| Study | n | Inclusion criteria |
Randomisation | Definition of BCR PSA (ng/ mL) |
Median FU (mo) |
Biochemical Progression-free survival |
OS |
|---|---|---|---|---|---|---|---|
| *See Section 6.3.5.1 for delayed (salvage) post-radical prostatectomy external irradiation. BCR = biochemical recurrence; FU = follow-up; mo = months; n = number of patients; n.s. = not significant; OS = overall survival; PSA = prostate-specific antigen; RP = radical prostatectomy; SM = surgical margin; SRT = salvage radiotherapy. | |||||||
| SWOG 8794 2009 «Thompson IM, Tangen CM, Paradelo J ym. Adjuvant ra...»1 |
431 | pT3 cN0 ± involved SM |
60–64 Gy vs. observation |
> 0.4 | 152 | 10 yr.: 53% vs. 30% (p < 0.05) |
10 yr.: 74% vs. 66% Median time: 15.2 vs. 13.3 yr., p = 0.023 |
| EORTC 22911 2012 «Bolla M, van Poppel H, Tombal B ym. Postoperative ...»2 |
1,005 | pT3 ± involved SM pN0 pT2 involved SM pN0 |
60 Gy vs. observation |
> 0.2 | 127 | 10 yr.: 60.6% vs. 41% (p < 0.001) |
81% vs. 77% n.s. |
| ARO 96-02 2014 «Wiegel T, Bartkowiak D, Bottke D ym. Adjuvant radi...»3 |
388 | pT3 (± involved SM) pN0 PSA post-RP undetectable |
60 Gy vs. observation |
> 0.05 + confirmation |
112 | 10 yr.: 56% vs. 35% (p = 0.0001) |
10 yr.: 82% vs. 86% n.s. |
| FinnProstate Group 2019 «Hackman G, Taari K, Tammela TL ym. Randomised Tria...»4 |
250 | pT2,R1/ pT3a |
66.6 Gy vs. observation (+SRT) |
> 0.4 (in 2 successive measurements) |
112 vs. 103 (patients alive) |
10 yr.: 82% vs. 61% p < 0.001 |
10 yr.: 92% vs. 87% n.s. |