Protocol. This trial protocol has been provided by the authors to give readers additional information about their work.

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1 Protocol This trial protocol has been provided by the authors to give readers additional information about their work. Protocol for: Wilt TJ, Brawer MK, Jones KM, et al. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med 2012;367: DOI: /NEJMoa

2 May 9, 2012 Re: R3 Radical Prostatectomy Versus Observation for Localized Prostate Cancer "This supplement contains the following items: 1. Original protocol, final protocol, summary of changes. 2. Original statistical analysis plan, final statistical analysis plan, summary of changes" Sincerely and thank you, Timothy J. Wilt, M.D., MPH, Professor of Medicine Minneapolis VA Center for Chronic Disease Outcomes Research 1 Veterans Drive (111 0) Minneapolis, MN Phone: Fax: Tim.wilt@va.gov

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313 PIVOT Protocol Refinements and Updates for A priori Analyses Some Which will be incorportated into the Initial PIVOT Manuscripts 11/5/10 Intended for Writing Group Purposes Meeting Discussions: January 6 th and 8 th, 2010: Writing Group Members: Wilt, Brawer, Barry, Aronson, Wei, Jones, Culkin, Wheeler Manuscript #1: The Prostate cancer Intervention Versus Observation Trial (PIVOT): a VA/NCI/AHRQ Randomized Trial Comparing Radical Prostatectomy With Watchful Waiting In Men with Clinically Localized Prostate Cancer. Main Analyses: 1) Main Outcomes: Primary: Overall Mortality: Time to death from any cause; Secondary: Prostate Cancer Specific Mortality: Time to prostate cancer death Defined as Death Adjudicated by Endpoints Committee as: Definitely or Probably Due to Prostate Cancer or Definitely or Probably Due to Prostate Cancer Treatment a) Intention to treat (RP vs. WW as randomized) analysis a. Time of analysis: i. Time to event ii. Prespecified intervals (30d, mean/median FU [approx 13 years], 5, 10) iii. Time to intervention: 1. RP: time to patients receiving RP (n/n, %, mean time, hazard curves) WW: time to patients receiving RP (n/n, %, mean time, hazard curves) Type of approach Type of procedure Reasons for breach of protocol 2. RP Group: time to patients receiving any definitive therapy (RP, EBRT or Brachytherapy) (n/n, %, mean time) WW Group: pts receiving any definitive therapy (n/n,%, mean time) b. Subgroups: 4 major prespecified: Age, Race, PSA, Tumor characteristic) i. Age: (< vs. >=65) ii. Race: White, Black, Other iii. PSA: < vs >= 10 ng/ml as determined by local laboratory: 1. Central PSA Laboratory data will be utilized to assess disease progression outcomes iv. Gleason Histology: , 7, 8 10 or <7 vs. >=7 1. The Histologic Grade and Clinical Stage used for all analyses will be that ascribed by the local site pathologists and investigators v. Tumor stage: clinical stage as attributed at randomization visit 1. In particular: T1C and Tumors detected by elevated PSA or change in PSA (Q4: Form 2) vi. Tumor risk classification using clinical stage, PSA, Grade: low, medium high vii. Above data as continuous and/or categorical variables in Cox hazards model viii. Tests of interaction and effect modification between variables and outcomes ix. Patient comorbidity scores; Charlson 0 vs. >=1 (Modified 10/10 in Perry Point); Performance Status: Form 02 Q5: (Response of 0 1) Fully active or Symptoms but ambulatory and able to do light work vs. Response of 2 4. Self reported

314 health status of: good, VG or Excellent vs: worse health status. Comorbidity classification revised 10/10 at Perry Point. b) Sensitivity analyses: I ) Treatment received 1) RP Group: patients receiving RP 2) WW group: patients not receiving RP 3) RP Group: patients receiving any definitive therapy (RP, EBRT or Brachytherapy) 4) WW Group: patients not receiving any definitive therapy 5) Excluding randomized subjects without cancer at randomization by local pathology reading 6) Excluding randomized subjects without cancer at randomization as determined by central reading of submitted biopsy specimen 7) Analyses of mortality outcomes by histological grade and tumor risk classification according to central laboratory grading ii) Excluding men where local or central biopsy specimen reading did not confirm cancer 1) Local biopsy specimen negative for cancer (regardless of central reading) 2) Central reading of submitted biopsy specimen was negative for cancer (regardless of local reading) 2) Additional Secondary Outcomes (not QOL related): a. Disease Progression or recurrence: Form 4:Q7 Stable (NEM); Stable (DZ); Disease; asym; DZ symp i. Local ii. Regional iii. Metastatic: Note original protocol: 1. Additionally: + Bone scans coded 4 or 5 for KQ4 on Form 4. (Sensitivity secondary analyses will include adding those with coding of 3) iv. CaP related hospitalizations Q8 b. PSA free survival /progression: (criteria remain to be finalized 11/10) i. PSA free survival: Survival with PSA remaining < 0.04 ii. PSA recurrence following RP: iii. Post RP PSA value of >= 0.2 with a subsequent confirmatory value >= 0.2 from the central laboratory (categorized as Yes/No and then time to recurrence...with the time to recurrence being the 2nd confirmatory report). iv. PSA persistence following RP 1. PSA does not fall to < 0.04 at 6 months after RP v. PSA progression 1. Following RP: a. Definition to be clarified b. Institution of hormonal or other therapy for PSA rise or elevation 2. In WW group: a. PSA > 20 and at least 2x baseline: b. Institution of hormonal or other therapy for PSA rise or elevation c. Bony Metastases: + Bone scans: Baseline, Year 4, 8, 12 [Form 4: Code 4 or 5: Definitely malignant: axial skeleton; definitely malignant > 1 site)). Will also include Cod 3 if other supportive evidence of bony metastases.

315 d. Additional Treatment i. Mechanical ii. Surgical iii. Hormonal therapy (orchiectomy, LHRH, AA) ( n/n, %, time to use) iv. Palliative radiation (n/n, % time to use) v. Laminectomy (n/n, % time to use) e. Reasons for treatment i. Local Disease ii. Regional Disease iii. Metastatic Disease iv. Abnormal Biomarkers f. 30 day surgical complications in RP group by complication g. Surgical Histopathologic Parameters: i. Confined to prostate ii. Capsular invasion iii. Capsular penetration iv. Surgical margins involved v. Seminal vesical invasivion vi. Metastatic Disease vii. Unknown 3) Tables and Figures (main manuscript): a. Figure 1: CONSORT Study Flow Diagram b. Table 1: Base Line Characteristics (see Baseline Paper) c. Table 2: Cause of Death d. Figure 2a: All cause mortality; 2b: <65 vs. >=65 e. Figure 3: Disease specific mortality f. Table 3: Cumulative incidence of Main Endpoints: 5 and 10 years i. Overall mortality ii. Disease Specific Mortality iii. Distant Metastases;: Baseline, Year 1, 5, 10, end of study iv. Local Progression v. Use of Hormonal Therapy vi. Additional palliative treatment: radiation, laminectomy, chemotherapy (individually and cumulatively)

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