Evolving Paradigm of Radiotherapy for High-Risk Prostate Cancer: Current Consensus and Continuing Controversies

Table 3

Randomized trials comparing LTAD and STAD with radiation in high-risk patients.

Trial	Study cohort	Median; follow-up	Trial arms	Outcomes
EORTC 22961 [19]	970 patients with T2c-T4 or N1-2	6.4 years	RT + 6 months’ ADT versus RT + 36 months’ ADT; (Prostate dose 70 Gy); ADT: 6 months’ CAB (LHRH agonist + antiandrogen) 2.5 years’ LHRH agonist	5-year OS 81% versus 85% (); 5-year DSS 95% versus 97% (); QOL measures the same in each arm; No difference in cardiac fatal event Increased rates of reported gynecomastia, incontinence, and sexual dysfunction with LTAD
RTOG 92-02 [20, 21]	1514 patients with T2c-T4	11.3 years	RT + 4 months’ ADT versus RT + 28 months’ ADT; (44–50 Gy to whole pelvis, boost to 65–70 Gy prostate); ADT: goserelin + flutamide 4 months total (prior to and during RT) 2 years’ goserelin	10-year OS 52% versus 54% (); 10-year DSS 84% versus 89% (); Gleason 8–10 subset: 10-year OS 32% versus 45% (); Increased grade 3 GI toxicity at 8 years with LTAD (2.9% versus 1.2%, )
DART 01/05; Spain [22]	355 patients (47% int.-risk, 53% high-risk)	5.3 years	RT + 4 months’ ADT versus RT + 28 months’ ADT; (76–82 Gy to prostate); ADT: goserelin + antiandrogen for 4 months total (prior to and during RT) 2 years’ goserelin	5-year OS 86% versus 95% (); 5-year BRFS 81% versus 89% (); 5-year metastasis-free survival 83% versus 94% ()
PCS IV Trial; Canada; Nabid et al. [23]	630 node-negative, high-risk patients	6.5 years	RT + 18 months’ ADT versus RT + 36 months’ ADT; (44 Gy to whole pelvis, 70 Gy to prostate); ADT: bicalutamide 1 month, goserelin q 3 months for 18 or 36 months	10-year OS 59% versus 62% (); 10-year DSS 84.1% versus 83.7% ()

LTAD: long-term ADT, STAD: short-term ADT, OS: overall survival, DSS: disease-specific survival, and BRFS: biochemical relapse-free survival.