Evidence map›Paper›PMID 35879722›Full record

Trial reportRadiation oncology (London, England)2022

Dose-escalated radiotherapy to 82 Gy for prostate cancer following insertion of a peri-rectal hydrogel spacer: 3-year outcomes from a phase II trial.

Andrew W See, Patrick Bowden, Geoffrey Wells, Sree Appu, Nathan Lawrentschuk, Peter Liodakis, Chloe Pandeli, Yolanda Aarons, Lloyd M L Smyth, Dean P McKenzie

Open access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Radiation oncology (London, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 2 countries.

Andrew W SeeIcon Cancer Centre, Richmond, Australia. Andrew.See@icon.team.
Patrick BowdenIcon Cancer Centre, Richmond, Australia.
Geoffrey WellsUrology Department, Eastern Health, Box Hill Hospital, Box Hill, Australia.
Sree AppuDepartment of Surgery, Monash University, Melbourne, Australia.
Nathan LawrentschukDivision of Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, Australia.
Peter LiodakisDepartment of Urology, Austin Health, Heidelberg, Australia.
Chloe PandeliIcon Cancer Centre, Richmond, Australia.
Yolanda AaronsIcon Cancer Centre, Richmond, Australia.
Lloyd M L SmythIcon Institute of Innovation and Research, South Brisbane, Australia.
Dean P McKenzieResearch Development and Governance Unit, Epworth HealthCare, Richmond, Australia.
Austin Health · AUCabrini Hospital · AUEastern Health · AUEpworth Hospital · AUIcon (Australia) · AUPeter MacCallum Cancer Centre · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDose-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.

methodsThis 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.

resultsSeventy 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.

conclusionsDose-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.

Indexed as

Prostatic NeoplasmsRadiotherapy, Intensity-ModulatedAustraliaHumansHydrogelsMaleProspective StudiesQuality of LifeRadiotherapy DosageRectumHydrogelsDose-escalationHydrogelProstate cancerRadiotherapyRectumToxicity

Identifiers

PMID35879722
PMCPMC9316359
OpenAlexW4287510005

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.