Evidence map›Paper›PMID 39894025›Full record

SynthesisThe Lancet. Oncology2025

The interplay between acute and late toxicity among patients receiving prostate radiotherapy: an individual patient data meta-analysis of six randomised trials.

John Nikitas, Parsa Jamshidian, Alison C Tree, Emma Hall, David Dearnaley, Jeff M Michalski, W Robert Lee, Paul L Nguyen, Howard M Sandler, Charles N Catton and 18 more

Abstract readMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in The Lancet. Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
–field-weighted citation impact
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

16 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

John NikitasDepartment of Radiation Oncology, University of California, Los Angeles, Los Angeles, CA, USA; Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA, USA.
Parsa JamshidianDepartment of Biostatistics, University of California, Los Angeles, Los Angeles, CA, USA.
Alison C TreeInstitute of Cancer Research, London, UK; The Royal Marsden NHS Foundation Trust, Sutton, UK.
Emma HallInstitute of Cancer Research, London, UK.
David DearnaleyInstitute of Cancer Research, London, UK; The Royal Marsden NHS Foundation Trust, Sutton, UK.
Jeff M MichalskiDepartment of Radiation Oncology, Washington University School of Medicine, St. Louis, MO, USA.
W Robert LeeDepartment of Radiation Oncology, Duke University, Durham, NC, USA.
Paul L NguyenDepartment of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA, USA.
Howard M SandlerDepartment of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Charles N CattonDepartment of Radiation Oncology, Princess Margaret Cancer Centre and University of Toronto, Toronto, ON, Canada.
Himanshu R LukkaJuravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON, Canada.
Luca IncrocciDepartment of Radiotherapy, Erasmus Medical Center, Rotterdam, Netherlands.
Wilma HeemsbergenDepartment of Radiotherapy, Erasmus Medical Center, Rotterdam, Netherlands.
Floris J PosDepartment of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, Netherlands.
Soumyajit RoyDepartment of Radiation Oncology, Rush University Medical Center, Chicago, IL, USA; Department of Radiation Oncology, University Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, OH, USA.
Shawn MaloneDepartment of Radiology, Radiation Oncology and Medical Physics, University of Ottawa, Ottawa, ON, Canada.
Eric HorwitzDepartment of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.
Jessica Karen WongDepartment of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.
Stefano ArcangeliDepartment of Medicine and Surgery, University of Milan Bicocca, Milan, Italy.
Giuseppe SanguinetiDepartment of Radiation Oncology, IRCCS Regina Elena National Cancer Institute, Rome, Italy.
Tahmineh RomeroDepartment of Medicine Statistical Core, University of California, Los Angeles, Los Angeles, CA, USA.
Yilun SunDepartment of Radiation Oncology, University Hospitals Seidman Cancer Center, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Michael L SteinbergDepartment of Radiation Oncology, University of California, Los Angeles, Los Angeles, CA, USA.
Luca F ValleDepartment of Radiation Oncology, University of California, Los Angeles, Los Angeles, CA, USA; Greater Los Angeles VA Medical Center, Los Angeles, CA, USA.
Joanne B WeidhaasDepartment of Radiation Oncology, University of California, Los Angeles, Los Angeles, CA, USA.
Daniel SprattDepartment of Radiation Oncology, University Hospitals Seidman Cancer Center, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Donatello TelescaDepartment of Biostatistics, University of California, Los Angeles, Los Angeles, CA, USA.
Amar U KishanDepartment of Radiation Oncology, University of California, Los Angeles, Los Angeles, CA, USA. Electronic address: aukishan@mednet.ucla.edu.

Funding

Integrative Cancer Scholars Training GrantT32CA009213 · NCI · UNIVERSITY OF ARIZONA · PI CAREW, JENNIFER S, CURIEL-LEWANDROWSKI, CLARA · 1985 to 2024
$8.6M
Reducing toxicity from prostate cancer radiotherapy through genetics and technologyR37CA292795 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Amar U Kishan · 2024 to 2026
$1.1M
NCI NIH HHS R37 CA292795NCI NIH HHS T32 CA009213
6 · The paper itself

Abstract

backgroundThe association between acute and late toxicity following prostate radiotherapy has not been well studied using data from multiple randomised clinical trials and fractionation schedules. We aimed to characterise the relationship between acute and late genitourinary and gastrointestinal toxicity among patients receiving conventionally fractionated or moderately hypofractionated prostate radiotherapy.

methodsThis was an individual patient data meta-analysis that identified randomised phase 3 trials of conventionally fractionated or moderately hypofractionated prostate radiotherapy in the Meta-Analysis of Randomized trials in Cancer of the Prostate (MARCAP) Consortium that had individual-level acute and late toxicity data available and were available before Dec 1, 2023. Trials without individual patient data were excluded. Data were provided to MARCAP by study investigators. The associations between acute (≤3 months after radiotherapy) and late (>3 months after radiotherapy) grade 2 or greater genitourinary and gastrointestinal toxicities were assessed using adjusted generalised linear mixed models (adjusted for age, androgen deprivation therapy status, type of radiotherapy, radiation dose, and radiation schedule). In the subset of trials that collected Expanded Prostate Cancer Index Composite quality of life (QOL) evaluations, the association between acute genitourinary and gastrointestinal toxicity and decrements at least twice the minimal clinically important difference (MCID) for urinary and bowel QOL were also evaluated.

findingsSix of 26 available trials met all the eligibility criteria. 6593 patients were included (conventionally fractionated: n=4248; moderately hypofractionated: n=2345). Median follow-up was 72 months (IQR 61-94). Acute grade 2 or greater genitourinary toxicity was associated with both late grade 2 or greater genitourinary toxicity (odds ratio 2·20 [95% CI 1·88-2·57], p<0·0001) and decrement at least twice the MCID in urinary QOL (1·41 [1·17-1·68], p=0·0002). Acute grade 2 or greater gastrointestinal toxicity was associated with both late grade 2 or greater gastrointestinal toxicity (2·53 [2·07-3·08], p<0·0001) and decrement at least twice the MCID in bowel QOL (1·52 [1·26-1·83], p<0·0001).

interpretationAcute toxicity following prostate radiotherapy was statistically significantly associated with late toxicity and with decrement in patient-reported QOL metrics. These data support efforts to evaluate whether interventions that reduce acute toxicity ultimately reduce the risk of late toxicity.

fundingNational Institutes of Health and US Department of Defense.

Indexed as

Prostatic NeoplasmsRadiation InjuriesAgedClinical Trials, Phase III as TopicGastrointestinal DiseasesHumansMaleMiddle AgedRadiation Dose HypofractionationRandomized Controlled Trials as TopicTime Factors

Identifiers

PMID39894025
PMCPMC12875763

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.