Overview of all four randomised trials for adjuvant surgical bed radiation therapy after RP
Additional information
16.4.2025
| 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 radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized »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 radiotherapy after radical prostatectomy for high-risk prostate cancer: long-term results of a randomised controlled trial (EORTC trial 22911). Lancet»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 radiotherapy versus wait-and-see after radical prostatectomy: 10-year follow-up of the ARO 96-02/AUO AP 09/95 trial. Eur Urol 2014;66:243-50 »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 Trial of Adjuvant Radiotherapy Following Radical Prostatectomy Versus Radical Prostatectomy Alone in Prostate Cancer Patients with Positive Margins or Ext»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. |
References
- Thompson IM, Tangen CM, Paradelo J ym. Adjuvant radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized clinical trial. J Urol 2009;181:956-62 «PMID: 19167731»PubMed
- Bolla M, van Poppel H, Tombal B ym. Postoperative radiotherapy after radical prostatectomy for high-risk prostate cancer: long-term results of a randomised controlled trial (EORTC trial 22911). Lancet 2012;380:2018-27 «PMID: 23084481»PubMed
- Wiegel T, Bartkowiak D, Bottke D ym. Adjuvant radiotherapy versus wait-and-see after radical prostatectomy: 10-year follow-up of the ARO 96-02/AUO AP 09/95 trial. Eur Urol 2014;66:243-50 «PMID: 24680359»PubMed
- Hackman G, Taari K, Tammela TL ym. Randomised Trial of Adjuvant Radiotherapy Following Radical Prostatectomy Versus Radical Prostatectomy Alone in Prostate Cancer Patients with Positive Margins or Extracapsular Extension. Eur Urol 2019;76:586-595 «PMID: 31375279»PubMed