Continued Benefit to Rectal Separation for Prostate Radiation Therapy: Final Results of a Phase III Trial Daniel A. Hamstra, MD, PhD, Neil Mariados,

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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 976-985 (April 2017) DOI: 10.1016/j.ijrobp.2016.12.024 Copyright © 2017 The Authors Terms and Conditions

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 2017 97, 976-985DOI: (10.1016/j.ijrobp.2016.12.024) Copyright © 2017 The Authors Terms and Conditions

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 2017 97, 976-985DOI: (10.1016/j.ijrobp.2016.12.024) Copyright © 2017 The Authors Terms and Conditions

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 2017 97, 976-985DOI: (10.1016/j.ijrobp.2016.12.024) Copyright © 2017 The Authors Terms and Conditions

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 2017 97, 976-985DOI: (10.1016/j.ijrobp.2016.12.024) Copyright © 2017 The Authors Terms and Conditions

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 2017 97, 976-985DOI: (10.1016/j.ijrobp.2016.12.024) Copyright © 2017 The Authors Terms and Conditions

Figure E1 International Journal of Radiation Oncology • Biology • Physics 2017 97, 976-985DOI: (10.1016/j.ijrobp.2016.12.024) Copyright © 2017 The Authors Terms and Conditions

Figure E2 International Journal of Radiation Oncology • Biology • Physics 2017 97, 976-985DOI: (10.1016/j.ijrobp.2016.12.024) Copyright © 2017 The Authors Terms and Conditions

Figure E3 International Journal of Radiation Oncology • Biology • Physics 2017 97, 976-985DOI: (10.1016/j.ijrobp.2016.12.024) Copyright © 2017 The Authors Terms and Conditions

Figure E4 International Journal of Radiation Oncology • Biology • Physics 2017 97, 976-985DOI: (10.1016/j.ijrobp.2016.12.024) Copyright © 2017 The Authors Terms and Conditions

Figure E5 International Journal of Radiation Oncology • Biology • Physics 2017 97, 976-985DOI: (10.1016/j.ijrobp.2016.12.024) Copyright © 2017 The Authors Terms and Conditions

Table E1 International Journal of Radiation Oncology • Biology • Physics 2017 97, 976-985DOI: (10.1016/j.ijrobp.2016.12.024) Copyright © 2017 The Authors Terms and Conditions

Table E2 International Journal of Radiation Oncology • Biology • Physics 2017 97, 976-985DOI: (10.1016/j.ijrobp.2016.12.024) Copyright © 2017 The Authors Terms and Conditions

Table E3 International Journal of Radiation Oncology • Biology • Physics 2017 97, 976-985DOI: (10.1016/j.ijrobp.2016.12.024) Copyright © 2017 The Authors Terms and Conditions

Table E4 International Journal of Radiation Oncology • Biology • Physics 2017 97, 976-985DOI: (10.1016/j.ijrobp.2016.12.024) Copyright © 2017 The Authors Terms and Conditions

Table E5 International Journal of Radiation Oncology • Biology • Physics 2017 97, 976-985DOI: (10.1016/j.ijrobp.2016.12.024) Copyright © 2017 The Authors Terms and Conditions

Table E6 International Journal of Radiation Oncology • Biology • Physics 2017 97, 976-985DOI: (10.1016/j.ijrobp.2016.12.024) Copyright © 2017 The Authors Terms and Conditions

Table E7 International Journal of Radiation Oncology • Biology • Physics 2017 97, 976-985DOI: (10.1016/j.ijrobp.2016.12.024) Copyright © 2017 The Authors Terms and Conditions

Table E8 International Journal of Radiation Oncology • Biology • Physics 2017 97, 976-985DOI: (10.1016/j.ijrobp.2016.12.024) Copyright © 2017 The Authors Terms and Conditions