Table 3: Randomized trials comparing LTAD and STAD with radiation in high-risk patients.

TrialStudy cohortMedian
follow-up
Trial armsOutcomes

EORTC 22961 [19]970 patients with T2c-T4 or N1-26.4 yearsRT + 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-T411.3 yearsRT + 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 patients6.5 yearsRT + 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.