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dc.contributor.authorSee, Andrew W-
dc.contributor.authorBowden, Patrick-
dc.contributor.authorWells, Geoffrey-
dc.contributor.authorAppu, Sree-
dc.contributor.authorLawrentschuk, Nathan-
dc.contributor.authorLiodakis, Peter-
dc.contributor.authorPandeli, Chloe-
dc.contributor.authorAarons, Yolanda-
dc.contributor.authorSmyth, Lloyd M L-
dc.contributor.authorMcKenzie, Dean P-
dc.identifier.citationRadiation oncology (London, England) 2022-07-25; 17(1): 131en
dc.description.abstractDose-escalation to above 80 Gy during external beam radiotherapy for localised prostate cancer leads to improved oncological outcomes but also substantially increased rectal toxicity. The aim of this study was to demonstrate the safety and efficacy of escalating the dose to 82 Gy following insertion of a peri-rectal hydrogel spacer (HS) prior to radiotherapy. This was a single arm, open-label, prospective study of men with localised prostate cancer who were prescribed a course of intensity modulated radiotherapy escalated to 82 Gy in 2 Gy fractions following insertion of the SpaceOAR™ HS (Boston Scientific, Marlborough, MA). Patients were prescribed a standard course of 78 Gy in 2 Gy fractions where rectal dose constraints could not be met for the 82 Gy plan. The co-primary endpoints were the rate of grade 3 gastrointestinal (GI) and genitourinary (GU) adverse events (CTCAE, v4), and patient-reported quality of life (QoL) (EORTC QLQ-C30 and PR25 modules), up to 37.5 months post-treatment. Seventy patients received treatment on the study, with 64 (91.4%) receiving an 82 Gy treatment course. The median follow-up time post-treatment was 37.4 months. The rate of radiotherapy-related grade 3 GI and GU adverse events was 0% and 2.9%, respectively. There were 2 (2.9%) grade 3 adverse events related to insertion of the HS. Only small and transient declines in QoL were observed; there was no clinically or statistically significant decline in QoL beyond 13.5 months and up to 37.5 months post-treatment, compared to baseline. No late RTOG-defined grade ≥ 2 GI toxicity was observed, with no GI toxicity observed in any patient at 37.5 months post-treatment. Nine (12.9%) patients met criteria for biochemical failure within the follow-up period. Dose-escalation to 82 Gy, facilitated by use of a hydrogel spacer, is safe and feasible, with minimal toxicity up to 37.5 months post-treatment when compared to rates of rectal toxicity in previous dose-escalation trials up to 80 Gy. Trials with longer follow-up of oncological and functional outcomes are required to robustly demonstrate a sustained widening of the therapeutic window. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12621000056897 , 22/01/2021. Retrospectively registered.en
dc.subjectProstate canceren
dc.titleDose-escalated radiotherapy to 82 Gy for prostate cancer following insertion of a peri-rectal hydrogel spacer: 3-year outcomes from a phase II trial.en
dc.typeJournal Articleen
dc.identifier.journaltitleRadiation oncology (London, England)en
dc.identifier.affiliationCabrini Health, Malvern, Australiaen
dc.identifier.affiliationDepartment of Urology, Austin Health, Heidelberg, Australiaen
dc.identifier.affiliationIcon Cancer Centre, Richmond, Australia.en
dc.identifier.affiliationEJ Whitten Centre for Prostate Cancer Research, Epworth Healthcare, Melbourne, Australiaen
dc.identifier.affiliationDivision of Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, Australiaen
dc.identifier.affiliationDepartment of Urology, Royal Melbourne Hospital, Melbourne, Australiaen
dc.identifier.affiliationDepartment of Surgery, University of Melbourne, Melbourne, Australiaen
dc.identifier.affiliationIcon Cancer Centre, Richmond, Australiaen
dc.identifier.affiliationIcon Institute of Innovation and Research, South Brisbane, Australiaen
dc.identifier.affiliationResearch Development and Governance Unit, Epworth HealthCare, Richmond, Australiaen
dc.identifier.affiliationDepartment of Health Sciences and Biostatistics, Swinburne University of Technology, Hawthorn, Australiaen
dc.identifier.affiliationUrology Department, Eastern Health, Box Hill Hospital, Box Hill, Australiaen
dc.identifier.affiliationDepartment of Surgery, Monash University, Melbourne, Australiaen
dc.identifier.affiliationNorth Eastern Urology, Heidelberg, Australiaen
dc.identifier.pubmedid35879722, Peter
item.fulltextNo Fulltext-
item.openairetypeJournal Article-
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