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Continued Benefit to Rectal Separation for Prostate Radiation Therapy: Final Results of a Phase III Trial Daniel A. Hamstra, MD, PhD, Neil Mariados, MD, John Sylvester, MD, Dhiren Shah, MD, Lawrence Karsh, MD, Richard Hudes, MD, David Beyer, MD, Steven Kurtzman, MD, Jeffrey Bogart, MD, R. Alex Hsi, MD, Michael Kos, MD, Rodney Ellis, MD, Mark Logsdon, MD, Shawn Zimberg, MD, Kevin Forsythe, MD, Hong Zhang, MD, PhD, Edward Soffen, MD, Patrick Francke, MD, Constantine Mantz, MD, Peter Rossi, MD, Theodore DeWeese, MD, Stephanie Daignault-Newton, MS, Benjamin W. Fischer-Valuck, MD, Anupama Chundury, MD, Hiram Gay, MD, Walter Bosch, DSc, Jeff Michalski, MD, MBA International Journal of Radiation Oncology • Biology • Physics Volume 97, Issue 5, Pages (April 2017) DOI: /j.ijrobp Copyright © 2017 The Authors Terms and Conditions
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Fig. 1 Radiation dosimetry to rectum (A) and penile bulb (B) as a function of treatment arm. Doses presented as the mean ± standard error of the mean. Abbreviations: Dmax = maximum dose; pV(x) = the percentage of penile bulb at or above “x” Gy. International Journal of Radiation Oncology • Biology • Physics , DOI: ( /j.ijrobp ) Copyright © 2017 The Authors Terms and Conditions
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Fig. 2 The cumulative incidence of grade ≥1 (A) and ≥2 (B) bowel toxicity and grade ≥1 urinary incontinence (C) and grade ≥2 urinary toxicity (D). Abbreviations: CI = confidence interval; HR = hazard ratio. International Journal of Radiation Oncology • Biology • Physics , DOI: ( /j.ijrobp ) Copyright © 2017 The Authors Terms and Conditions
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Fig. 3 Mean changes in bowel quality of life summary score (A) as a function of treatment arm. Data presented as mean ± standard error of the mean. The proportion of patients with detectable changes in bowel quality of life at the 5-point (B) or 10-point (C) threshold. Abbreviations: CI = confidence interval; MID = minimally important difference; OR = odds ratio. International Journal of Radiation Oncology • Biology • Physics , DOI: ( /j.ijrobp ) Copyright © 2017 The Authors Terms and Conditions
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Fig. 4 Mean changes in urinary quality of life summary score (A) as a function of treatment arm. Data presented as mean ± standard error of the mean. The proportion of patients with detectable changes in bowel quality of life at the 6-point (B) or 12-point (C) threshold. Abbreviations: CI = confidence interval; MID = minimally important difference; OR = odds ratio. International Journal of Radiation Oncology • Biology • Physics , DOI: ( /j.ijrobp ) Copyright © 2017 The Authors Terms and Conditions
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Fig. 5 The proportion of patients by treatment arm with changes across all 3 quality of life domains (bowel, urinary, and sexual) at the 1× (A, B) or 2× (C, D) thresholds. The overlaps between circles show patients with declines in 2 or 3 domains. Abbreviation: MID = minimally important difference. International Journal of Radiation Oncology • Biology • Physics , DOI: ( /j.ijrobp ) Copyright © 2017 The Authors Terms and Conditions
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Figure E1 International Journal of Radiation Oncology • Biology • Physics , DOI: ( /j.ijrobp ) Copyright © 2017 The Authors Terms and Conditions
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Figure E2 International Journal of Radiation Oncology • Biology • Physics , DOI: ( /j.ijrobp ) Copyright © 2017 The Authors Terms and Conditions
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Figure E3 International Journal of Radiation Oncology • Biology • Physics , DOI: ( /j.ijrobp ) Copyright © 2017 The Authors Terms and Conditions
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Figure E4 International Journal of Radiation Oncology • Biology • Physics , DOI: ( /j.ijrobp ) Copyright © 2017 The Authors Terms and Conditions
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Figure E5 International Journal of Radiation Oncology • Biology • Physics , DOI: ( /j.ijrobp ) Copyright © 2017 The Authors Terms and Conditions
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Table E1 International Journal of Radiation Oncology • Biology • Physics , DOI: ( /j.ijrobp ) Copyright © 2017 The Authors Terms and Conditions
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Table E2 International Journal of Radiation Oncology • Biology • Physics , DOI: ( /j.ijrobp ) Copyright © 2017 The Authors Terms and Conditions
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Table E3 International Journal of Radiation Oncology • Biology • Physics , DOI: ( /j.ijrobp ) Copyright © 2017 The Authors Terms and Conditions
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Table E4 International Journal of Radiation Oncology • Biology • Physics , DOI: ( /j.ijrobp ) Copyright © 2017 The Authors Terms and Conditions
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Table E5 International Journal of Radiation Oncology • Biology • Physics , DOI: ( /j.ijrobp ) Copyright © 2017 The Authors Terms and Conditions
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Table E6 International Journal of Radiation Oncology • Biology • Physics , DOI: ( /j.ijrobp ) Copyright © 2017 The Authors Terms and Conditions
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Table E7 International Journal of Radiation Oncology • Biology • Physics , DOI: ( /j.ijrobp ) Copyright © 2017 The Authors Terms and Conditions
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Table E8 International Journal of Radiation Oncology • Biology • Physics , DOI: ( /j.ijrobp ) Copyright © 2017 The Authors Terms and Conditions
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