title: Adjuvant radiotherapy versus wait-and-see after radical prostatectomy: 10-year follow-up of the ARO 96-02/AUO AP 09/95 trial.
abstract: BACKGROUND
  Local failure after radical prostatectomy (RP) is common in patients with cancer extending beyond the capsule. Three prospectively randomized trials demonstrated an advantage for adjuvant radiotherapy (ART) compared with a wait-and-see (WS) policy.
  
  
  OBJECTIVE
  To determine the efficiency of ART after a 10-yr follow-up in the ARO 96-02 study.
  
  
  METHODS
  After RP, 388 patients with pT3 pN0 prostate cancer (PCa) were randomized to WS or three-dimensional conformal ART with 60 Gy. The present analysis focuses on intent-to-treat patients who achieved an undetectable prostate-specific antigen after RP (ITT2 population)--that is, 159 WS plus 148 ART men.
  
  
  METHODS
  The primary end point of the study was progression-free survival (PFS) (events: biochemical recurrence, clinical recurrence, or death). Outcomes were compared by log-rank test. Cox regression analysis served to identify variables influencing the course of disease.
  
  
  CONCLUSIONS
  The median follow-up was 111 mo for ART and 113 mo for WS. At 10 yr, PFS was 56% for ART and 35% for WS (p<0.0001). In pT3b and R1 patients, the rates for WS even dropped to 28% and 27%, respectively. Of all 307 ITT2 patients, 15 died from PCa, and 28 died for other or unknown reasons. Neither metastasis-free survival nor overall survival was significantly improved by ART. However, the study was underpowered for these end points. The worst late sequelae in the ART cohort were one grade 3 and three grade 2 cases of bladder toxicity and two grade 2 cases of rectum toxicity. No grade 4 events occurred.
  
  
  CONCLUSIONS
  Compared with WS, ART reduced the risk of (biochemical) progression with a hazard ratio of 0.51 in pT3 PCa. With only one grade 3 case of late toxicity, ART was safe.
  
  
  RESULTS
  Precautionary radiotherapy counteracts relapse after surgery for prostate cancer with specific risk factors.
authors.affiliation: Department of Radiation Oncology, University Hospital Ulm, Ulm, Germany. Electronic address: thomas.wiegel@uniklinik-ulm.de.
authors.forename: Thomas
authors.initials: T
authors.lastname: Wiegel
authors.affiliation: Department of Radiation Oncology, University Hospital Ulm, Ulm, Germany.
authors.forename: Detlef
authors.initials: D
authors.lastname: Bartkowiak
authors.affiliation: Department of Radiation Oncology, University Hospital Ulm, Ulm, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Bottke
authors.affiliation: Department of Radiation Oncology, University Hospital Ulm, Ulm, Germany.
authors.forename: Claudia
authors.initials: C
authors.lastname: Bronner
authors.affiliation: Department of Urology, Charité Universitätsmedizin, Campus Benjamin- Franklin, Berlin, Germany.
authors.forename: Ursula
authors.initials: U
authors.lastname: Steiner
authors.affiliation: Department of Radiation Oncology, Charité Universitätsmedizin, Campus Benjamin- Franklin, Berlin, Germany.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Siegmann
authors.affiliation: Department of Pathology, Helios-Clinic Wuppertal, Wuppertal, Germany.
authors.forename: Reinhard
authors.initials: R
authors.lastname: Golz
authors.affiliation: Department of Pathology, Helios-Clinic Wuppertal, Wuppertal, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Störkel
authors.affiliation: Department of Radiation Oncology, University Hospital Münster, Münster, Germany.
authors.forename: Normann
authors.initials: N
authors.lastname: Willich
authors.affiliation: Department of Urology, University Hospital Münster, Münster, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Semjonow
authors.affiliation: Department of Urology, University Hospital Homburg/Saar, Homburg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Stöckle
authors.affiliation: Department of Radiation Oncology, University Hospital Homburg/Saar, Homburg, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Rübe
authors.affiliation: Department of Urology, Diakonissen-Krankenhaus Dessau, Dessau-Rosslau, Germany.
authors.forename: Udo
authors.initials: U
authors.lastname: Rebmann
authors.affiliation: Department of Urology, General Hospital Fulda, Fulda, Germany.
authors.forename: Tilman
authors.initials: T
authors.lastname: Kälble
authors.affiliation: Department of Radiation Oncology, General Hospital Fulda, Fulda, Germany.
authors.forename: Horst Jürgen
authors.initials: HJ
authors.lastname: Feldmann
authors.affiliation: Department of Urology, University Hospital Dresden, Dresden, Germany.
authors.forename: Manfred
authors.initials: M
authors.lastname: Wirth
authors.affiliation: Departments of Urology, University Hospital Giessen-Marburg, Marburg, Germany.
authors.forename: Rainer
authors.initials: R
authors.lastname: Hofmann
authors.affiliation: Department of Radiation Oncology, University Hospital Giessen-Marburg, Marburg, Germany.
authors.forename: Rita
authors.initials: R
authors.lastname: Engenhart-Cabillic
authors.affiliation: WiSP GmbH, Langenfeld, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Hinke
authors.affiliation: Department of Radiation Oncology, Charité Universitätsmedizin, Campus Benjamin- Franklin, Berlin, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Hinkelbein
authors.affiliation: Department of Urology, Charité Universitätsmedizin, Campus Benjamin- Franklin, Berlin, Germany.
authors.forename: Kurt
authors.initials: K
authors.lastname: Miller
mesh_terms: D000230:Adenocarcinoma / Q000097:blood / Q000473:pathology* / Q000628:therapy*; D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D018450:Disease Progression; D018572:Disease-Free Survival; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D018365:Neoplasm, Residual; D017430:Prostate-Specific Antigen / Q000097:blood; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000097:blood / Q000473:pathology* / Q000628:therapy*; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects; D016879:Salvage Therapy; D015996:Survival Rate; D013997:Time Factors; D057832:Watchful Waiting
chemical_list: D018931:Antineoplastic Agents, Hormonal; D017430:Prostate-Specific Antigen
keywords: Adjuvant radiotherapy; Prostate cancer; Prostate-specific antigen; Radical prostatectomy; Wait-and-see