Evaluation of Hypofractionated Radiation Therapy Use and Patient-Reported Outcomes in Men With Nonmetastatic Prostate Cancer in Australia and New Zealand

Pryor, David; Martin, Jarad; Millar, Jeremy; Day, Heather; Ong, Wee Loon; Skala, Marketa; FitzGerald, Liesel M.; Hindson, Ben; Higgs, Braden; O’Callaghan, Michael; Syed, Farhan; Hayden, Alix; Turner, Sandra; Papa, Nathan

doi:10.1001/jamanetworkopen.2021.29647

Cited by 14 publications

(22 citation statements)

References 27 publications

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“…Given that HFRT has been associated with greater acute grade 2 or higher GI toxic effects than CFRT, 7,12 rectal spacing may address a clinically important need for the large volume of patients receiving this effective and convenient treatment. 2 The acute grade 2 or higher GI toxic effect rates observed in this study are consistent with prior literature. For the spacer group, the 2.9% rate of acute grade 2 or higher toxic effects was similar to the 2.8% rate observed in a phase 1 study involving an HA spacer before HFRT.…”

Section: Discussionsupporting

confidence: 92%

Hyaluronic Acid Spacer for Hypofractionated Prostate Radiation Therapy

et al. 2023

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ImportanceHypofractionated radiation therapy (RT) for prostate cancer has been associated with greater acute grade 2 gastrointestinal (GI) toxic effects compared with conventionally fractionated RT.ObjectiveTo evaluate whether a hyaluronic acid rectal spacer could (1) improve rectal dosimetry and (2) affect acute grade 2 or higher GI toxic effects for hypofractionated RT.Design, Setting, and ParticipantsThis randomized clinical trial was conducted from March 2020 to June 2021 among 12 centers within the US, Australia, and Spain, with a 6-month follow-up. Adult patients with biopsy-proven, T1 to T2 prostate cancer with a Gleason score 7 or less and prostate-specific antigen level of 20 ng/mL or less (to convert to μg/L, multiply by 1) were blinded to the treatment arms. Of the 260 consented patients, 201 patients (77.3%) were randomized (2:1) to the presence or absence of the spacer. Patients were stratified by intended 4-month androgen deprivation therapy use and erectile quality.Main Outcomes and MeasuresFor the primary outcome, we hypothesized that more than 70% of patients in the spacer group would achieve a 25% or greater reduction in the rectal volume receiving 54 Gy (V54). For the secondary outcome, we hypothesized that the spacer group would have noninferior acute (within 3 months) grade 2 or higher GI toxic effects compared with the control group, with a margin of 10%.ResultsOf the 201 randomized patients, 8 (4.0%) were Asian, 26 (12.9%) Black, 42 (20.9%) Hispanic or Latino, and 153 (76.1%) White; the mean (SD) age for the spacer group was 68.6 (7.2) years and 68.4 (7.3) years for the control group. For the primary outcome, 131 of 133 (98.5%; 95% CI, 94.7%-99.8%) patients in the spacer group experienced a 25% or greater reduction in rectum V54, which was greater than the minimally acceptable 70% (P &lt; .001). The mean (SD) reduction was 85.0% (20.9%). For the secondary outcome, 4 of 136 patients (2.9%) in the spacer group and 9 of 65 patients (13.8%) in the control group experienced acute grade 2 or higher GI toxic effects (difference, −10.9%; 95% 1-sided upper confidence limit, −3.5; P = .01).Conclusions and RelevanceThe trial results suggest that rectal spacing with hyaluronic acid improved rectal dosimetry and reduced acute grade 2 or higher GI toxic effects. Rectal spacing should potentially be considered for minimizing the risk of acute grade 2 or higher toxic effects for hypofractionated RT.Trial RegistrationClinicalTrials.gov Identifier: NCT04189913

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Section: Discussionsupporting

confidence: 92%

Hyaluronic Acid Spacer for Hypofractionated Prostate Radiation Therapy

et al. 2023

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“…However, current funding within PCOR-Vic has limited PRO collection up to 12 months post-treatment, and future funding is required to allow assessment of longer-term follow-up for men enrolled in PCOR-Vic. There are varying dose-fractionation schedules used for EBRT component which may confound the PRO; however, previous Australian population-based study has shown no clinically significant difference in PRO between men treated with conventional fractionated and hypofractionated EBRT [38] .…”

Section: Discussionmentioning

confidence: 99%

Real-world utilisation of brachytherapy boost and patient-reported functional outcomes in men who had external beam radiation therapy for prostate cancer in Australia

Ong

Evans

Papa

et al. 2022

Clinical and Translational Radiation Oncology

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“…Although local dashboards for both healthcare professionals and patients may provide patients’ individual PRO outcomes, the availability of aggregated reference data will considerably improve local dashboard information by showing patients their health status compared to the mean outcomes of other patients with MM. Additionally, analyses of aggregated data will be useful to evaluate the quality of MM care through benchmark meetings, providing insights into what matters most to patients and what improvements are required in clinical practice [ 32 – 34 ]. To provide reliable aggregated outcome information, large amounts of data are needed.…”

Section: Discussionmentioning

confidence: 99%