. 2018 Jul 23;21(4):564–572. doi: 10.1038/s41391-018-0064-7

Table 5.

Results (biochemical disease-free survival): comparison with non-randomized studies using high-dose radiotherapy

Study	Study design	Inclusion criteria	Adjuvant therapy	no. of pts	Median follow-up months	Proportion with					bDFS
Study	Study design	Inclusion criteria	Adjuvant therapy	no. of pts	Median follow-up months	pN1	Preop. PSA > 10	Postop. PSA> 0.2	R1	Gleason score > 7	All pts	N0	N1	R0	R1
Cozzarini C et al., 2009	Retrosp.	pT3-4 R0/1; pT2 R1; pN0	RT: 55.8–72 Gy to prostatic fossa ± HT	334	108	0.0%	NO	NO	66.0%	16.2%	83.0% ( ≥ 70.2 Gy) 71.0% (<70.2 Gy) (5-y)	NO	NO	96.0% ( ≥ 70.2 Gy) 81.0% (<70.2 Gy) (98 pts hormone-naive)	86.0% ( ≥ 70.2 Gy) 82.0% (<70. 2 Gy) (64 pts hormone-naive)
Bellavita R et al., 2012	Retrosp.	pT3-4 R0/1; any T R1; pN0	RT: 50–70 Gy (1.8–2 Gy/fraction) to prostatic fossa ± region of seminal vesicles (only pT3b) ± HT	182	55.6	0.0%	NO	30.0%	75.0%	43.5%	87.0% (3-y) 81.0% (5-y) 75.0% 10-y)	NO	NO	NO	NO
Ost P et al., 2012	Retrosp.	pT3-4 R0/1; any T R1; pN0	RT: 70–77 Gy (1.8–2.0 Gy/fraction) to prostatic fossa ± HT	225	60	0.0%	40.0%	NO	72.0%	20.0%	84.0% (7-y)	NO	NO	77.0%	86.0%
Katayama S et al., 2014	Phase II	pT3 R0/1; pT2 R1; pN + ; postop PSA recurrence; Roach nodal risk > 20.0% with inadequate nodal dissection (<10)	RT: 68 Gy (2 Gy/fraction) to prostatic fossa ± PNI 51 Gy (1.5 Gy/fraction) + HT	40	24	57.5%	NO	NO	NO	70.0%	90% (2-y)	NO	NO	NO	NO
Present series	Phase II	≤ 79 y; ECOG scale 0–2; pT2-4 N0-1 M0	RT: 64.8–70.2 Gy (1.8 Gy/fraction) to prostatic fossa + PNI 45 Gy ± HT	123	67	14.6%	56.1%	7.3%	58.5%	25.2%	92.9% (5-y)	93.6%	90.0%	93.1%	92.9%

bDFS biochemical disease-free survival, preop preoperative, postop postoperative, y years, ECOG Eastern Cooperative Oncology Group, HT hormone therapy, NR not reported, PNI prophylactic irradiation, PSA prostate-specific antigen, pts number of patients, RT radiotherapy, Retrosp retrospective