Pommier (GETUG-01) [24] | 1998-2004 | 444 | T1b-T3, N0 pNx, M0 21%- low risk (<15%- Roach) | 4 - 8 months NHT, plus concurrent ADT mandatory for high risk | Prostate and pelvis 66 - 70 Gy to the prostate and SV, 44 - 46 Gy to the pelvis | No difference between pelvic and PO RT 10-year OS (74.9% vs 73.6%), or EFS (57.6% vs 55.6%) |
Mottet [36] | 2000-2003 | 264 | T3-4 or pT3N0M0 | 3yrs ADT | Prostate and pelvis 68 - 70 Gy to the prostate and SV, 46 Gy to pelvic nodes | 5 year PFS in favour of ADT + RT vs ADT alone (64.7% vs 15.4%,p < 0.001) |
Blanchard (GETUG-12) [26] | 2002-2006 | 413 | At least 1 of the following high-risk features: Gleason score > 8, stage T3 or T4 disease, serum PSA concentration >20 ng/mL or pN+ | 3 years ADT plus 4 cycles of Docetaxel Estramustine | Prostate (n-208) 74 Gy-prostate and SV Prostate and pelvis (n-150) 74 Gy-prostate and SV 46 - 50 Gy to the pelvis | Median follow-up was 8.8 years. No association between bPFS and use of pelvic ENI in multivariate analysis (HR: 1.10 [95% CI: 0.78 - 1.55], p = .60), even when analysis was restricted to pN0 patients (HR: 0.88 [95% CI: 0.59 - 1.31], p = .53) |
Morris (ASCENDE-RT) [27] | 2004-2011 | 398 | At least 1 of the following high-risk features: Gleason score >8, serum PSA concentration > 20 ng/mL Excluded if T3b or greater, N1, or PSA > 40 | 12 months ADT | Prostate and pelvis EBRT 46 Gy to pelvis then randomized to receive DE-EBRT-78 Gy or LDR-PB | At median follow-up 6.5 years DE-EBRT twice as likely to experience biochemical failure HR 2.04 Estimated 5, 7, 9 year bPFS-89%, 86%, 83% (LDR-PB) vs 84%, 75% 62% (DE-EBRT) respectively |