{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T12:41:16Z","timestamp":1789821676760,"version":"4.0.1"},"reference-count":16,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2022,9,29]],"date-time":"2022-09-29T00:00:00Z","timestamp":1664409600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2023,4]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess, the effect of darolutamide (a structurally distinct androgen receptor inhibitor) on urinary and bowel symptoms,  using data from the phase III ARAMIS trial (NCT02200614) that showed darolutamide significantly reduced the risk of metastasis and death versus placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Methods<\/jats:title>\n                    <jats:p>\n                      Patients with non\u2010metastatic castration\u2010resistant prostate cancer (nmCRPC) were randomised 2:1 to darolutamide (\n                      <jats:italic>n<\/jats:italic>\n                      =\u2009955) or placebo (\n                      <jats:italic>n<\/jats:italic>\n                      =\u2009554). Local symptom control was assessed by first prostate cancer\u2010related invasive procedures and post hoc analyses of time to deterioration in quality of life (QoL) using total urinary and bowel symptoms, and individual questions for these symptoms from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Prostate Cancer Module subscales and Functional Assessment of Cancer Therapy\u2010Prostate prostate cancer subscale. Prostate\u2010specific antigen (PSA) responses were correlated with urinary and bowel adverse events (AEs).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Fewer patients receiving darolutamide (4.7%) versus placebo (9.6%) underwent invasive procedures, and time to first procedure was prolonged with darolutamide (hazard ratio 0.42, 95% confidence interval 0.28\u20130.62). Darolutamide significantly (\n                      <jats:italic>P<\/jats:italic>\n                      &lt;\u20090.01) delayed worsening of QoL for total urinary and bowel symptoms versus placebo, mostly attributed by individual symptoms of urinary frequency, associated pain, and interference with daily activities. AEs of urinary retention and dysuria were less frequent with darolutamide, and greater PSA response (\u226590%, \u226550% and &lt;90%, &lt;50%) among darolutamide\u2010treated patients was associated with lower incidences of urinary retention (2.2%, 4.2%, 5.1%) and dysuria (0.5%, 3.2%, 5.1%), respectively.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Darolutamide demonstrated a positive impact on local disease recurrence and symptom control in patients with nmCRPC, delayed time to deterioration in QoL related to urinary and bowel symptoms, and a favourable safety profile showing similar incidence of urinary\u2010 and bowel\u2010related AEs compared with placebo.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bju.15887","type":"journal-article","created":{"date-parts":[[2022,9,10]],"date-time":"2022-09-10T09:49:02Z","timestamp":1662803342000},"page":"452-460","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Impact of darolutamide on local symptoms: pre\u2010planned and post hoc analyses of the\n                    <scp>ARAMIS<\/scp>\n                    trial"],"prefix":"10.1111","volume":"131","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5767-0548","authenticated-orcid":false,"given":"Neal D.","family":"Shore","sequence":"first","affiliation":[{"name":"Carolina Urologic Research Center Atlantic Urology Clinics  Myrtle Beach SC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4207-9928","authenticated-orcid":false,"given":"Arnulf","family":"Stenzl","sequence":"additional","affiliation":[{"name":"Clinic for Urology T\u00fcbingen  T\u00fcbingen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Pieczonka","sequence":"additional","affiliation":[{"name":"Associated Medical Professionals  Syracuse NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zachary","family":"Klaassen","sequence":"additional","affiliation":[{"name":"Georgia Cancer Center  Augusta GA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William J.","family":"Aronson","sequence":"additional","affiliation":[{"name":"University of California and VA Medical Center Greater Los Angeles Healthcare System  Los Angeles CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence","family":"Karsh","sequence":"additional","affiliation":[{"name":"The Urology Center of Colorado  Denver CO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles J.","family":"Ryan","sequence":"additional","affiliation":[{"name":"University of Minnesota  Minneapolis MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jorge","family":"Ortiz","sequence":"additional","affiliation":[{"name":"Bayer Healthcare  Whippany NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shankar","family":"Srinivasan","sequence":"additional","affiliation":[{"name":"Bayer Healthcare  Whippany NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ateesha F.","family":"Mohamed","sequence":"additional","affiliation":[{"name":"Bayer Healthcare  Whippany NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"Verholen","sequence":"additional","affiliation":[{"name":"Bayer Consumer Care AG  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,9,29]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41391-020-00310-3"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40271-017-0227-y"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.01.529"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.25762"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00345-016-1803-9"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1815671"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1038\/srep12007"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11523-019-00674-0"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2001342"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1097\/JU.0000000000001767"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2008.07.030"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-4733.2008.00409.x"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2021.06.010"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.MLR.0000062554.74615.4C"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.esmoop.2021.100089"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1743-9191(13)60028-X"}],"container-title":["BJU International"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bju.15887","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/bju.15887","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bjui-journals.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bju.15887","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T10:22:43Z","timestamp":1761733363000},"score":1,"resource":{"primary":{"URL":"https:\/\/bjui-journals.onlinelibrary.wiley.com\/doi\/10.1111\/bju.15887"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,9,29]]},"references-count":16,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2023,4]]}},"alternative-id":["10.1111\/bju.15887"],"URL":"https:\/\/doi.org\/10.1111\/bju.15887","archive":["Portico"],"relation":{},"ISSN":["1464-4096","1464-410X"],"issn-type":[{"value":"1464-4096","type":"print"},{"value":"1464-410X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,9,29]]},"assertion":[{"value":"2022-09-29","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}