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Title: Postoperative radiotherapy after radical prostatectomy: a randomised controlled trial (EORTC trial 22911)
Authors: Bolla, Michel ×
Van Poppel, Hendrik
Collette, Laurence
van Cangh, Paul
Vekemans, Kris
Da Pozzo, Luigi
de Reijke, Theo M
Verbaeys, Antony
Bosset, Jean-François
van Velthoven, Roland
Maréchal, Jean-Marie
Scalliet, Pierre
Haustermans, Karin
Piérart, Marianne #
Issue Date: Aug-2005
Series Title: Lancet vol:366 issue:9485 pages:572-578
Abstract: BACKGROUND: Local failure after prostatectomy can arise in patients with cancer extending beyond the capsule. We did a randomised controlled trial to compare radical prostatectomy followed by immediate external irradiation with prostatectomy alone for patients with positive surgical margin or pT3 prostate cancer. METHODS: After undergoing radical retropubic prostatectomy, 503 patients were randomly assigned to a wait-and-see policy, and 502 to immediate postoperative radiotherapy (60 Gy conventional irradiation delivered over 6 weeks). Eligible patients had pN0M0 tumours and one or more pathological risk factors: capsule perforation, positive surgical margins, invasion of seminal vesicles. Our revised primary endpoint was biochemical progression-free survival. Analysis was by intention to treat. FINDINGS: The median age was 65 years (IQR 61-69). After a median follow-up of 5 years, biochemical progression-free survival was significantly improved in the irradiated group (74.0%, 98% CI 68.7-79.3 vs 52.6%, 46.6-58.5; p<0.0001). Clinical progression-free survival was also significantly improved (p=0.0009). The cumulative rate of locoregional failure was significantly lower in the irradiated group (p<0.0001). Grade 2 or 3 late effects were significantly more frequent in the postoperative irradiation group (p=0.0005), but severe toxic toxicity (grade 3 or higher) were rare, with a 5-year rate of 2.6% in the wait-and-see group and 4.2% in the postoperative irradiation group (p=0.0726). INTERPRETATION: Immediate external irradiation after radical prostatectomy improves biochemical progression-free survival and local control in patients with positive surgical margins or pT3 prostate cancer who are at high risk of progression. Further follow-up is needed to assess the effect on overall survival.
URI: 
ISSN: 0140-6736
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Urology Section (-)
Laboratory of Experimental Radiotherapy
× corresponding author
# (joint) last author

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