Table 1: Characteristics of randomized trials on immediate adjuvant RT.

TrialSWOG 8794EORTC 22911ARO 96-02

Year of initiation198819921996
Pats.
 Randomized
 Eligible
 Percent
 Median age
431
425
98.6%
64.5 years
1005
968
96.3%
65 years
307 from 385 selected
266
87.3%
64 years

Inclusion criteriacT1-2, post-RP:
Extraprostatic extension and/or seminal vesicle invasion and/or positive resection margins
Extraprostatic extension and/or seminal vesicle invasion and/or positive resection marginscT1-3, post-RP:
Extraprostatic extension and/or seminal vesicle invasion
pT3 and/or R1, c/p N0 (97% pelvic LN-dissection) cM0pT2 R1 or pT3 R0-1, c/p N0 (99% pN0) cM0pT3-4 R0-1 pN0 cM0
SWOG PS 0–2
Age not reported
WHO PS 0-1
Age <76 years
WHO PS 0-1
Age <76 years

Postop. PSA<0.2 ng/mL: 66.2 %
≥0.2 ng/mL: 33.8 %
≤0.2 ng/mL: 88.7%
>0.2 ng/mL: 10.7%
Unknown: 0.6%
<0.1 ng/mL: 100%

StratificationPositive margins or capsule invasion versus invasion of seminal vesicles versus positive margins and capsule invasion; HTInstitution; capsule invasion; positive margins; invasion of the seminal vesiclesGleason Score; resection margins; neoadjuvant HT; tumor stage

Hormonal therapy8.5%10.0%11.5%
Adjuvant RT30–32 × 2.0 Gy30 × 2.0 Gy (in 90.8%)30 × 2.0 Gy (in 82%)
Time from RP to RT<18 weeks<16 weeks10–30 weeks

Treatment in observation armRT: 33.2%RT: 22.5%
HT: 9.1%
Other: 1%
Not reported

Median followup12.6 years5 years4.5 years

Primary endpointMetastasis-free survival (bone, visceral, extrapelvic lymph nodes)Biochemical progression-free survivalProgression-free survival

Definition of bNED ng/mL for postop. ng/mL ng/mL above lowest postop. PSA2 increasing PSA values

bNED: biological no evidence of disease; RP: radical prostatectomy; RT: radiotherapy; HT: hormonal therapy; PS: performance status.