{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T18:48:05Z","timestamp":1790102885807,"version":"4.0.1"},"reference-count":31,"publisher":"Oxford University Press (OUP)","issue":"1124","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["BJR"],"published-print":{"date-parts":[[2021,8,1]]},"abstract":"<jats:sec><jats:title>Objectives:<\/jats:title><jats:p> The present multicenter Phase II study evaluated the rate of late grade \u22652 gastrointestinal (GI) toxicities at 3 years, after hypofractionated radiotherapy (HFR) of prostate cancer with injection of hyaluronic acid (HA) between the prostate and the rectum. <\/jats:p><\/jats:sec><jats:sec><jats:title>Methods:<\/jats:title><jats:p> Between 2010 and 2013, 36 patients with low- or intermediate-risk prostate cancer were treated by HFR\/IMRT-IGRT. 20 fractions of 3.1\u2009Gy were delivered, 5 days per week for a total dose of 62\u2009Gy. A transperineal injection of 10cc of HA was performed between the rectum and the prostate. Late toxicities were evaluated between 3 and 36 months after the end of treatment (CTCAE v4). <\/jats:p><\/jats:sec><jats:sec><jats:title>Results:<\/jats:title><jats:p> Median pretreatment prostate-specific antigen was 8\u2009ng\u2009ml<jats:sup>\u22121<\/jats:sup>. Among the 36 included patients, 2 were not evaluated because they withdrew the study in the first 3 months of follow-up, and 4 withdrew between 3 and 36 months, the per protocol population was therefore composed. Late grade \u22652\u2009GI toxicities occurred in 4 (12%) patients with 3 (9%) Grade 2 rectal bleedings and one diarrhoea. Therefore, the inefficacy hypothesis following Fleming one-stage design cannot be rejected. None of the patients experienced late Grade 3\u20134 toxicities. Among the 30 patients completing the 36 months\u2019 visit, none still had a grade \u22652\u2009GI toxicity. Late grade \u22652 genitourinary (GU) toxicities occurred in 14 (41%) patients. The most frequent toxicities were dysuria and pollakiuria. Four patients still experienced a grade \u22652\u2009GU toxicity at 36 months. The biochemical relapse rate (nadir +2\u2009ng\u2009ml<jats:sup>\u22121<\/jats:sup>) was 6% (2 patients). Overall, HA was very well tolerated with no pain or discomfort. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion:<\/jats:title><jats:p> Despite the inefficacy of HA injection was not rejected, we observed the absence of Grade 3 or 4 rectal toxicity as well as a rate of Grade 2 rectal bleeding below 10% at 36 months of follow-up. Late urinary toxicities are the most frequent but the rate decreases largely at 3 years. <\/jats:p><\/jats:sec><jats:sec><jats:title>Advances in knowledge:<\/jats:title><jats:p> With an injection of HA, hypofractionated irradiation in 4 weeks is well tolerated with no Grade 3 or 4\u2009GI toxicity and a rate of Grade 2 rectal bleeding below 10% at 36 months of follow-up. <\/jats:p><\/jats:sec>","DOI":"10.1259\/bjr.20210242","type":"journal-article","created":{"date-parts":[[2021,7,20]],"date-time":"2021-07-20T12:45:52Z","timestamp":1626785152000},"source":"Crossref","is-referenced-by-count":8,"title":["Prostate hypofractionated radiotherapy (62Gy at 3.1Gy per fraction) with injection of hyaluronic acid: final results of the RPAH1 study"],"prefix":"10.1093","volume":"94","author":[{"given":"Olivier","family":"Chapet","sequence":"first","affiliation":[{"name":"Hospices Civils de Lyon, Lyon, France"},{"name":"Universit\u00e9 Lyon 1, Lyon, 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