Table 3 Pivotal ST-ADT randomised control trials for IR prostate cancer men
Trial Name | Number of patients, n | Intervention | Endpoints | Comments |
|---|---|---|---|---|
RTOG-9408 [3] | 1086 IR men | 66.6 Gy / 37 fractions ± 4 months of LHRH agonist with Flutamide | 18 years bcF 57% woST-ADT 43% wST-ADT DSM 16% woST-ADT 9% wST-ADT | 15 years PCSM: FIR vs. UIR 14% vs. 28% woST-ADT 9% vs. 12% wST-ADT DM: FIR vs. UIR 5% vs. 24% woST-ADT 8% vs. 10% wST-ADT |
EORTC 22,991 [10] | 481 IR men | 74 Gy / 37 fractions (71.1%) or 78 Gy / 39 fractions (28.9%) ± 6 months of LHRH agonist with bicalutamide for 7 days | 12.2 years OS 74% woST-ADT 80% wST-ADT DM 27% woST-ADT 21% wST-ADT |  |
RTOG 0815 [13] | 1,492 IR men | 79.2 Gy / 44 fractions (89%) or 45 Gy / 25 fractions with brachytherapy boost (11%) ± 6 months of LHRH agonist with antiandrogen for 10 days | 8 years OS 79% woST-ADT 84% wST-ADT DM 4.3% woST-ADT 1.0% wST-ADT | − 67% having a single IR factor − 27% grade group 3 disease - excluded patients with more than two IR factors and ≥ 50% positive cores. |
DFCI 95–096 | 153 IR men | 70 Gy / 35 fractions ± 6 months of LHRH agonist with Flutamide | 7 years OS with no or mild comorbidity 86% woST-ADT 91% wST-ADT OS with moderate or severe comorbidity 28.5% wST-ADT 62.5% wST-ADT | - Use of Adult Comorbidity Evaluation 27 comorbidity scores (ACE-27). |
PCS III [28] | 400 IR men | 76 Gy / 38 fractions ± 6 months of LHRH agonist with bicalutamide | 10 years PCSM 6.5% woST-ADT 1.5% wST-ADT DM 10% woST-ADT 3.5%% wST-ADT | -78% UIR -contained another randomisation arm of 70 Gy / 35 fractions wST-ADT, 200 IR men. |