{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,18]],"date-time":"2026-03-18T01:20:57Z","timestamp":1773796857431,"version":"3.50.1"},"reference-count":26,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2020,3,11]],"date-time":"2020-03-11T00:00:00Z","timestamp":1583884800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008050","name":"Fundaci\u00f3n Cellex","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008050","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2020,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>To present the 18\u00a0months results from a prospective multicenter phase II randomized trial of short vs protracted urethra\u2010sparing stereotactic body radiotherapy (SBRT) for localized prostate cancer (PCa).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Between 2012 and 2015, a total of 170 PCa patients were randomized to 36.25\u00a0Gy in 5 fractions (6.5\u00a0Gy\u00a0\u00d7\u00a05 to the urethra) delivered either every other day (EOD, arm A, n\u00a0=\u00a084) or once a week (QW, arm B, n\u00a0=\u00a086). Genitourinary (GU) and gastrointestinal (GI) toxicity (CTCAE v4.0 scale), IPSS, and QoL scores were assessed at baseline, at the 5th fraction (5fx), 12th weeks (12W), and every 6\u00a0months after SBRT. The primary endpoint was biochemical control at 18\u00a0months and grade\u00a0\u2265\u00a03 toxicity (including grade\u00a0\u2265\u00a02 for urinary obstruction\/retention) during the first 3\u00a0months.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among the 165 patients analyzed, the toxicity stopping rule was never activated during the acute phase. Maximum acute grade 2 GU toxicity rates at 5fx were 17% and 19% for arms A and B, respectively, with only 2 cases of grade 2 GI toxicity at 5fx in arm A. At month 18, grade\u00a0\u2265\u00a02 GU and GI toxicity decreased below 5% and 2% for both arms. No changes in EORTC QLQ\u2010PR25 scores for GU, GI, and sexual domains were observed in both arms between baseline and month 18. Four biochemical failures were observed, 2 in each arm, rejecting the null hypothesis of an unfavorable response rate\u00a0\u2264\u00a085% in favor of an acceptable\u00a0\u2265\u00a095% rate.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>At 18\u00a0months, urethra\u2010sparing SBRT showed a low toxicity profile, with minimal impact on QoL and favorable biochemical control rates, regardless of overall treatment time (EOD vs QW).<\/jats:p><\/jats:sec>","DOI":"10.1002\/cam4.2966","type":"journal-article","created":{"date-parts":[[2020,3,11]],"date-time":"2020-03-11T18:07:30Z","timestamp":1583950050000},"page":"3097-3106","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":41,"title":["Once\u2010a\u2010week or every\u2010other\u2010day urethra\u2010sparing prostate cancer stereotactic body radiotherapy, a randomized phase II trial: 18 months follow\u2010up 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