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dc.contributor.authorWestley, RL
dc.contributor.authorBiscombe, K
dc.contributor.authorDunlop, A
dc.contributor.authorMitchell, A
dc.contributor.authorOelfke, U
dc.contributor.authorNill, S
dc.contributor.authorMurray, J
dc.contributor.authorPathmanathan, A
dc.contributor.authorHafeez, S
dc.contributor.authorParker, C
dc.contributor.authorRatnakumaran, R
dc.contributor.authorAlexander, S
dc.contributor.authorHerbert, T
dc.contributor.authorHall, E
dc.contributor.authorTree, AC
dc.coverage.spatialUnited States
dc.identifier.citationInternational Journal of Radiation: Oncology - Biology - Physics, 2023, pp. S0360-3016(23)07949-X -
dc.description.abstractPURPOSE: Ultrahypofractionated radiation therapy (UHRT) is an effective treatment for localized prostate cancer with an acceptable toxicity profile; boosting the visible intraprostatic tumor has been shown to improve biochemical disease-free survival with no significant effect on genitourinary (GU) and gastrointestinal (GI) toxicity. METHODS AND MATERIALS: HERMES is a single-center noncomparative randomized phase 2 trial in men with intermediate or lower high risk prostate cancer. Patients were allocated (1:1) to 36.25 Gy in 5 fractions over 2 weeks or 24 Gy in 2 fractions over 8 days with an integrated boost to the magnetic resonance imaging (MRI) visible tumor of 27 Gy in 2 fractions. A minimization algorithm with a random element with risk group as a balancing factor was used for participant randomization. Treatment was delivered on the Unity MR-Linac (Elekta AB) with daily online adaption. The primary endpoint was acute GU Common Terminology Criteria for Adverse Events version 5.0 toxicity with the aim of excluding a doubling of the rate of acute grade 2+ GU toxicity seen in PACE. Analysis was by treatment received and included all participants who received at least 1 fraction of study treatment. This interim analysis was prespecified (stage 1 of a 2-stage Simon design) for when 10 participants in each treatment group had completed the acute toxicity monitoring period (12 weeks after radiation therapy). RESULTS: Acute grade 2 GU toxicity was reported in 1 (10%) patient in the 5-fraction group and 2 (20%) patients in the 2-fraction group. No grade 3+ GU toxicities were reported. CONCLUSIONS: At this interim analysis, the rate of GU toxicity in the 2-fraction and 5-fraction treatment groups was found to be below the prespecified threshold (5/10 grade 2+) and continuation of the study to complete recruitment of 23 participants per group was recommended.
dc.format.extentS0360-3016(23)07949-X -
dc.publisherElsevier BV
dc.relation.ispartofInternational Journal of Radiation: Oncology - Biology - Physics
dc.titleInterim Toxicity Analysis From the Randomized HERMES Trial of 2- and 5-Fraction Magnetic Resonance Imaging-Guided Adaptive Prostate Radiation Therapy.
dc.typeJournal Article
rioxxterms.typeJournal Article/Review
pubs.organisational-groupICR/Primary Group
pubs.organisational-groupICR/Primary Group/ICR Divisions
pubs.organisational-groupICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-groupICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit
pubs.organisational-groupICR/Primary Group/ICR Divisions/Radiotherapy and Imaging
pubs.organisational-groupICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Radiotherapy Physics Modelling
pubs.organisational-groupICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Clinical Academic Radiotherapy (Huddart)
pubs.organisational-groupICR/Primary Group/Royal Marsden Clinical Units
pubs.organisational-groupICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Uro-oncology Clinical Trials
pubs.organisational-groupICR/Students/MD(Res)/Starting Cohort 20/21
pubs.publication-statusPublished online
icr.researchteamUro-oncology Trials
icr.researchteamClin Trials & Stats Unit
icr.researchteamRadiother Phys Modelling
icr.researchteamClinic Acad RT Huddart
dc.contributor.icrauthorWestley, Rosalyne
dc.contributor.icrauthorBiscombe, Katie
dc.contributor.icrauthorNill, Simeon
dc.contributor.icrauthorHafeez, Shaista
dc.contributor.icrauthorHall, Emma
icr.provenanceDeposited by Mrs Jessica Perry (impersonating Prof Emma Hall) on 2023-11-14. Deposit type is initial. No. of files: 1. Files: Interim Toxicity Analysis From the Randomized HERMES Trial of 2- and 5-Fraction Magnetic Resonance Imaging–Guided Adaptive Prostate Radiation Therapy.pdf

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