathan Aslim More articles by this author Nye Thane Ngo More articles by this author Li Yan Khor More articles by this author Tsung Wen Chong More articles by this author John Shyi Peng Yuen More articles by this author Kae Jack Tay More articles by this author Henry Sun Sien Ho More articles by this author Lui Shiong Lee More articles by this author Expand All Advertisement PDF downloadLoading ...