{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,26]],"date-time":"2026-01-26T16:23:47Z","timestamp":1769444627550,"version":"3.49.0"},"reference-count":43,"publisher":"Wiley","license":[{"start":{"date-parts":[[2022,9,28]],"date-time":"2022-09-28T00:00:00Z","timestamp":1664323200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research and Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"publisher"}]},{"name":"ASCO Young Investigator Award"},{"name":"Janssen Global Services, LLC"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Prostate Cancer"],"published-print":{"date-parts":[[2022,9,28]]},"abstract":"<jats:p>Purpose. This randomized phase 2 study sought to assess the treatment effect of a finite duration of apalutamide with and without androgen deprivation therapy (ADT) in biochemically recurrent prostate cancer (BCR PC). Materials and Methods. Patients with BCR PC after primary definitive therapy and prostate-specific antigen (PSA) doubling time \u226412 months were randomized to open-label apalutamide (240\u2009mg\/d) alone, apalutamide plus ADT, or ADT alone (1\u2009:\u20091:1 ratio) for 12 months followed by a 12-month observation period (NCT01790126). Mean changes from baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) at 12 months (primary endpoint) and other prespecified assessments of health-related quality of life (HRQoL), PSA nadir, time to PSA progression, time to testosterone recovery, recovered testosterone &gt;150\u2009ng\/dL without PSA progression at 24 months, and molecular markers were evaluated. Results. In 90 enrolled patients (apalutamide plus ADT (n\u2009=\u200931), apalutamide (n\u2009=\u200929), ADT (n\u2009=\u200930)), FACT-P at 12 months was not significantly different between apalutamide, ADT and apalutamide, and ADT groups. Addition of apalutamide to ADT prolonged time to PSA progression but this change did not reach statistical significance (hazard ratio (HR): 0.56, 95% confidence interval (CI): 0.23\u20131.36, <jats:inline-formula>\n                     <a:math xmlns:a=\"http:\/\/www.w3.org\/1998\/Math\/MathML\" id=\"M1\">\n                        <a:mi>P<\/a:mi>\n                        <a:mo>=<\/a:mo>\n                        <a:mn>0.196<\/a:mn>\n                     <\/a:math>\n                  <\/jats:inline-formula>); time to testosterone recovery was similar in the ADT-containing groups. In apalutamide plus ADT, apalutamide, and ADT groups, 37.9%, 37.0%, and 19.2% of patients, respectively, had testosterone &gt;150\u2009ng\/dL at 24 months without confirmed PSA progression. Of the few biomarkers expressed in blood, EPHA3 was significantly associated with shorter time to PSA progression (<jats:inline-formula>\n                     <c:math xmlns:c=\"http:\/\/www.w3.org\/1998\/Math\/MathML\" id=\"M2\">\n                        <c:mi>P<\/c:mi>\n                        <c:mo>=<\/c:mo>\n                        <c:mn>0.02<\/c:mn>\n                     <\/c:math>\n                  <\/jats:inline-formula>) in the overall population. Conclusions. HRQoL was similar in patients treated with apalutamide alone, ADT alone, or their combination, although apalutamide plus ADT did not demonstrate statistically significant noninferiority in change from baseline in overall HRQoL. The aggregated efficacy and safety outcomes support further evaluation of apalutamide plus ADT in BCR PC.<\/jats:p>","DOI":"10.1155\/2022\/5454727","type":"journal-article","created":{"date-parts":[[2022,9,29]],"date-time":"2022-09-29T01:50:10Z","timestamp":1664416210000},"page":"1-12","source":"Crossref","is-referenced-by-count":15,"title":["Randomized, Open-Label Phase 2 Study of Apalutamide plus Androgen Deprivation Therapy versus Apalutamide Monotherapy versus Androgen Deprivation Monotherapy in Patients with Biochemically Recurrent Prostate Cancer"],"prefix":"10.1155","volume":"2022","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7003-7982","authenticated-orcid":true,"given":"Rahul","family":"Aggarwal","sequence":"first","affiliation":[{"name":"Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joshi J.","family":"Alumkal","sequence":"additional","affiliation":[{"name":"Knight Cancer Institute, Oregon Health and Science University, Portland, OR, USA"},{"name":"Rogel Cancer Center, University of Michigan, Ann Arbor, MI, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Russell Z.","family":"Szmulewitz","sequence":"additional","affiliation":[{"name":"University of Chicago, Chicago, IL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Celestia S.","family":"Higano","sequence":"additional","affiliation":[{"name":"University of Washington, Fred Hutchinson Cancer Research Center, Seattle, WA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alan H.","family":"Bryce","sequence":"additional","affiliation":[{"name":"Mayo Clinic Arizona, Scottsdale, AZ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angela","family":"Lopez-Gitlitz","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, Los Angeles, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sharon A.","family":"McCarthy","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, Raritan, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Branko","family":"Miladinovic","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, San Diego, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kelly","family":"McQuarrie","sequence":"additional","affiliation":[{"name":"Merck, Rahway, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shibu","family":"Thomas","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, Spring House, PA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ke","family":"Zhang","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, San Diego, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric J.","family":"Small","sequence":"additional","affiliation":[{"name":"Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","reference":[{"key":"1","doi-asserted-by":"publisher","DOI":"10.1097\/ju.0000000000000117"},{"key":"2","first-page":"63","article-title":"Androgen deprivation therapy for prostate cancer: long-term safety and patient outcomes","volume":"5","author":"H. 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