title: Postoperative radiotherapy after radical prostatectomy: a randomised controlled trial (EORTC trial 22911).
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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Radiation Oncology, Centre Hospitalier Universitaire A Michallon, Grenoble, France. MBolla@chu-grenoble.fr
authors.forename: Michel
authors.initials: M
authors.lastname: Bolla
authors.forename: Hein
authors.initials: H
authors.lastname: van Poppel
authors.forename: Laurence
authors.initials: L
authors.lastname: Collette
authors.forename: Paul
authors.initials: P
authors.lastname: van Cangh
authors.forename: Kris
authors.initials: K
authors.lastname: Vekemans
authors.forename: Luigi
authors.initials: L
authors.lastname: Da Pozzo
authors.forename: Theo M
authors.initials: TM
authors.lastname: de Reijke
authors.forename: Antony
authors.initials: A
authors.lastname: Verbaeys
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Bosset
authors.forename: Roland
authors.initials: R
authors.lastname: van Velthoven
authors.forename: Jean-Marie
authors.initials: JM
authors.lastname: Maréchal
authors.forename: Pierre
authors.initials: P
authors.lastname: Scalliet
authors.forename: Karin
authors.initials: K
authors.lastname: Haustermans
authors.forename: Marianne
authors.initials: M
authors.lastname: Piérart
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D000368:Aged; D003131:Combined Modality Therapy; D018450:Disease Progression; D006801:Humans; D008297:Male; D008875:Middle Aged; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D015996:Survival Rate