Table 2.
Randomized trials examining the addition of ADT to radiation for high-risk patients.
| Trial | Study cohort | Median follow-up |
Trial arms | Outcomes |
|---|---|---|---|---|
| RTOG 85-31 [11, 12] | 945 patients T3 (82%) or N1 (18%) | 7.6 years | RT versus RT + ADT (44–46 Gy to whole pelvis; 20–25 Gy boost to prostate) ADT: goserelin at least 2 years, preferably until progression |
10-year OS (39% versus 49%, p = 0.002) 10-year DSS (78% versus 84%, p = 0.005) Overall survival benefit limited to patients with Gleason 7–10 |
|
| ||||
| RTOG 86-10 [13–15] | 456 patients T2-T4, N0-1 with “bulky” disease (palpable ≥ 25 cm2) | 11.9 years | RT versus RT + ADT (44–46 Gy to whole pelvis; 20–25 Gy boost to prostate) ADT: 4 months' goserelin + flutamide, starting 2 months prior to RT |
10-year OS (34% versus 43%, p = 0.12) 10-year DSS (23% versus 36%, p = 0.01) Subset analyses at 8 years showed that benefit was confined to Gleason 2–6 patients. No benefit to ADT in Gleason 7–10 |
|
| ||||
| TROG 96-01 [16] | 802 patients T2b-T4N0 |
10.6 years | RT alone versus RT + 3 mo. ADT versus RT + 6 mo. (66 Gy, no pelvic node treatment) ADT: goserelin + flutamide given neoadjuvantly |
At 10 years, addition of 6 months' ADT improved 10-year OS (70.8% versus 57.5%, p = 0.0005) 10-year DSS (48% versus 23%, p < 0.0001) |
|
| ||||
| EORTC 22863 [17, 18] |
415 patients T1-2N0 grade 3 or T3-4N0-1 |
9.1 years | RT versus RT + 3 years' ADT (50 Gy to pelvis, 20 Gy boost) ADT: 1 month' cyproterone acetate, goserelin × 3 years starting with RT |
10-year OS (40% versus 58%, p = 0.0004) 10-year DSS (10% versus 30%, p < 0.0001) |
OS: overall survival, DSS: disease-specific survival.