|
| Trial | SWOG 8794 | EORTC 22911 | ARO 96-02 |
|
| Year of initiation | 1988 | 1992 | 1996 |
| 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 criteria | cT1-2, 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 margins | cT1-3, post-RP:
Extraprostatic extension and/or seminal vesicle invasion |
| pT3 and/or R1, c/p N0 (97% pelvic LN-dissection) cM0 | pT2 R1 or pT3 R0-1, c/p N0 (99% pN0) cM0 | pT3-4 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% |
|
| Stratification | Positive margins or capsule invasion versus invasion of seminal vesicles versus positive margins and capsule invasion; HT | Institution; capsule invasion; positive margins; invasion of the seminal vesicles | Gleason Score; resection margins; neoadjuvant HT; tumor stage |
|
| Hormonal therapy | 8.5% | 10.0% | 11.5% |
| Adjuvant RT | 30–32 × 2.0 Gy | 30 × 2.0 Gy (in 90.8%) | 30 × 2.0 Gy (in 82%) |
| Time from RP to RT | <18 weeks | <16 weeks | 10–30 weeks |
|
| Treatment in observation arm | RT: 33.2% | RT: 22.5%
HT: 9.1%
Other: 1% | Not reported |
|
| Median followup | 12.6 years | 5 years | 4.5 years |
|
| Primary endpoint | Metastasis-free survival (bone, visceral, extrapelvic lymph nodes) | Biochemical progression-free survival | Progression-free survival |
|
| Definition of bNED | ng/mL for postop. ng/mL | ng/mL above lowest postop. PSA | 2 increasing PSA values |
|
