NRGGU 005 Phase III IGRT and SBRT vs

NRG-GU 005 Phase III IGRT and SBRT vs. IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer Rod Ellis, MD Chair Penn State University NRG Semi-Annual Meeting July 17 th 2020 @NRGOnc NRG Oncology

Disclosures • Boston Scientific- Ad Board, Research NRG-GU 005

Schema S T R A T I F Y Risk Group 1. Gleason score 7(3+4) with PSA <10 ng/m. L 2. Gleason score 7(3+4) with 10 ng/m. L <= PSA < 20 ng/m. L 3. Gleason score 6(3+3) with 10 ng/m. L < PSA < 20 ng/m. L Use of Rectal Manipulation 1. No 2. Rectal balloon 3. Space. OAR 4. Space. OAR and rectal balloon R A N D O M I Z E Arm 1: IMRT 70 Gy in 28 fractions of 2. 5 Gy to the prostate or 60 Gy in 20 fractions of 3 Gy +/- proximal 1 cm of seminal vesicles Minimal Margins: 8 mm uniform in expansion, 5 mm posteriorly IMRT Standard Arm 1) 70 Gy in 28 fractions 2) 60 Gy in 20 fractions Arm 2: SBRT 36. 25 Gy in 5 fractions of 7. 25 Gy to the prostate +/- proximal 1 cm of seminal vesicles Minimal Margins: 5 mm superior inferior & laterally, 3 mm anterior & posterior *Asterisked information @NRGOnc NRG Oncology NRG-GU 005

@NRGOnc NRG Oncology NRG-GU 005

Table 3 Patient and Tumor Characteristics for All Randomized Patients in NRG-GU 005 - Data as of 04/30/2020 Patient or Tumor Characteristic IMRT (n=127) SBRT (n=134) Total (n=261) Age (years) ≤ 49 1 ( 0. 8%) 1 ( 0. 7%) 2 ( 0. 8%) 50 - 59 14 ( 11. 0%) 15 ( 11. 2%) 29 ( 11. 1%) 60 - 69 70 ( 55. 1%) 52 ( 38. 8%) 122 ( 46. 7%) ≥ 70 42 ( 33. 1%) 66 ( 49. 3%) 108 ( 41. 4%) Race American Indian or Alaska Native 0 ( 0. 0%) 1 ( 0. 7%) 1 ( 0. 4%) Asian 2 ( 1. 6%) 3 ( 2. 2%) 5 ( 1. 9%) Black or African American 20 ( 15. 7%) 13 ( 9. 7%) White 102 ( 80. 3%) 112 ( 83. 6%) 214 ( 82. 0%) More than one race 1 ( 0. 8%) 0 ( 0. 0%) 1 ( 0. 4%) Unknown 2 ( 1. 6%) 5 ( 3. 7%) 7 ( 2. 7%) 33 ( 12. 6%) Ethnicity Hispanic or Latino 4 ( 3. 1%) 3 ( 2. 2%) 7 ( 2. 7%) Not Hispanic or Latino 123 ( 96. 9%) 128 ( 95. 5%) 251 ( 96. 2%) Unknown 0 ( 0. 0%) 3 ( 2. 2%) 3 ( 1. 1%) Risk Group Gleason score 7 (3+4) with PSA < 10 ng/ml 95 ( 74. 8%) 102 ( 76. 1%) 197 ( 75. 5%) Gleason score 7 (3+4) with 10 ng/ml ≤ PSA < 20 ng/ml 27 ( 21. 3%) 21 ( 15. 7%) 48 ( 18. 4%) Gleason score 6 (3+3) with 10 ng/ml < PSA < 20 ng/ml 5 ( 3. 9%) 11 ( 8. 2%) 16 ( 6. 1%) Rectal Manipulation No 57 ( 44. 9%) 54 ( 40. 3%) 111 ( 42. 5%) Rectal Balloon 3 ( 2. 4%) 1 ( 0. 7%) 4 ( 1. 5%) Space. OAR 60 ( 47. 2%) 69 ( 51. 5%) 129 ( 49. 4%) Space. OAR and rectal balloon 7 ( 5. 5%) 10 ( 7. 5%) 17 ( 6. 5%) Combined Gleason Score 6 5 ( 3. 9%) 11 ( 8. 2%) 16 ( 6. 1%) 7 122 ( 96. 1%) 123 ( 91. 8%) 245 ( 93. 9%) T-Stage T 1 98 ( 77. 2%) 101 ( 75. 4%) 199 ( 76. 2%) T 2 29 ( 22. 8%) 33 ( 24. 6%) 62 ( 23. 8%) N-Stage N 0 127 (100. 0%) 134 (100. 0%) 261 (100. 0%) M-Stage M 0 127 (100. 0%) 134 (100. 0%) 261 (100. 0%) Zubrod Performance Status 0 105 ( 82. 7%) 120 ( 89. 6%) 225 ( 86. 2%) 1 22 ( 17. 3%) 14 ( 10. 4%) 36 ( 13. 8%) Consent to tissue collection No 35 ( 27. 6%) 31 ( 23. 1%) 66 ( 25. 3%) Yes 92 ( 72. 4%) 103 ( 76. 9%) 195 ( 74. 7%) NRG-GU 005

Audience Survey Question • How often are you using Space. OAR off protocol in your clinical practice for patients with prostate cancer? 1. 0% 2. <10% 3. <25% 4. <50% 5. >50% 6. >75% NRG-GU 005