Evidence map›Paper›PMID 34919884›Full record

Trial reportInternational journal of radiation oncology, biology, physics2022

Quality of Life Implications of Dose-Escalated External Beam Radiation for Localized Prostate Cancer: Results of a Prospective Randomized Phase 3 Clinical Trial, NRG/RTOG 0126.

William A Hall, Snehal Deshmukh, Deborah W Bruner, Jeff M Michalski, James A Purdy, Walter Bosch, Jean-Paul Bahary, Maltibehn P Patel, Matthew B Parliament, Michael I Lock and 12 more

Open access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.8field-weighted citation impact, top 14% 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

10 citing papers in PubMed, 17 citations in OpenAlex.

  1. Article
  2. Intensity modulated radiation therapy in prostate cancer-Better survival with higher total dose?Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 16 institutions in 2 countries.

William A HallFroedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin. Electronic address: whall@mcw.edu.
Snehal DeshmukhNRG Oncology Statistics and Data Management Center, American College of Radiology, Philadelphia, Pennsylvania.
Deborah W BrunerEmory University, Atlanta, Georgia.
Jeff M MichalskiWashington University School of Medicine, St. Louis, Missouri.
James A PurdyUniversity of California, Atlanata, Georgia.
Walter BoschWashington University School of Medicine, St. Louis, Missouri.
Jean-Paul BaharyCentre Hospitalier de l'Universite de Montreal, Montreal, Quebec.
Maltibehn P PatelJuravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada.
Matthew B ParliamentCross Cancer Institute, Edmonton, Alberta, Canada.
Michael I LockLondon Regional Cancer Program, London, Ontario, Canada.
Harold Y LauTom Baker Cancer Centre, Calgary, Alberta, Canada.
Luis SouhamiMcGill University, Montreal, Quebec.
Scot A FisherThomas Jefferson University Hospital, Philadelphia, Pennsylvania.
Young KwokUniversity of Maryland/Greenebaum Cancer Center, Baltimore, Maryland.
Michael J SeiderUniversity Hospitals Seidman Cancer Center, Cleveland, Ohio.
Eric VigneaultCHU de Quebec-L'Hotel-Dieu de Québec, Montreal, Quebec.
Seth A RosenthalSutter Cancer Centers Radiation Oncology Services-accruals under Radiologic Associates of Sacramento, Sacramento, California.
Gary S GustafsonBeaumont Health, Southfield, Michigan.
Hiram A GayWashington University School of Medicine, St. Louis, Missouri.
Stephanie L PughNRG Oncology Statistics and Data Management Center, American College of Radiology, Philadelphia, Pennsylvania.
Howard M SandlerCedars-Sinai Medical Center, Los Angeles, California.
Benjamin MovsasHenry Ford Cancer Institute, Detroit, Michigan.
Washington University in St. Louis · USAmerican College of Radiology · USAlberta Cancer Foundation · CABeaumont Health · USCedars-Sinai Medical Center · USCentre Hospitalier de l’Université de Montréal · CAEmory University · USFroedtert Hospital · USHenry Ford Hospital · USJuravinski Cancer Centre · CAMcGill University · CASutter Medical Center · USThomas Jefferson University Hospital · USUniversité du Québec à Montréal · CAUniversity Hospitals Seidman Cancer Center · USUniversity of Maryland, Baltimore · US

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
RTOG Foreign AccrualU10CA021661 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI CURRAN, WALTER J. · 1985 to 2013
$150.3M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam, GREG YOTHERS · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
RTOG Foreign AccrualsU10CA037422 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI BRUNER, DEBORAH WATKINS · 1985 to 2013
$30.4M
ADVANCED TECHNOLOGY QA CENTERU24CA081647 · NCI · WASHINGTON UNIVERSITY · PI MICHALSKI, JEFF M. · 1999 to 2013
$22.8M
WASHINGTON UNIVERSITY / SITEMAN CANCER CENTER LEAD ACADEMIC SITEUG1CA233339 · NCI · WASHINGTON UNIVERSITY · PI NANCY L BARTLETT, Clifford Grant Robinson · 2019 to 2026
$11.3M
NCI NIH HHS U10 CA021661NCI NIH HHS U10 CA037422NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS U24 CA081647NCI NIH HHS UG1 CA189867NCI NIH HHS UG1 CA233339
6 · The paper itself

Abstract

purposeExternal beam radiation therapy (EBRT) dose escalation has been tested in multiple prospective trials. However, the impact on patient reported outcomes (PROs) associated with higher doses of EBRT remain poorly understood. We sought to assess the differences in PROs between men treated with a dose of 70.2 Gy versus 79.2 Gy of EBRT for prostate cancer. METHODS AND MATERIALS: The phase 3 clinical trial RTOG 0126 randomized 1532 patients with prostate cancer between March 2002 and August 2008 to 79.2 Gy over 44 fractions versus 70.2 Gy over 39 fractions. Eligible patients participated in the PRO data collection. PROs completed included the International Index of Erectile Function Questionnaire (IIEF), Functional Alterations due to Changes in Elimination (FACE), and the Spitzer Quality of Life Index (SQLI). The timepoints for the IIEF were collected pre-entry and at 6, 12, and 24 months. The FACE and SQLI were collected pre-entry and at 3, 6, 12, 18, and 24 months. The impact of EBRT dose to normal structures (penile bulb, rectum, and bladder) on PROs was also examined. Mixed effects models were used to analyze trends across time.

resultsIn total, 1144 patients completed baseline IIEF forms and of these, 56%, 64%, and 61% completed the IIEF at 6, 12, and 24 months, respectively; 1123 patients completed the FACE score at baseline and 50%, 61%, 73%, 61%, and 65% completed all 15 items for the FACE metric at timepoints of 3, 6, 12, 18, and 24 months, respectively. Erectile dysfunction at 12 months based on the single question was not significantly different between arms (38.1% for the standard dose radiation therapy arm vs 49.7% for the dose escalated radiation therapy arm; P = .051). Treatment arm (70.2 vs 79.2) had no significant impact on any PRO metrics measured across all collected domains. Comprehensive dosimetric analyses are presented and reveal multiple significant differences to regional organs at risk.

conclusionsCompliance with PRO data collection was lower than anticipated in this phase 3 trial. Examining the available data, dose escalated EBRT did not appear to be associated with any detriment to PROs across numerous prospectively collected domains. These data, notwithstanding limitations, add to our understanding of the implications of EBRT dose escalation in prostate cancer. Furthermore, these results illustrate challenges associated with PRO data collection.

Indexed as

BrachytherapyProstatic NeoplasmsHumansMaleProspective StudiesQuality of LifeRadiotherapy Dosage

Identifiers

PMID34919884
PMCPMC8789217
OpenAlexW4200050779

What OpenQuestion holds

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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.