699 860
Table 5 – Ongoing prospective randomized trials comparing adjuvant and salvage radiotherapy (RT) in prostate cancer patients
Trial
Design
Arms
Population
Estimated
enrollment
Dose (median)
Type of RT
Primary
endpoints
Secondary endpoints
RADICALS RT
Randomized,
multicenter,
open-label
Immediate RT
vs early sRT
pT3/4 and/or pathologic
Gleason 7–10 and/or
preoperative PSA 10 ng/ml
and/or positive surgical
margins
1350 patients 66 Gy in
33 fractions or
52.5 in 20 fractions
RT to the
prostatic
bed pelvic
lymph nodes
Disease-specific
survival
Freedom from recurrence
Progression-free survival
Overall survival
Non-protocol ADT
Toxicity
Patient-reported outcomes
RADICALS HD
Randomized,
multicenter,
open-label
RT alone vs
RT + 6 mo ADT vs
RT + 12 mo ADT
Patients due to receive RT
2800 patients 66 Gy in 33 fractions
or 52.5 in 20 fractions
RT to the
prostatic
bed pelvic
lymph nodes
Disease-specific
survival
Freedom from recurrence
Progression-free survival
Overall survival
Non-protocol ADT
Toxicity
Patient-reported outcomes
RAVES
Randomized,
multicenter,
open-label
aRT vs early sRT Positive surgical margins and/
or extraprostatic extension
and/or seminal vesicle
invasion
470 patients 64 Gy in 32 fractions
IMRT or 3D-CRT
Target
volume and
treatment plan
centrally reviewed
Biochemical
failure
Toxicity and QoL
BCR-free survival
Overall survival
Disease-specific survival
Distant and local failure
Cost-utility
GETUG-17
Randomized,
multicenter,
open-label
aRT + ADT vs
early sRT + ADT
pT3R1 pN0 or pNx
718 patients 66 Gy in 33 fractions
3D-CRT
Progression-free
survival
Overall survival
Metastases-free survival
Toxicity and QoL
EORTC 22043-30041 Randomized,
multicenter,
open-label
aRT ADT vs
eSRT ADT
pT2R1 pN0 or pT3 pN0 with
undetectable PSA within 3 mo
from surgery
600 patients
a64–74 Gy
3D-CRT
BCR-free survival
Clinical progression-free survival
Distant metastases-free survival
Overall survival
QoL
Toxicity
ADT = androgen deprivation therapy; aRT = adjuvant radiotherapy; BCR = biochemical recurrence; IMRT = intensity-modulated radiotherapy; QoL = quality of life; sRT = salvage radiotherapy; 3D-CRT = three-dimensional
conformal radiotherapy.
a
Trial closed in 2013 for poor accrual.
E U R O P E A N U R O L O G Y 7 2 ( 2 0 1 7 ) 6 8 9 – 7 0 9
699