Evidence map›Paper›PMID 27044935›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2016

Randomized Phase III Noninferiority Study Comparing Two Radiotherapy Fractionation Schedules in Patients With Low-Risk Prostate Cancer.

W Robert Lee, James J Dignam, Mahul B Amin, Deborah W Bruner, Daniel Low, Gregory P Swanson, Amit B Shah, David P D'Souza, Jeff M Michalski, Ian S Dayes and 9 more

6 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 304 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
304citing papers in PubMed, 11 pooled it
54.8field-weighted citation impact, top 1% 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.

NCT00331773 phase3completednot on this map

A Phase III Randomized Study of Hypofractionated 3D-CRT/MRT Versus Conventionally Fractionated 3D-CRT/MRT in Patients With Favorable-Risk Prostate Cancer

TypeinterventionalSponsorRadiation Therapy Oncology GroupRan2006 to 2022Enrolled1,116ConditionsProstate CancerArmsConventional 3D-CRT or IMRT, Hypofractionated 3D-CRT or IMRT
NCT03254420 naactive not recruitingnot on this map

Randomized Phase II Study Evaluating Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins. (RCMIGI)

TypeinterventionalSponsorInstitut du Cancer de Montpellier - Val d'AurelleRan2016 to 2028Enrolled74ConditionsProstate CancerArmsCalypso beacon implant, moderate hypofractionation Radiotherapy
NCT04004312 narecruitingnot on this mapstarted 2018, after this paper: background citation

Single Fractions SBRT in the Treatment of Prostate Cancer: A Phase I Study

TypeinterventionalSponsorFabio CuryRan2018 to 2027Enrolled12ConditionsProstate CancerArmsStereotactic Body Radiation Therapy (SBRT)
NCT05936736 narecruitingnot on this mapstarted 2023, after this paper: background citation

24 Gy in One Fraction Urethral-sparing "High-Dose-Rate Like" Stereotactic Body RadioTherapy for Prostate Cancer: a Single-center Non-randomized Prospective Clinical Study (PRO-FAST)

TypeinterventionalSponsorIRCCS San RaffaeleRan2023 to 2030Enrolled70ConditionsLocalized Prostate CarcinomaArmsprostate SBRT
NCT06027892 narecruitingnot on this mapstarted 2022, after this paper: background citation

Two-fraction Versus Five-fraction Stereotactic Radiotherapy for Localized Low- and Favorable Intermediate-risk Prostate Cancer: SABR-Dual

TypeinterventionalSponsorRabin Medical CenterRan2022 to 2032Enrolled562ConditionsPROSTATE CANCERArmsTwo-fraction stereotactic radiotherapy, Five-fraction stereotactic radiotherapy
NCT06546267 recruitingnot on this mapstarted 2022, after this paper: background citation

Efficacy of Advanced Radiotherapy (ART) in Prostate Cancer Patients With Early Stage, Advanced, Metastatic and Relapsed Disease (PROST-ART)

TypeobservationalSponsorIRCCS San RaffaeleRan2022 to 2027Enrolled2,500ConditionsProstate CancerArmsImage Guided Radiotherapy, Intensity Modulated Radiotherapy, Stereotactic Body Radiotherapy
3 · Its place in the literature

Who cites it

304 citing papers in PubMed, 11 syntheses or guidelines pooled it, 620 citations in OpenAlex.

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  11. Diminishing Returns From Ultrahypofractionated Radiation Therapy for Prostate Cancer.International journal of radiation oncology, biology, physics · 2020
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244 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 1 institution in 1 country.

W Robert LeeW. Robert Lee and Bridget F. Koontz, Duke University Medical Center, Durham, NC; James J. Dignam, University of Chicago, Chicago, IL; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center; Daniel Low, University of California, Los Angeles, Los Angeles; Samantha A. Seaward, Kaiser Permanente Northern California, Santa Clara, CA; Deborah W. Bruner, Emory University, Atlanta, GA; Gregory P. Swanson, Baylor Scott & White Healthcare Temple Clinic, Temple, TX; Amit B. Shah, York Cancer Center, York; James J. Dignam and Rebecca Paulus, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; David P. D'Souza, London Regional Cancer Program, London, Ontario; Ian S. Dayes, McMaster University, Hamilton, Ontario; Sergio L. Faria, McGill University Health Center, Montreal, Quebec, Canada; Jeff M. Michalski, Washington University School of Medicine, St Louis, MO; William A. Hall, Medical College of Wisconsin, Milwaukee, WI; Paul L. Nguyen, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA; Thomas M. Pisansky, Mayo Clinic, Rochester, MN; and Yuhchyau Chen, University of Rochester, Rochester, NY. w.robert.lee@duke.edu.
James J DignamW. Robert Lee and Bridget F. Koontz, Duke University Medical Center, Durham, NC; James J. Dignam, University of Chicago, Chicago, IL; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center; Daniel Low, University of California, Los Angeles, Los Angeles; Samantha A. Seaward, Kaiser Permanente Northern California, Santa Clara, CA; Deborah W. Bruner, Emory University, Atlanta, GA; Gregory P. Swanson, Baylor Scott & White Healthcare Temple Clinic, Temple, TX; Amit B. Shah, York Cancer Center, York; James J. Dignam and Rebecca Paulus, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; David P. D'Souza, London Regional Cancer Program, London, Ontario; Ian S. Dayes, McMaster University, Hamilton, Ontario; Sergio L. Faria, McGill University Health Center, Montreal, Quebec, Canada; Jeff M. Michalski, Washington University School of Medicine, St Louis, MO; William A. Hall, Medical College of Wisconsin, Milwaukee, WI; Paul L. Nguyen, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA; Thomas M. Pisansky, Mayo Clinic, Rochester, MN; and Yuhchyau Chen, University of Rochester, Rochester, NY.
Mahul B AminW. Robert Lee and Bridget F. Koontz, Duke University Medical Center, Durham, NC; James J. Dignam, University of Chicago, Chicago, IL; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center; Daniel Low, University of California, Los Angeles, Los Angeles; Samantha A. Seaward, Kaiser Permanente Northern California, Santa Clara, CA; Deborah W. Bruner, Emory University, Atlanta, GA; Gregory P. Swanson, Baylor Scott & White Healthcare Temple Clinic, Temple, TX; Amit B. Shah, York Cancer Center, York; James J. Dignam and Rebecca Paulus, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; David P. D'Souza, London Regional Cancer Program, London, Ontario; Ian S. Dayes, McMaster University, Hamilton, Ontario; Sergio L. Faria, McGill University Health Center, Montreal, Quebec, Canada; Jeff M. Michalski, Washington University School of Medicine, St Louis, MO; William A. Hall, Medical College of Wisconsin, Milwaukee, WI; Paul L. Nguyen, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA; Thomas M. Pisansky, Mayo Clinic, Rochester, MN; and Yuhchyau Chen, University of Rochester, Rochester, NY.
Deborah W BrunerW. Robert Lee and Bridget F. Koontz, Duke University Medical Center, Durham, NC; James J. Dignam, University of Chicago, Chicago, IL; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center; Daniel Low, University of California, Los Angeles, Los Angeles; Samantha A. Seaward, Kaiser Permanente Northern California, Santa Clara, CA; Deborah W. Bruner, Emory University, Atlanta, GA; Gregory P. Swanson, Baylor Scott & White Healthcare Temple Clinic, Temple, TX; Amit B. Shah, York Cancer Center, York; James J. Dignam and Rebecca Paulus, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; David P. D'Souza, London Regional Cancer Program, London, Ontario; Ian S. Dayes, McMaster University, Hamilton, Ontario; Sergio L. Faria, McGill University Health Center, Montreal, Quebec, Canada; Jeff M. Michalski, Washington University School of Medicine, St Louis, MO; William A. Hall, Medical College of Wisconsin, Milwaukee, WI; Paul L. Nguyen, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA; Thomas M. Pisansky, Mayo Clinic, Rochester, MN; and Yuhchyau Chen, University of Rochester, Rochester, NY.
Daniel LowW. Robert Lee and Bridget F. Koontz, Duke University Medical Center, Durham, NC; James J. Dignam, University of Chicago, Chicago, IL; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center; Daniel Low, University of California, Los Angeles, Los Angeles; Samantha A. Seaward, Kaiser Permanente Northern California, Santa Clara, CA; Deborah W. Bruner, Emory University, Atlanta, GA; Gregory P. Swanson, Baylor Scott & White Healthcare Temple Clinic, Temple, TX; Amit B. Shah, York Cancer Center, York; James J. Dignam and Rebecca Paulus, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; David P. D'Souza, London Regional Cancer Program, London, Ontario; Ian S. Dayes, McMaster University, Hamilton, Ontario; Sergio L. Faria, McGill University Health Center, Montreal, Quebec, Canada; Jeff M. Michalski, Washington University School of Medicine, St Louis, MO; William A. Hall, Medical College of Wisconsin, Milwaukee, WI; Paul L. Nguyen, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA; Thomas M. Pisansky, Mayo Clinic, Rochester, MN; and Yuhchyau Chen, University of Rochester, Rochester, NY.
Gregory P SwansonW. Robert Lee and Bridget F. Koontz, Duke University Medical Center, Durham, NC; James J. Dignam, University of Chicago, Chicago, IL; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center; Daniel Low, University of California, Los Angeles, Los Angeles; Samantha A. Seaward, Kaiser Permanente Northern California, Santa Clara, CA; Deborah W. Bruner, Emory University, Atlanta, GA; Gregory P. Swanson, Baylor Scott & White Healthcare Temple Clinic, Temple, TX; Amit B. Shah, York Cancer Center, York; James J. Dignam and Rebecca Paulus, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; David P. D'Souza, London Regional Cancer Program, London, Ontario; Ian S. Dayes, McMaster University, Hamilton, Ontario; Sergio L. Faria, McGill University Health Center, Montreal, Quebec, Canada; Jeff M. Michalski, Washington University School of Medicine, St Louis, MO; William A. Hall, Medical College of Wisconsin, Milwaukee, WI; Paul L. Nguyen, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA; Thomas M. Pisansky, Mayo Clinic, Rochester, MN; and Yuhchyau Chen, University of Rochester, Rochester, NY.
Amit B ShahW. Robert Lee and Bridget F. Koontz, Duke University Medical Center, Durham, NC; James J. Dignam, University of Chicago, Chicago, IL; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center; Daniel Low, University of California, Los Angeles, Los Angeles; Samantha A. Seaward, Kaiser Permanente Northern California, Santa Clara, CA; Deborah W. Bruner, Emory University, Atlanta, GA; Gregory P. Swanson, Baylor Scott & White Healthcare Temple Clinic, Temple, TX; Amit B. Shah, York Cancer Center, York; James J. Dignam and Rebecca Paulus, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; David P. D'Souza, London Regional Cancer Program, London, Ontario; Ian S. Dayes, McMaster University, Hamilton, Ontario; Sergio L. Faria, McGill University Health Center, Montreal, Quebec, Canada; Jeff M. Michalski, Washington University School of Medicine, St Louis, MO; William A. Hall, Medical College of Wisconsin, Milwaukee, WI; Paul L. Nguyen, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA; Thomas M. Pisansky, Mayo Clinic, Rochester, MN; and Yuhchyau Chen, University of Rochester, Rochester, NY.
David P D'SouzaW. Robert Lee and Bridget F. Koontz, Duke University Medical Center, Durham, NC; James J. Dignam, University of Chicago, Chicago, IL; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center; Daniel Low, University of California, Los Angeles, Los Angeles; Samantha A. Seaward, Kaiser Permanente Northern California, Santa Clara, CA; Deborah W. Bruner, Emory University, Atlanta, GA; Gregory P. Swanson, Baylor Scott & White Healthcare Temple Clinic, Temple, TX; Amit B. Shah, York Cancer Center, York; James J. Dignam and Rebecca Paulus, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; David P. D'Souza, London Regional Cancer Program, London, Ontario; Ian S. Dayes, McMaster University, Hamilton, Ontario; Sergio L. Faria, McGill University Health Center, Montreal, Quebec, Canada; Jeff M. Michalski, Washington University School of Medicine, St Louis, MO; William A. Hall, Medical College of Wisconsin, Milwaukee, WI; Paul L. Nguyen, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA; Thomas M. Pisansky, Mayo Clinic, Rochester, MN; and Yuhchyau Chen, University of Rochester, Rochester, NY.
Jeff M MichalskiW. Robert Lee and Bridget F. Koontz, Duke University Medical Center, Durham, NC; James J. Dignam, University of Chicago, Chicago, IL; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center; Daniel Low, University of California, Los Angeles, Los Angeles; Samantha A. Seaward, Kaiser Permanente Northern California, Santa Clara, CA; Deborah W. Bruner, Emory University, Atlanta, GA; Gregory P. Swanson, Baylor Scott & White Healthcare Temple Clinic, Temple, TX; Amit B. Shah, York Cancer Center, York; James J. Dignam and Rebecca Paulus, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; David P. D'Souza, London Regional Cancer Program, London, Ontario; Ian S. Dayes, McMaster University, Hamilton, Ontario; Sergio L. Faria, McGill University Health Center, Montreal, Quebec, Canada; Jeff M. Michalski, Washington University School of Medicine, St Louis, MO; William A. Hall, Medical College of Wisconsin, Milwaukee, WI; Paul L. Nguyen, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA; Thomas M. Pisansky, Mayo Clinic, Rochester, MN; and Yuhchyau Chen, University of Rochester, Rochester, NY.
Ian S DayesW. Robert Lee and Bridget F. Koontz, Duke University Medical Center, Durham, NC; James J. Dignam, University of Chicago, Chicago, IL; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center; Daniel Low, University of California, Los Angeles, Los Angeles; Samantha A. Seaward, Kaiser Permanente Northern California, Santa Clara, CA; Deborah W. Bruner, Emory University, Atlanta, GA; Gregory P. Swanson, Baylor Scott & White Healthcare Temple Clinic, Temple, TX; Amit B. Shah, York Cancer Center, York; James J. Dignam and Rebecca Paulus, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; David P. D'Souza, London Regional Cancer Program, London, Ontario; Ian S. Dayes, McMaster University, Hamilton, Ontario; Sergio L. Faria, McGill University Health Center, Montreal, Quebec, Canada; Jeff M. Michalski, Washington University School of Medicine, St Louis, MO; William A. Hall, Medical College of Wisconsin, Milwaukee, WI; Paul L. Nguyen, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA; Thomas M. Pisansky, Mayo Clinic, Rochester, MN; and Yuhchyau Chen, University of Rochester, Rochester, NY.
Samantha A SeawardW. Robert Lee and Bridget F. Koontz, Duke University Medical Center, Durham, NC; James J. Dignam, University of Chicago, Chicago, IL; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center; Daniel Low, University of California, Los Angeles, Los Angeles; Samantha A. Seaward, Kaiser Permanente Northern California, Santa Clara, CA; Deborah W. Bruner, Emory University, Atlanta, GA; Gregory P. Swanson, Baylor Scott & White Healthcare Temple Clinic, Temple, TX; Amit B. Shah, York Cancer Center, York; James J. Dignam and Rebecca Paulus, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; David P. D'Souza, London Regional Cancer Program, London, Ontario; Ian S. Dayes, McMaster University, Hamilton, Ontario; Sergio L. Faria, McGill University Health Center, Montreal, Quebec, Canada; Jeff M. Michalski, Washington University School of Medicine, St Louis, MO; William A. Hall, Medical College of Wisconsin, Milwaukee, WI; Paul L. Nguyen, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA; Thomas M. Pisansky, Mayo Clinic, Rochester, MN; and Yuhchyau Chen, University of Rochester, Rochester, NY.
William A HallW. Robert Lee and Bridget F. Koontz, Duke University Medical Center, Durham, NC; James J. Dignam, University of Chicago, Chicago, IL; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center; Daniel Low, University of California, Los Angeles, Los Angeles; Samantha A. Seaward, Kaiser Permanente Northern California, Santa Clara, CA; Deborah W. Bruner, Emory University, Atlanta, GA; Gregory P. Swanson, Baylor Scott & White Healthcare Temple Clinic, Temple, TX; Amit B. Shah, York Cancer Center, York; James J. Dignam and Rebecca Paulus, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; David P. D'Souza, London Regional Cancer Program, London, Ontario; Ian S. Dayes, McMaster University, Hamilton, Ontario; Sergio L. Faria, McGill University Health Center, Montreal, Quebec, Canada; Jeff M. Michalski, Washington University School of Medicine, St Louis, MO; William A. Hall, Medical College of Wisconsin, Milwaukee, WI; Paul L. Nguyen, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA; Thomas M. Pisansky, Mayo Clinic, Rochester, MN; and Yuhchyau Chen, University of Rochester, Rochester, NY.
Paul L NguyenW. Robert Lee and Bridget F. Koontz, Duke University Medical Center, Durham, NC; James J. Dignam, University of Chicago, Chicago, IL; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center; Daniel Low, University of California, Los Angeles, Los Angeles; Samantha A. Seaward, Kaiser Permanente Northern California, Santa Clara, CA; Deborah W. Bruner, Emory University, Atlanta, GA; Gregory P. Swanson, Baylor Scott & White Healthcare Temple Clinic, Temple, TX; Amit B. Shah, York Cancer Center, York; James J. Dignam and Rebecca Paulus, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; David P. D'Souza, London Regional Cancer Program, London, Ontario; Ian S. Dayes, McMaster University, Hamilton, Ontario; Sergio L. Faria, McGill University Health Center, Montreal, Quebec, Canada; Jeff M. Michalski, Washington University School of Medicine, St Louis, MO; William A. Hall, Medical College of Wisconsin, Milwaukee, WI; Paul L. Nguyen, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA; Thomas M. Pisansky, Mayo Clinic, Rochester, MN; and Yuhchyau Chen, University of Rochester, Rochester, NY.
Thomas M PisanskyW. Robert Lee and Bridget F. Koontz, Duke University Medical Center, Durham, NC; James J. Dignam, University of Chicago, Chicago, IL; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center; Daniel Low, University of California, Los Angeles, Los Angeles; Samantha A. Seaward, Kaiser Permanente Northern California, Santa Clara, CA; Deborah W. Bruner, Emory University, Atlanta, GA; Gregory P. Swanson, Baylor Scott & White Healthcare Temple Clinic, Temple, TX; Amit B. Shah, York Cancer Center, York; James J. Dignam and Rebecca Paulus, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; David P. D'Souza, London Regional Cancer Program, London, Ontario; Ian S. Dayes, McMaster University, Hamilton, Ontario; Sergio L. Faria, McGill University Health Center, Montreal, Quebec, Canada; Jeff M. Michalski, Washington University School of Medicine, St Louis, MO; William A. Hall, Medical College of Wisconsin, Milwaukee, WI; Paul L. Nguyen, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA; Thomas M. Pisansky, Mayo Clinic, Rochester, MN; and Yuhchyau Chen, University of Rochester, Rochester, NY.
Sergio L FariaW. Robert Lee and Bridget F. Koontz, Duke University Medical Center, Durham, NC; James J. Dignam, University of Chicago, Chicago, IL; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center; Daniel Low, University of California, Los Angeles, Los Angeles; Samantha A. Seaward, Kaiser Permanente Northern California, Santa Clara, CA; Deborah W. Bruner, Emory University, Atlanta, GA; Gregory P. Swanson, Baylor Scott & White Healthcare Temple Clinic, Temple, TX; Amit B. Shah, York Cancer Center, York; James J. Dignam and Rebecca Paulus, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; David P. D'Souza, London Regional Cancer Program, London, Ontario; Ian S. Dayes, McMaster University, Hamilton, Ontario; Sergio L. Faria, McGill University Health Center, Montreal, Quebec, Canada; Jeff M. Michalski, Washington University School of Medicine, St Louis, MO; William A. Hall, Medical College of Wisconsin, Milwaukee, WI; Paul L. Nguyen, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA; Thomas M. Pisansky, Mayo Clinic, Rochester, MN; and Yuhchyau Chen, University of Rochester, Rochester, NY.
Yuhchyau ChenW. Robert Lee and Bridget F. Koontz, Duke University Medical Center, Durham, NC; James J. Dignam, University of Chicago, Chicago, IL; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center; Daniel Low, University of California, Los Angeles, Los Angeles; Samantha A. Seaward, Kaiser Permanente Northern California, Santa Clara, CA; Deborah W. Bruner, Emory University, Atlanta, GA; Gregory P. Swanson, Baylor Scott & White Healthcare Temple Clinic, Temple, TX; Amit B. Shah, York Cancer Center, York; James J. Dignam and Rebecca Paulus, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; David P. D'Souza, London Regional Cancer Program, London, Ontario; Ian S. Dayes, McMaster University, Hamilton, Ontario; Sergio L. Faria, McGill University Health Center, Montreal, Quebec, Canada; Jeff M. Michalski, Washington University School of Medicine, St Louis, MO; William A. Hall, Medical College of Wisconsin, Milwaukee, WI; Paul L. Nguyen, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA; Thomas M. Pisansky, Mayo Clinic, Rochester, MN; and Yuhchyau Chen, University of Rochester, Rochester, NY.
Bridget F KoontzW. Robert Lee and Bridget F. Koontz, Duke University Medical Center, Durham, NC; James J. Dignam, University of Chicago, Chicago, IL; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center; Daniel Low, University of California, Los Angeles, Los Angeles; Samantha A. Seaward, Kaiser Permanente Northern California, Santa Clara, CA; Deborah W. Bruner, Emory University, Atlanta, GA; Gregory P. Swanson, Baylor Scott & White Healthcare Temple Clinic, Temple, TX; Amit B. Shah, York Cancer Center, York; James J. Dignam and Rebecca Paulus, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; David P. D'Souza, London Regional Cancer Program, London, Ontario; Ian S. Dayes, McMaster University, Hamilton, Ontario; Sergio L. Faria, McGill University Health Center, Montreal, Quebec, Canada; Jeff M. Michalski, Washington University School of Medicine, St Louis, MO; William A. Hall, Medical College of Wisconsin, Milwaukee, WI; Paul L. Nguyen, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA; Thomas M. Pisansky, Mayo Clinic, Rochester, MN; and Yuhchyau Chen, University of Rochester, Rochester, NY.
Rebecca PaulusW. Robert Lee and Bridget F. Koontz, Duke University Medical Center, Durham, NC; James J. Dignam, University of Chicago, Chicago, IL; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center; Daniel Low, University of California, Los Angeles, Los Angeles; Samantha A. Seaward, Kaiser Permanente Northern California, Santa Clara, CA; Deborah W. Bruner, Emory University, Atlanta, GA; Gregory P. Swanson, Baylor Scott & White Healthcare Temple Clinic, Temple, TX; Amit B. Shah, York Cancer Center, York; James J. Dignam and Rebecca Paulus, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; David P. D'Souza, London Regional Cancer Program, London, Ontario; Ian S. Dayes, McMaster University, Hamilton, Ontario; Sergio L. Faria, McGill University Health Center, Montreal, Quebec, Canada; Jeff M. Michalski, Washington University School of Medicine, St Louis, MO; William A. Hall, Medical College of Wisconsin, Milwaukee, WI; Paul L. Nguyen, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA; Thomas M. Pisansky, Mayo Clinic, Rochester, MN; and Yuhchyau Chen, University of Rochester, Rochester, NY.
Howard M SandlerW. Robert Lee and Bridget F. Koontz, Duke University Medical Center, Durham, NC; James J. Dignam, University of Chicago, Chicago, IL; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center; Daniel Low, University of California, Los Angeles, Los Angeles; Samantha A. Seaward, Kaiser Permanente Northern California, Santa Clara, CA; Deborah W. Bruner, Emory University, Atlanta, GA; Gregory P. Swanson, Baylor Scott & White Healthcare Temple Clinic, Temple, TX; Amit B. Shah, York Cancer Center, York; James J. Dignam and Rebecca Paulus, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; David P. D'Souza, London Regional Cancer Program, London, Ontario; Ian S. Dayes, McMaster University, Hamilton, Ontario; Sergio L. Faria, McGill University Health Center, Montreal, Quebec, Canada; Jeff M. Michalski, Washington University School of Medicine, St Louis, MO; William A. Hall, Medical College of Wisconsin, Milwaukee, WI; Paul L. Nguyen, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA; Thomas M. Pisansky, Mayo Clinic, Rochester, MN; and Yuhchyau Chen, University of Rochester, Rochester, NY.
Los Angeles Medical Center · 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 Mei-Yin C Polley · 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
NCI NIH HHS U10 CA021661NCI NIH HHS U10 CA037422NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS U24 CA081647NCI NIH HHS UG1 CA189867
6 · The paper itself

Abstract

purposeConventional radiotherapy (C-RT) treatment schedules for patients with prostate cancer typically require 40 to 45 treatments that take place from > 8 to 9 weeks. Preclinical and clinical research suggest that hypofractionation-fewer treatments but at a higher dose per treatment-may produce similar outcomes. This trial was designed to assess whether the efficacy of a hypofractionated radiotherapy (H-RT) treatment schedule is no worse than a C-RT schedule in men with low-risk prostate cancer. PATIENTS AND

methodsA total of 1,115 men with low-risk prostate cancer were randomly assigned 1:1 to C-RT (73.8 Gy in 41 fractions over 8.2 weeks) or to H-RT (70 Gy in 28 fractions over 5.6 weeks). This trial was designed to establish (with 90% power and an α of .05) that treatment with H-RT results in 5-year disease-free survival (DFS) that is not worse than C-RT by more than 7.65% (H-RT/C-RT hazard ratio [HR] < 1.52).

resultsA total of 1,092 men were protocol eligible and had follow-up information; 542 patients were assigned to C-RT and 550 to H-RT. Median follow-up was 5.8 years. Baseline characteristics were not different according to treatment assignment. The estimated 5-year DFS was 85.3% (95% CI, 81.9 to 88.1) in the C-RT arm and 86.3% (95% CI, 83.1 to 89.0) in the H-RT arm. The DFS HR was 0.85 (95% CI, 0.64 to 1.14), and the predefined noninferiority criterion that required that DFS outcomes be consistent with HR < 1.52 was met (P < .001). Late grade 2 and 3 GI and genitourinary adverse events were increased (HR, 1.31 to 1.59) in patients who were treated with H-RT.

conclusionIn men with low-risk prostate cancer, the efficacy of 70 Gy in 28 fractions over 5.6 weeks is not inferior to 73.8 Gy in 41 fractions over 8.2 weeks, although an increase in late GI/genitourinary adverse events was observed in patients treated with H-RT.

Indexed as

Dose Fractionation, RadiationAdultAgedHumansMaleMiddle AgedProstatic NeoplasmsRadiation Injuries

Identifiers

PMID27044935
PMCPMC4981980
OpenAlexW2337386322

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Registered trials

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.