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1 Supplementary Online Content Borocas DA, Alvarez J, Resnick MJ, et al. Association between radiation therapy, surgery, or observation for localized prostate cancer and patient-reported outcomes after 3 years. JAMA. doi: /jama efigure 1. Diagram of the Assembly of the Analytic Cohort in the Comparative Effectiveness Analyses of Surgery and Radiation (CEASAR) Study etable 1. Survey Response Rates and Missing Data by Treatment and by Time Point emethods. Explanation of Handling of Missing Data and Imputation etable 2. Sexual function outcomes: Unadjusted Expanded Prostate Cancer Index Composite domain scores and selected individual item responses by treatment and time point; Adjusted differences between groups in Expanded Prostate Cancer Index Composite domain scores and selected individual item responses by treatment and time point efigure 2. Adjusted treatment trajectories for sexual domain and hormone domain, by 5 treatment categories including subgroups of radical prostatectomy by nerve-sparing status and subgroups of external beam radiation therapy by use of androgen deprivation therapy etable 3. Erections Sufficient for Intercourse 3 Years After Treatment, by 5 Treatment Categories: radical prostatectomy with and without nerve-sparing, external beam radiation therapy with and without androgen deprivation therapy, and active surveillance etable 4. Urinary function outcomes: Unadjusted Expanded Prostate Cancer Index Composite domain scores and selected individual item responses by treatment and time point; Adjusted differences between groups in Expanded Prostate Cancer Index Composite domain scores and selected individual item responses by treatment and time point etable 5. Bowel function outcomes: Unadjusted Expanded Prostate Cancer Index Composite domain scores and selected individual item responses by treatment and time point; Adjusted differences between groups in Expanded Prostate Cancer Index Composite domain scores and selected individual item responses by treatment and time point etable 6. Hormone function outcomes: Unadjusted Expanded Prostate Cancer Index Composite domain scores by treatment and time point; Adjusted differences between groups in Expanded Prostate Cancer Index Composite domain scores by treatment and time point etable 7. Global Quality of Life Outcomes: Unadjusted domain scores from the Short Form-36 by treatment and time point; Adjusted differences between groups in domain scores from the Short Form-36 by treatment and time point etable 8. Unadjusted 3-year Expanded Prostate Cancer Index Composite Domain Scores by Subgroup, and Number in Each Subgroup etable 9. Unadjusted Disease-Specific and Overall Survival Probabilities by Treatment This supplementary material has been provided by the authors to give readers additional information about their work American Medical Association. All rights reserved.

2 SupplementalTable of Contents 1. efigure 1: Diagram of the Assembly of the Analytic Cohort in the Comparative Effectiveness Analyses of Surgery and Radiation (CEASAR) Study Page 1 2. etable 1: Survey Response Rates and Missing Data by Treatment and by Time Point 2 3. emethods: Explanation of Handling of Missing Data and Imputation 3 4. etable 2: Sexual function outcomes: Unadjusted Expanded Prostate Cancer Index Composite domain scores and selected individual item responses by treatment and time point; Adjusted differences between groups in Expanded Prostate Cancer Index Composite domain scores and selected individual item responses by treatment and time point. 5. efigure 2: Adjusted treatment trajectories for sexual domain and hormone domain, by 5 treatment categories including subgroups of radical prostatectomy by nerve-sparing status and subgroups of external beam radiation therapy by use of androgen deprivation therapy 6. etable 3: Erections Sufficient for Intercourse 3 Years After Treatment, by 5 Treatment Categories: radical prostatectomy with and without nerve-sparing, external beam radiation therapy with and without androgen deprivation therapy, and active surveillance 7. etable 4. Urinary function outcomes: Unadjusted Expanded Prostate Cancer Index Composite domain scores and selected individual item responses by treatment and time point; Adjusted differences between groups in Expanded Prostate Cancer Index Composite domain scores and selected individual item responses by treatment and time point. 8. etable 5. Bowel function outcomes: Unadjusted Expanded Prostate Cancer Index Composite domain scores and selected individual item responses by treatment and time point; Adjusted differences between groups in Expanded Prostate Cancer Index Composite domain scores and selected individual item responses by treatment and time point. 9. etable 6. Hormone function outcomes: Unadjusted Expanded Prostate Cancer Index Composite domain scores by treatment and time point; Adjusted differences between groups in Expanded Prostate Cancer Index Composite domain scores by treatment and time point. 10. etable 7: Global Quality of Life Outcomes: Unadjusted domain scores from the Short Form-36 by treatment and time point; Adjusted differences between groups in domain scores from the Short Form-36 by treatment and time point. 11. etable 8: Unadjusted 3-year Expanded Prostate Cancer Index Composite Domain Scores by Subgroup, and Number in Each Subgroup etable 9: Unadjusted Disease-Specific and Overall Survival Probabilities by Treatment 16

3 efigure 1. Diagram of the Assembly of the Analytic Cohort in the Comparative Effectiveness Analyses of Surgery and Radiation (CEASAR) Study Potentially eligible patients invited to participate (n=7,343) Returned at least one survey at any time point (n=3,709) Refused (n=3,634) Did not meet inclusion criteria (n=440) 1. No baseline survey (n=16) 2. Older than 80 (n=4) 3. Not enrolled within 6 months of diagnosis (n=263) 4. PSA missing or > 50 ng/ml (n=82) 5. Clinical tumor (T) category not T1 or T2 (n=55) 6. Clinical nodal (N) category not N0 (n=10) 7. Distant metastasis (M) category not M0 (n=10) Met all inclusion criteria (n=3,269) Treated with radical prostatectomy, external beam radiation therapy, or active surveillance (n=2,750) Treatment was not radical prostatectomy, external beam radiation therapy, or active surveillance (n=519) Did not complete a follow-up survey (n=200) Completed at least one post-baseline survey* (n=2,550) Survey Radical Prostatectomy External Beam Radiation Therapy Active All Baseline 1523 (94%) 598 (93%) 429 (88%) 2,550 (93%) 6-month 1448 (89%) 580 (90%) 411 (84%) 2,440 (89%) 12-month 1425 (88%) 560 (87%) 387 (79%) 2,372 (86%) 36-month 1307 (81%) 482 (75%) 349 (71%) 2,138 (78%) Any after baseline 1523 (94%) 598 (93%) 429 (88%) 2,550 (93%) *etable 1 contains additional detail on missing data within returned surveys. 1

4 etable 1: Survey Response Rates and Missing Data by Treatment and by Time Point Time point All Radical Prostatectomy External Beam Radiation Therapy Active Baseline Returned a survey Yes 2550 (100%) 1523 (100%) 598 (100%) 429 (100%) No (missing) 0 (0%) 0 (0%) 0 (0%) 0 (0%) Completed Expanded Prostate Cancer Index Composite domain (Percentage of survey respondents) Sexual 2407 (94%) 1447 () 558 (93%) 402 (94%) Urinary Incontinence 2451 (96%) 1467 (96%) 575 (96%) 409 () Urinary Irritative 2446 (96%) 1463 (96%) 574 (96%) 409 () Bowel 2492 (98%) 1492 (98%) 585 (98%) 415 (97%) Hormone 2442 (96%) 1467 (96%) 563 (94%) 412 (96%) 6 month Returned a survey Yes 2439 (96%) 1448 () 580 (97%) 411 (96%) No (missing) 111 (4%) 75 (5%) 18 (3%) 18 (4%) Completed Expanded Prostate Cancer Index Composite domain (Percentage of survey respondents) Sexual 2338 (96%) 1407 (97%) 541 (93%) 390 () Urinary Incontinence 2418 (99%) 1434 (99%) 576 (99%) 408 (99%) Urinary Irritative 2393 (98%) 1419 (98%) 571 (98%) 403 (98%) Bowel 2426 (99%) 1439 (99%) 576 (99%) 411 (100%) Hormone 2384 (98%) 1417 (98%) 562 (97%) 405 (99%) 12 month Returned a survey Yes 2372 (93%) 1425 (94%) 560 (94%) 387 (90%) No (missing) 178 (7%) 98 (6%) 38 (6%) 42 (10%) Completed Expanded Prostate Cancer Index Composite domain (Percentage of survey respondents) Sexual 2296 (97%) 1401 (98%) 535 (96%) 360 (93%) Urinary Incontinence 2274 (96%) 1368 (96%) 532 () 374 (97%) Urinary Irritative 2323 (98%) 1397 (98%) 547 (98%) 379 (98%) Bowel 2357 (99%) 1415 (99%) 557 (99%) 385 (99%) Hormone 2325 (98%) 1401 (98%) 542 (97%) 382 (99%) 36 month Returned a survey Yes 2138 (84%) 1307 (86%) 482 (81%) 349 (81%) No (missing) 412 (16%) 216 (14%) 116 (19%) 80 (19%) Completed Expanded Prostate Cancer Index Composite domain (Percentage of survey respondents) Sexual 2059 (96%) 1276 (98%) 454 (94%) 329 (94%) Urinary Incontinence 2083 (97%) 1277 (98%) 467 (97%) 339 (97%) Urinary Irritative 2088 (98%) 1282 (98%) 466 (97%) 340 (97%) Bowel 2122 (99%) 1297 (99%) 476 (99%) 349 (100%) Hormone 2091 (98%) 1282 (98%) 464 (96%) 345 (99%) 2

5 emethods Handling of Missing Data and Imputation From the CEASAR analysis cohort, among those with the relevant treatments for this analysis, patients with no postbaseline outcome measures (EPIC domains scores) were excluded. The resulting data set is referred to as the analytic cohort (n=2,550). According to the EPIC scoring algorithm, patients who answered at least 80% of questions within a particular domain received a score for that domain (computed as an average of the scores on questions that were answered, scaled from 0 to 100). Those who answered less than 80% of questions on a particular domain were considered to have missing data for that domain. 1 Multiple Imputation Missing values of regression model covariates, including the values of the baseline EPIC domain score or individual EPIC item, were imputed using the MICE (Multiple imputation using chained equations) multiple imputation procedure. 2, 3 No outcome variables were imputed. In this procedure, missing values of covariates are imputed by modeling each covariate as an outcome in a regression model, using all other model covariates as predictors. In this case, only baseline data 4, 5, 6 (excluding treatment) were used. This is described by Harrell and implemented using the rms package in R. Multiple imputation was used to avoid case-wise deletion of all observations with at least one missing value of the independent variables. The imputation and regression model fitting with imputed data involve the following three steps: imputing the data using the imputation models, estimating coefficient parameters and their standard errors in the analysis regression models, and adjusting the standard error estimates to account for the variability associated with the imputation procedure. To impute missing data on a covariate (X), we first imputed the missing data using a random sample of non-missing X. Then a flexible additive model was fit on a bootstrap resampled dataset using X as the outcome. Using this model, we obtained fitted values for the variable. To impute a missing value, we found non-missing X whose fitted value was closest to the fitted value of the missing observation, and imputed the missing value with the matching non-missing X. This approach is referred to as predictive mean matching. 4 This resample-model-impute step was repeated 15 times after a burn-in period of 10 iterations with the missing values updated with the imputed values after each step. Then the final model was fit using the complete data set using the values imputed at the last iteration, and the standard error estimates were adjusted to account for additional uncertainty associated with the imputation as described in Harrell. 4 References: 1. Sanda MG, Wei JT, Litwin MS. Scoring Instructions for the Expanded Prostate Index Composite Short Form (EPIC- 26). University of Michigan Web Site. PIC%2026.pdf. Accessed August 15, Schafer JL. Analysis of Incomplete Multivariate Data. London (UK): Chapman & Hall; White IR, Royston P, Wood AM. Multiple imputation using chained equations: Issues and guidance for practice. Stat Med. 2011;30: Harrell FE, Jr. Regression Modeling Strategies: With Applications to Linear Models, Logistic Regression, and Survival Analysis. New York (NY): Springer-Verlag; Harrell FE, Jr. rms: Regression Modeling Strategies (R package version 4.5-0). R Foundation for Statistical 6. Computing Web Site. Accessed August 15, R: A language and environment for statistical computing. R Foundation for Statistical Computing Web Site. Accessed August 15,

6 etable 2. Sexual function outcomes: Unadjusted Expanded Prostate Cancer Index Composite domain scores and selected individual item responses by treatment and time point; Adjusted differences between groups in Expanded Prostate Cancer Index Composite domain scores and selected individual item responses by treatment and time point. Time Domain a Radical Prostatectomy External Beam Radiation Therapy Active (N=1523) (N=598) (N=429) Effect Radical Prostatectomy vs. Active p- Interval value External Beam Radiation Therapy vs. Active p- Effect Interval value Sexual function Unadjusted mean ( CI) domain score Adjusted linear model d ; effect size = point difference between groups Baseline 65.2 (63.5, 66.9) 52.3 (49.6, 55.0) 63.1 (60.0, 66.2) Effect Radical Prostatectomy vs. External Beam Radiation Therapy Interval 6 month 31.0 (29.4, 32.5) 36.9 (34.0, 39.8) 61.1 (57.9, 64.3) b [-48.4, -28.9] < b [-27.3, -7.5] < b [-24.2, -18.3] < year 37.1 (35.4, 38.7) 38.4 (35.6, 41.2) 61.7 (58.2, 65.1) b [-29.9, -23.9] < b [-14.0, -6.9] < b [-19.5, -13.4] < year (primary outcome) 40.7 (38.9, 42.6) 38.9 (35.8, 42.0) 53.8 (50.0, 57.7) b [-20.6, -11.7] < [ -9.2, 0.7] b [-15.1, -8.7] <0.001 Individual Items c Sexual function bother Unadjusted num (%) Adjusted logistic model d ; effect size = odds ratio of moderate or big problem Baseline 387 (27%) 182 (32%) 96 (24%) 6 month 787 (56%) 208 (37%) 87 (22%) 5.1 [3.9, 6.6] < [1.3, 2.3] < [2.3, 3.8] < year 711 (50%) 207 (39%) 79 (22%) 4.6 [3.5, 6.0] < [1.5, 2.7] < [1.8, 2.9] < year 566 (44%) 160 (35%) 94 (28%) 2.2 [1.7, 2.9] < [0.8, 1.6] [1.5, 2.6] <0.001 Erection insufficient for penetration Unadjusted num (%) Adjusted logistic model d ; effect size = odds ratio of insufficient erection Baseline 573 (39%) 319 (56%) 166 (41%) 6 month 1128 (80%) 397 (71%) 169 (43%) 12.6 [9.4, 16.9] < [1.9, 3.5] < [3.6, 6.5] < year 1027 (74%) 387 (72%) 152 (41%) 7.6 [5.8, 10.1] < [1.7, 3.2] < [2.5, 4.4] < year 893 (70%) 326 (71%) 168 (51%) 3.4 [2.5, 4.6] < [1.1, 2.3] [1.5, 2.9] <0.001 Footnote: a. Domain scores are from the Expanded Prostate Cancer Index Composite (EPIC-26). Domain scores are scaled from 0 to 100, with higher score indicating better function. The left side of the table shows unadjusted mean domain score and confidence interval ( CI). The right side shows multivariable model results. The effect size in the multivariable model for domain score indicates the adjusted mean point difference between groups at each time point. A minimally important difference in score is points. The primary outcome was the difference in domain score at 3 years. b. Signifies that the difference between groups exceeds the minimally important difference for clinical significance. c. Individual items are clinically important components of the domain, scored on a Likert scale and then dichotomized for group comparisons. The left side of the table shows the unadjusted number (%) of patients reporting a moderate or big problem. The right side shows the adjusted odds ratio of reporting a moderate or big problem comparing treatment groups. p- value 4

7 d. All regression models are adjusted for baseline domain score, age, race, comorbidity, disease risk group, physical function, social support, depression, medical decision-making style and accrual site. 5

8 efigure 2: Adjusted mean Expanded Prostate Cancer Index Composite (EPIC-26) domain score ( CI), longitudinally by five treatment groups: acgve surveillance, external beam radiagon therapy only, external beam radiagon therapy with androgen deprivagon therapy, non-nerve sparing radical prostatectomy, and nerve-sparing prostatectomy. 100 Sexual Domain Score Hormone Domain Score Domain Score Time since treatment start (months) Active External Beam Radiation Therapy Only External Beam Radiation Therapy + Androgen Deprivation Therapy Non nerve sparing Radical Prostatectomy Nerve sparing Radical Prostatectomy Time since treatment start (months) 20 0 Figure Legend: Expanded Prostate Cancer Index Composite (EPIC-26) domain scores are scaled from 0 to 100, with higher score indicagng beoer funcgon. Shading indicates CI. Time zero is the date of treatment for radical prostatectomy and external beam radiagon therapy pagents, and date of diagnosis for acgve surveillance pagents. The regression model esgmates adjusted effect of treatment on domain score, controlling for baseline domain score, age, race, comorbidity, disease risk group, physical funcgon, social support, depression, medical decision-making style and accrual site. The primary outcome is 3-year difference in domain score. Minimum clinically meaningful differences are for sexual funcgon and 4 for hormonal domain. Five treatment groups (acgve surveillance, external beam radiagon therapy only, external beam radiagon therapy with androgen deprivagon therapy, non-nerve sparing radical prostatectomy, and nerve-sparing prostatectomy) are depicted. 6

9 etable 3: Erections Sufficient for Intercourse 3 Years After Treatment, by 5 Treatment Categories: active surveillance, radical prostatectomy with and without nervesparing, and external beam radiation therapy with and without androgen deprivation therapy Erections insufficient for intercourse at baseline Erections sufficient for intercourse at baseline Erection sufficient for intercourse at 3 years Erection sufficient for intercourse at 3 years Unadjusted % Predicted Probability ( CI) Unadjusted % Predicted Probability ( CI) Active 11% (13/119) 19% [13%, 27%] 74% (143/192) 73% [65%, 80%] Nerve-sparing radical prostatectomy 11% (27/253) 6% [ 4%, 9%] 46% (219/480) 44% [36%, 52%] Non-nerve-sparing radical prostatectomy 8% (6/72) 4% [ 2%, 8%] 34% (36/107) 34% [23%, 47%] External beam radiation therapy without androgen deprivation therapy 12% (16/130) 14% [ 9%, 21%] 56% (63/113) 65% [54%, 75%] External beam radiation therapy with androgen deprivation therapy 8% (8/105) 12% [ 7%, 20%] 46% (39/84) 61% [47%, 73%] Footnote: The multivariable regression model from which predicted probability is generated is adjusted for age, race, comorbidity, prostate cancer risk group, physical function, social support, depression, medical decision-making style and accrual site 7

10 etable 4. Urinary function outcomes: Unadjusted Expanded Prostate Cancer Index Composite domain scores and selected individual item responses by treatment and time point; Adjusted differences between groups in Expanded Prostate Cancer Index Composite domain scores and selected individual item responses by treatment and time point. Time Domains a External Beam Radiation Therapy Radical Prostatectomy Active Radical Prostatectomy vs. Active External Beam Radiation Therapy vs. Active (N=1523) (N=598) (N=429) Effect Interval p-value Effect Interval p-value Effect Incontinence Unadjusted mean ( CI) domain score Adjusted linear model d ; effect size = point difference between groups Baseline 86.7 (85.5, 87.8) 88.2 (86.7, 89.6) 88.7 (87.0, 90.4) Radical Prostatectomy vs. External Beam Radiation Therapy Interval p-value 6 month 65.4 (63.9, 66.9) 86.2 (84.6, 87.7) 89.2 (87.5, 90.9) b [-35.9, -19.4] < [ -9.0, 7.5] b [-29.3, -24.4] < year 70.7 (69.2, 72.1) 86.4 (84.8, 88.1) 88.9 (87.3, 90.5) b [-20.9, -16.1] < [ -0.9, 4.0] b [-22.6, -17.6] < year (primary outcome) 71.8 (70.4, 73.2) 85.3 (83.4, 87.1) 85.4 (83.2, 87.5) b [-16.0, -9.3] < [ 1.8, 8.9] b [-20.5, -15.4] <0.001 Urinary Irritative Unadjusted mean ( CI)) domain score Adjusted linear model d ; effect size = point difference between groups Baseline 83.2 (82.3, 84.1) 82.3 (80.9, 83.7) 83.9 (82.3, 85.5) 6 month 88.2 (87.5, 88.9) 83.8 (82.5, 85.1) 86.4 (85.0, 87.7) 2.2 [ -3.3, 7.7] [ -6.3, 4.9] [ 1.3, 4.5] < year 89.6 (88.9, 90.3) 84.8 (83.5, 86.0) 85.7 (84.2, 87.2) 4.5 [ 3.0, 6.0] < [ 0.9, 4.4] [ 0.4, 3.3] year (primary outcome) 90.3 (89.6, 91.0) 85.9 (84.6, 87.3) 86.0 (84.5, 87.6) 5.2 b [ 3.2, 7.2] < [ 0.4, 4.9] [ 1.1, 4.1] <0.001 Individual Items c Urinary function bother Unadjusted num (%) Adjusted logistic model d ; effect size = odds ratio of moderate or big problem Baseline 216 (15%) 70 (12%) 51 (13%) 6 month 244 (17%) 73 (13%) 39 (10%) 2.6 [1.8, 3.7] < [0.8, 1.7] [1.6, 3.1] < year 173 (12%) 54 (10%) 36 (10%) 1.5 [1.0, 2.3] [0.5, 1.3] [1.3, 2.9] < year 154 (12%) 49 (10%) 30 ( 9%) 1.4 [0.9, 2.2] [0.5, 1.4] [1.1, 2.5] Urinary leakage Unadjusted num (%) Adjusted logistic model d ; effect size = odds ratio of moderate or big problem Baseline 110 ( 7%) 24 ( 4%) 20 ( 5%) 6 month 268 (19%) 31 ( 5%) 13 ( 3%) 10.3 [5.8, 18.1] < [0.8, 3.0] [4.4, 10.0] < year 211 (15%) 32 ( 6%) 16 ( 4%) 6.0 [3.6, 9.9] < [0.6, 2.3] [3.1, 7.8] < year 175 (14%) 24 ( 5%) 20 ( 6%) 2.9 [1.8, 4.7] < [0.4, 1.2] [2.7, 7.3] <0.001 Burning on urination Unadjusted num (%) Adjusted logistic model d ; effect size = odds ratio of moderate or big problem Baseline 53 ( 4%) 24 ( 4%) 16 ( 4%) 8

11 6 month 22 ( 2%) 28 ( 5%) 6 ( 1%) 1.3 [0.5, 3.2] [1.4, 8.1] [0.2, 0.7] year 16 ( 1%) 19 ( 3%) 6 ( 2%) 1.0 [0.4, 2.4] [0.4, 3.4] [0.4, 1.7] year 22 ( 2%) 10 ( 2%) 6 ( 2%) 1.1 [0.4, 3.1] [0.3, 3.1] [0.5, 2.7] Frequent urination Unadjusted num (%) Adjusted logistic model d ; effect size = odds ratio of moderate or big problem Baseline 318 (21%) 126 (22%) 82 (20%) 6 month 261 (18%) 106 (18%) 69 (17%) 1.3 [0.9, 1.7] [0.7, 1.4] [0.9, 1.7] year 218 (15%) 82 (15%) 66 (17%) 0.8 [0.6, 1.1] [0.4, 0.8] < [1.1, 2.1] year 163 (13%) 71 (15%) 61 (18%) 0.6 [0.4, 0.8] [0.4, 0.8] [0.7, 1.5] Footnote: a. Domain scores are from the Expanded Prostate Cancer Index Composite (EPIC-26). Domain scores are scaled from 0 to 100, with higher score indicating better function. The left side of the table shows unadjusted mean domain score and confidence interval ( CI). The right side shows multivariable model results. The effect size in the multivariable model for domain score indicates the adjusted mean point difference between groups at each time point. A minimally important difference in score is 6 points for the incontinence domain and 5 points for the urinary irritative domain. The primary outcome was the difference in domain score at 3 years. b. Signifies that the difference between groups exceeds the minimally important difference for clinical significance. c. Individual items are clinically important components of the domain, scored on a Likert scale and then dichotomized for group comparisons. The left side of the table shows the unadjusted number (%) of patients reporting a moderate or big problem. The right side shows the adjusted odds ratio of reporting a moderate or big problem comparing treatment groups. d. All regression models are adjusted for baseline domain score, age, race, comorbidity, prostate cancer risk group, physical function, social support, depression, medical decisionmaking style and accrual site. 9

12 etable 5. Bowel function outcomes: Unadjusted Expanded Prostate Cancer Index Composite domain scores and selected individual item responses by treatment and time point; Adjusted differences between groups in Expanded Prostate Cancer Index Composite domain scores and selected individual item responses by treatment and time point. Time Domain a Radical Prostatectomy External Beam Radiation Therapy Active Radical Prostatectomy vs. Active External Beam Radiation Therapy vs. Active Radical Prostatectomy vs. External Beam Radiation Therapy (N=1523) (N=598) (N=429) Effect Interval p-value Effect Interval p-value Effect Interval p-value Bowel function Unadjusted mean ( CI) domain score Adjusted linear model d ; effect size = point difference between groups Baseline 94.0 (93.3, 94.6) 93.4 (92.5, 94.3) 94.0 (92.8, 95.2) 6 month 94.9 (94.3, 95.4) 89.5 (88.2, 90.8) 94.4 (93.3, 95.6) -1.1 [ -5.5, 3.3] b [-10.3, -1.2] b [ 3.2, 6.1] < year 94.8 (94.2, 95.4) 88.6 (87.4, 89.9) 94.0 (92.7, 95.3) 0.7 [ -0.4, 1.9] [ -5.1, -1.9] < b [ 2.8, 5.6] < year (primary outcome) 95.0 (94.4, 95.6) 90.3 (89.1, 91.6) 93.5 (92.1, 94.9) 1.4 [ -0.2, 3.0] [ -3.5, 0.3] [ 1.6, 4.3] <0.001 Individual Items c Bowel function bother Unadjusted num (%) Adjusted logistic model d ; effect size = odds ratio of moderate or big problem Baseline 53 ( 4%) 22 ( 4%) 19 ( 5%) 6 month 59 ( 4%) 44 ( 8%) 13 ( 3%) 2.0 [1.1, 3.7] [1.6, 5.2] < [0.4, 1.1] year 45 ( 3%) 42 ( 8%) 14 ( 4%) 1.2 [0.6, 2.1] [1.0, 3.5] [0.4, 1.1] year 37 ( 3%) 29 ( 6%) 17 ( 5%) 0.6 [0.3, 1.2] [0.5, 2.1] [0.3, 1.1] Bloody stools Unadjusted num (%) Adjusted logistic model d ; effect size = odds ratio of moderate or big problem Baseline 6 ( 0%) 4 ( 1%) 4 ( 1%) 6 month 10 ( 1%) 8 ( 1%) 3 ( 1%) 1.3 [0.4, 4.7] [0.4, 5.1] [0.4, 2.3] year 11 ( 1%) 11 ( 2%) 6 ( 2%) 0.5 [0.2, 1.5] [0.3, 2.6] [0.2, 1.8] year 8 ( 1%) 8 ( 2%) 5 ( 1%) 0.4 [0.1, 1.2] [0.2, 2.8] [0.1, 1.5] Bowel urgency Unadjusted num (%) Adjusted logistic model d ; effect size = odds ratio of moderate or big problem Baseline 72 ( 5%) 21 ( 4%) 16 ( 4%) 6 month 47 ( 3%) 43 ( 7%) 17 ( 4%) 1.1 [0.6, 2.1] [1.4, 4.6] [0.3, 0.7] year 50 ( 4%) 40 ( 7%) 13 ( 3%) 0.9 [0.5, 1.6] [0.8, 2.8] [0.4, 1.0] year 34 ( 3%) 34 ( 7%) 18 ( 5%) 0.5 [0.3, 0.9] [0.8, 2.9] [0.2, 0.6] <0.001 Footnote: a. Domain scores are from the Expanded Prostate Cancer Index Composite (EPIC-26). Domain scores are scaled from 0 to 100, with higher score indicating better function. The left side of the table shows unadjusted mean domain score and confidence interval ( CI). The right side shows multivariable model results. The effect size in the multivariable model 10

13 for domain score indicates the adjusted mean point difference between groups at each time point. A minimally important difference in score is 4 points. The primary outcome was the difference in domain score at 3 years. b. Signifies that the difference between groups exceeds the minimally important difference for clinical significance. c. Individual items are clinically important components of the domain, scored on a Likert scale and then dichotomized for group comparisons. The left side of the table shows the unadjusted number (%) of patients reporting a moderate or big problem. The right side shows the adjusted odds ratio of reporting a moderate or big problem comparing treatment groups. d. All regression models are adjusted for baseline domain score, age, race, comorbidity, prostate cancer risk group, physical function, social support, depression, medical decisionmaking style and accrual site. 11

14 etable 6. Hormone function outcomes: Unadjusted Expanded Prostate Cancer Index Composite domain scores by treatment and time point; Adjusted differences between groups in Expanded Prostate Cancer Index Composite domain scores by treatment and time point. Time Domain a Radical Prostatectomy External Beam Radiation Therapy Active (N=1523) (N=598) (N=429) Effect Radical Prostatectomy vs. Active Interval p-value Effect External Beam Radiation Therapy vs. Active Interval p-value Effect Hormone function Unadjusted mean (SE) domain score Adjusted linear model c ; effect size = point difference between groups Baseline 89.8 (0.4) 86.7 (0.7) 89.7 (0.7) Radical Prostatectomy vs. External Beam Radiation Therapy Interval 6 month 89.5 (0.4) 82.9 (0.7) 90.7 (0.6) -1.5 [ -6.1, 3.0] b [-11.1, -1.9] b [ 3.3, 6.6] < year 88.5 (0.4) 82.7 (0.8) 89.5 (0.7) -0.9 [ -2.2, 0.4] [ -4.9, -1.5] < [ 0.7, 3.9] year (primary outcome) 89.5 (0.4) 87.1 (0.7) 90.1 (0.8) 1.2 [ -0.9, 3.2] [ -0.9, 3.6] [ -1.7, 1.3] 0.77 Footnote: a. Domain scores are from the Expanded Prostate Cancer Index Composite (EPIC-26). Domain scores are scaled from 0 to 100, with higher score indicating better function. The left side of the table shows unadjusted mean domain score and standard error (SE). The right side shows multivariable model results. The effect size in the multivariable model for domain score indicates the adjusted mean point difference between groups at each time point. A minimally important difference in score is 4 points. The primary outcome was the difference in domain score at 3 years. b. Signifies that the difference between groups exceeds the minimally important difference for clinical significance. c. Regression model is adjusted for baseline domain score, age, race, comorbidity, disease risk group, physical function, social support, depression, medical decision-making style and accrual site. p-value 12

15 etable 7. Global Quality of Life Outcomes: Unadjusted domain scores from the Short Form-36 by treatment and time point; Adjusted differences between groups in domain scores from the Short Form-36 by treatment and time point. Time Radical Prostatectomy External Beam Radiation Therapy Active Radical Prostatectomy vs. Active External Beam Radiation Therapy vs. Active Radical Prostatectomy vs. External Beam Radiation Therapy (N=1523) (N=598) (N=429) Effect Interval p-value Effect Interval p-value Effect Interval p-value Physical Functioning Unadjusted mean ( CI) domain score a Adjusted linear model b ; effect size = point difference between groups Baseline 87.9 [86.9, 88.9] 78.3 [76.2, 80.3] 84.0 [81.6, 86.4] 6 month 86.9 [85.8, 87.9] 74.9 [72.7, 77.1] 84.2 [82.0, 86.3] -0.6 [-2.5, 1.3] [-6.6, -2.0] < [1.6, 5.7] < year 90.0 [89.1, 91.0] 78.7 [76.6, 80.8] 86.5 [84.3, 88.6] 0.5 [-1.2, 2.1] [-3.1, 0.9] [-0.2, 3.4] year (primary outcome) 86.7 [85.6, 87.8] 74.5 [72.1, 76.9] 84.0 [81.6, 86.3] 0.3 [-2.1, 2.6] [-6.2, -0.5] [1.4, 5.8] Emotional Well Being Baseline 78.0 [77.1, 78.9] 79.2 [77.7, 80.7] 80.5 [78.9, 82.1] 6 month 81.5 [80.7, 82.4] 80.1 [78.6, 81.5] 82.3 [80.8, 83.9] -0.4 [-2.0, 1.2] [-0.6, 2.4] [-2.4, 1.5] year 81.7 [80.9, 82.6] 79.8 [78.3, 81.3] 81.4 [79.7, 83.1] 0.5 [-1.0, 2.1] [-1.5, 2.1] [-1.3, 1.7] year (primary outcome) 81.7 [80.8, 82.5] 80.3 [78.7, 81.9] 82.1 [80.5, 83.7] 0.0 [-2.0, 2.0] [-3.1, 1.4] [-0.8, 2.5] Energy/Fatigue Baseline 72.4 [71.4, 73.4] 68.3 [66.7, 70.0] 71.5 [69.7, 73.4] 6 month 71.5 [70.5, 72.6] 64.7 [62.9, 66.5] 70.5 [68.6, 72.5] -0.5 [-2.4, 1.5] [-6.5, -1.9] < [1.8, 5.8] < year 72.0 [70.9, 73.0] 64.5 [62.7, 66.3] 71.0 [69.0, 73.0] -0.3 [-2.1, 1.4] [-5.4, -1.3] [1.2, 4.8] year (primary outcome) 70.9 [69.9, 71.9] 65.2 [63.2, 67.3] 70.2 [68.1, 72.2] 1.3 [-1.0, 3.7] [-3.5, 1.9] [0.2, 4.1] Footnote: a. Domain scores are from the Medical Outcomes Study Short Form-36 general quality of life instrument. Domain scores are scaled from 0 to 100, with higher score indicating better function or less disability. The left side of the table shows unadjusted mean domain score and confidence interval ( CI). The right side shows multivariable model results. The effect size in the multivariable model for domain score indicates the adjusted mean point difference between groups at each time point. A minimally important difference in score is estimated as 7 for Physical Functioning, 6 for Emotional Well-Being, and 9 for Energy/Fatigue. The primary outcome was the difference in domain score at 3 years. b. All regression models are adjusted for baseline domain score, age, race, comorbidity, prostate cancer risk group, physical function, sexual domain score and urinary incontinence domain score on the Expanded Prostate Cancer Index Composite, social support, depression, medical decision-making style and accrual site. 13

16 etable 8: Unadjusted 3-year Expanded Prostate Cancer Index Composite and Short Form 36 Domain Scores by Subgroup, and Number in Each Subgroup Radical Prostatectomy External Beam Radiation Therapy Active (N=1523) (N=598) (N=429) Expanded Prostate Cancer Index Composite Sexual Domain Baseline Domain Score Unadjusted mean ( CI) domain score, number in each group Excellent (90 to 100) 62 (59, 65) (67, 79) (80, 89) 81 Poor (0 to 30) 18 (15, 21) (9, 16) (7, 15) 55 Age at Diagnosis (years) 55 to <65 41 (39, 44) (44, 55) (52, 66) to (26, 32) (31, 39) (45, 57) 139 D'Amico Disease Risk Stratum Low risk 46 (43, 49) (41, 52) (51, 59) 255 Intermediate risk 39 (36, 41) (35, 45) (43, 61) 59 High risk 31 (27, 36) (21, 33) (20, 62) 13 Expanded Prostate Cancer Index Composite Urinary Incontinence Domain Baseline Domain Score Unadjusted mean ( CI) domain score, number in each group Excellent (100) 75 (74, 77) (90, 94) (89, 93) 192 Poor (0 to 80) 64 (61, 67) (66, 75) (68, 79) 75 Age at Diagnosis (years) 55 to <65 72 (71, 74) (84, 90) (79, 86) to (65, 71) (82, 87) (83, 90) 144 D'Amico Disease Risk Stratum Low risk 75 (73, 77) (83, 89) (84, 89) 262 Intermediate risk 71 (69, 73) (84, 89) (78, 89) 62 High risk 66 (62, 70) (79, 87) (65, 91) 13 Expanded Prostate Cancer Index Composite Urinary Irritative Domain Baseline Domain Score Unadjusted mean ( CI) domain score, number in each group Excellent (100) 94 (93, 95) (92, 96) (94, 97) 78 Poor (0 to 80) 86 (85, 88) (74, 80) (74, 80) 93 Age at Diagnosis (years) 55 to <65 91 (90, 92) (83, 88) (83, 89) to (87, 90) (84, 88) (84, 88) 145 D'Amico Disease Risk Stratum Low risk 92 (91, 93) (83, 88) (85, 88) 262 Intermediate risk 90 (89, 91) (85, 89) (80, 88) 62 High risk 87 (85, 89) (83, 88) (78, 90) 14 Expanded Prostate Cancer Index Composite Bowel Domain Baseline Domain Score Unadjusted mean ( CI) domain score, number in each group Excellent (100) 97 (96, 98) (92, 95) (95, 98) 213 Poor (0 to 80) 86 (83, 89) (77, 87) (72, 88) 34 Age at Diagnosis (years) 55 to <65 95 (94, 96) (89, 93) (90, 96) to (93, 95) (88, 92) (92, 96) 150 D'Amico Disease Risk Stratum Low risk 96 (95, 97) (88, 93) (93, 96) 269 Intermediate risk 95 (94, 96) (89, 93) (88, 95) 64 High risk 92 (90, 94) (88, 92) (74, 97) 14 Expanded Prostate Cancer Index Composite Hormonal Domain Baseline Domain Score Unadjusted mean ( CI) domain score, number in each group Excellent (100) 95 (94, 96) (92, 96) (95, 97) 133 Poor (0 to 80) 73 (71, 76) (67, 76) (66, 80) 42 Age at Diagnosis (years) 55 to <65 89 (88, 90) (84, 90) (86, 92) to (89, 92) (86, 89) (89, 94) 148 D'Amico Disease Risk Stratum Low risk 91 (90, 92) (87, 92) (90, 93) 265 Intermediate risk 90 (88, 91) (85, 90) (84, 91) 64 High risk 86 (84, 89) (81, 87) (58, 89) 14 Short Form 36 Physical Functioning Domain Baseline Domain Score Unadjusted mean ( CI) domain score, number in each group 14

17 Excellent (100) 94 (93, 95) (86, 92) (94, 97) 145 Poor (0 to 80) 64 (60, 68) (47, 56) (48, 61) 64 Baseline Expanded Prostate Cancer Index Composite Sexual Domain Excellent (90 to 100) 91 (90, 93) (77, 88) (90, 96) 85 Poor (0 to 30) 77 (73, 80) (61, 71) (60, 75) 55 Baseline Expanded Prostate Cancer Index Composite Urinary Incontinence Domain Excellent (100) 90 (89, 91) (76, 81) (83, 89) 196 Poor (0 to 80) 79 (77, 82) (60, 71) (69, 80) 77 Mental Baseline Domain Score Unadjusted mean ( CI) domain score, number in each group Excellent (90 to 100) 90 (89, 91) (87, 91) (89, 92) 118 Poor (0-70) 69 (67, 71) (59, 66) (63, 72) 61 Baseline Expanded Prostate Cancer Index Composite Sexual Domain Excellent (90 to 100) 84 (83, 85) (80, 89) (84, 89) 83 Poor (0 to 30) 78 (76, 80) (75, 82) (74, 83) 56 Baseline Expanded Prostate Cancer Index Composite Urinary Incontinence Domain Excellent (100) 83 (82, 84) (80, 84) (82, 86) 196 Poor (0 to 80) 78 (76, 80) (74, 81) (73, 81) 77 Energy Baseline Domain Score Unadjusted mean ( CI) domain score, number in each group Excellent (90 to 100) 83 (82, 85) (80, 86) (82, 88) 72 Poor (0-60) 55 (53, 58) (40, 48) (44, 54) 63 Baseline Expanded Prostate Cancer Index Composite Sexual Domain Excellent (90 to 100) 75 (73, 77) (66, 76) (73, 80) 83 Poor (0 to 30) 65 (62, 68( (54, 63) (55, 66) 56 Baseline Expanded Prostate Cancer Index Composite Urinary Incontinence Domain Excellent (100) 73 (71, 74) (65, 70) (69, 75) 196 Poor (0 to 80) 66 (64, 68) (55, 64) (60, 67) 77 Footnotes: Unadjusted mean ( CI) of 3-year domain scores for each subgroup presented in multivariable regression model Forest plots. Number of nonmissing observations for each cell is also shown. For continuous variables, results for specific values of the continuous variable are presented in the Forest plots (e.g., Age 70 years vs. 60 years), whereas mean scores in this table pertain to a range of values for each continuous variable (e.g., Age 65 to 75 years vs. 55 to <65 years), in order to facilitate the presentation of the data. Cutoff values were used to defined Excellent and Poor baseline domain scores, approximating the top and bottom quartiles of domain scores. D Amico risk classification system predicts the risk of recurrence after treatment for clinically localized prostate cancer. Low-risk disease is defined as a clinical stage T2a or less, Gleason Score 6 (3+3) or less, and a prostate-specific antigen less than 10 ng/ml. High-risk disease is defined as T2c or higher, Gleason Score 8 (3+5, 4+4, 5+3) or greater, or a prostate-specific antigen greater than 20 ng/ml. Disease not defined as low or high-risk is defined as intermediate-risk. 15

18 etable 9: Unadjusted Disease-Specific and Overall Survival Probability External Beam Radical Prostatectomy Radiation Therapy Active p (N=1523) (N=598) (N=429) Follow up time among censored, months (Q1, Q3) 40 (38, 44) 41 (38, 45) 40 (38, 44) Raw number of prostate cancer deaths among men at-risk at 3 years Estimated 3-year disease-specific survival (DSS) probability 99.9% ( ) 99.7% ( ) 100% ( ) Raw number of non-prostate cancer deaths among men at-risk at 3 years Estimated 3-year overall survival (OS) probability 98.7% ( ) 96.1% ( ) 97.1% ( ) <0.001 The estimated survival probability is computed from the number of deaths, number of patients, and each patient's follow-up time by the Kaplan-Meier method. It is not adjusted for baseline characteristics, such as age and comorbidity, which are known to differ across treatment groups. Raw number of deaths is not comparable among groups because of differences in follow-up time. 16

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