{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T10:04:52Z","timestamp":1793786692594,"version":"4.6.1"},"reference-count":30,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2022,1,28]],"date-time":"2022-01-28T00:00:00Z","timestamp":1643328000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,1,28]],"date-time":"2022-01-28T00:00:00Z","timestamp":1643328000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100001349","name":"MOH | National Medical Research Council","doi-asserted-by":"publisher","award":["NMRC\/CSA-INV\/0027\/2018"],"award-info":[{"award-number":["NMRC\/CSA-INV\/0027\/2018"]}],"id":[{"id":"10.13039\/501100001349","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001349","name":"MOH | National Medical Research Council","doi-asserted-by":"publisher","award":["MOH-000248"],"award-info":[{"award-number":["MOH-000248"]}],"id":[{"id":"10.13039\/501100001349","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001381","name":"National Research Foundation Singapore","doi-asserted-by":"publisher","award":["NRF-CRP17-2017-05"],"award-info":[{"award-number":["NRF-CRP17-2017-05"]}],"id":[{"id":"10.13039\/501100001381","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001459","name":"Ministry of Education - Singapore","doi-asserted-by":"publisher","award":["MOE2016-T3-1-004"],"award-info":[{"award-number":["MOE2016-T3-1-004"]}],"id":[{"id":"10.13039\/501100001459","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100012023","name":"National Cancer Centre of Singapore","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100012023","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100016017","name":"Duke-NUS Medical School","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100016017","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Sengkang General Hospital"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Prostate Cancer Prostatic Dis"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Objective<\/jats:title>\n                <jats:p>Treatment efficacy of androgen deprivation therapy with radical prostatectomy for intermediate- to high-risk prostate cancer is less well-studied. The NEAR trial is a single-arm, phase II investigation of neoadjuvant apalutamide monotherapy and radical prostatectomy (RP) in the treatment of D\u2019Amico intermediate- and high-risk prostate cancer (NCT03124433).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Materials and methods<\/jats:title>\n                <jats:p>Patients with histologically-proven, D\u2019Amico intermediate- to high-risk prostate adenocarcinoma received apalutamide 240\u2009mg once-daily for 12 weeks followed by RP\u2009+\u2009\/\u2212lymphadenectomy. Primary outcome was pathological complete response (pCR) rate. Secondary outcomes included rate of biochemical response (defined by PSA\u2009&lt;\u20090.03\u2009ng\/mL at week 24 from starting apalutamide without subsequent PSA relapse), treatment-related adverse events, and RP complication rates. Correlative biomarker analyses were performed to examine for molecular predictors of treatment responses.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>From 2017 to 2019, 30 patients were recruited, of which 20 and 10 were high and intermediate risk, respectively; 25 completed treatment as per-protocol. We did not observe any pCR on trial; median reduction of cancer burden was 41.7% (IQR: 33.3%\u201360.0%). 18 out of 25 patients were classified as having a biochemical response (4 did not achieve PSA of &lt;0.03\u2009ng\/mL at week 24 and 3 developed PSA relapse subsequently). Dry skin (<jats:italic>N<\/jats:italic>\u2009=\u200916; 53.3%), fatigue (<jats:italic>N<\/jats:italic>\u2009=\u200910; 33.3%) and skin rash (<jats:italic>N<\/jats:italic>\u2009=\u20099; 30.0%) were the most common adverse events, and there was no major peri-operative complication. We observed an association between tumours of low androgen receptor activity and PAM50 basal status with biochemical non-responders, albeit these molecular phenotypes were not associated with pathological response.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>A 12-week course of neoadjuvant apalutamide prior to RP did not meet the primary endpoint of pCR in this trial. Tumours with low androgen receptor activity or of the PAM50 basal subtype may have a reduced response to apalutamide.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1038\/s41391-022-00496-8","type":"journal-article","created":{"date-parts":[[2022,1,28]],"date-time":"2022-01-28T12:06:11Z","timestamp":1643371571000},"page":"741-748","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["NEAR trial: A single-arm phase II trial of neoadjuvant apalutamide monotherapy and radical prostatectomy in intermediate- and high-risk prostate cancer"],"prefix":"10.1038","volume":"25","author":[{"given":"Lui Shiong","family":"Lee","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adelene Y. 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S.","family":"Lim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1512-3356","authenticated-orcid":false,"given":"Edwin Jonathan","family":"Aslim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2419-0817","authenticated-orcid":false,"given":"Nye-Thane","family":"Ngo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li-Yan","family":"Khor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ravindran","family":"Kanesvaran","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John Carson Jr","family":"Allen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0365-1899","authenticated-orcid":false,"given":"Kae Jack","family":"Tay","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John Shyi Peng","family":"Yuen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tsung Wen","family":"Chong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sun Sien Henry","family":"Ho","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bin Tean","family":"Teh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1648-1473","authenticated-orcid":false,"given":"Melvin L. 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MLKC reports personal fees from Astellas, Janssen, Bayer, Pfizer, MSD, personal fees and non-financial support from AstraZeneca, personal fees and grants from Ferring, personal fees and non-financial support from Varian, non-financial support from Decipher Biosciences, non-financial support from MedLever, non-financial support from EVYD Technology, and consults for immunoSCAPE Inc., outside the submitted work. RK received honorarium from ad hoc medical advisory boards for Janssen, Astellas, BMS, MSD, Bayer, Ferring, Amgen, Pfizer, Novartis, AstraZaneca, Eisai, and Ipsen.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}