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Genitourinary tumours, prostate

2161 - Modelling relapse in patients with high-risk localised prostate cancer treated randomly in the GETUG 12 phase III trial reveals two populations of relapsing patients


09 Oct 2016


Genitourinary tumours, prostate


Cécile Vicier


Annals of Oncology (2016) 27 (6): 243-265. 10.1093/annonc/mdw372


C. Vicier1, L. Faivre2, F. Lesaunier3, R. Delva4, G. Gravis5, F. Rolland6, F. Priou7, J. Ferrero8, N. Houede9, L. Mourey10, C. Theodore11, I. Krakowski12, J. Berdah13, M. Baciuchka14, B. Laguerre15, A. Flechon16, S. Oudard17, M. Habibian18, S. Culine19, K. Fizazi20

Author affiliations

  • 1 Cancer Medicine, Institut de Cancérologie Gustave Roussy, 94800 - Villejuif/FR
  • 2 Biostatitics And Epidemiology, Institut Gustave Roussy, Villejuif/FR
  • 3 Medical Oncology, Centre Francois Baclesse, Caen/FR
  • 4 Medical Oncology, Centre Paul Papin, Angers/FR
  • 5 Medical Oncology, Institute Paoli Calmettes, Marseille/FR
  • 6 Medical Oncology, CHU de Nantes, Nantes/FR
  • 7 Medical Oncology, CHD Vendee - Hopital Les Oudairies, La Roche sur Yon/FR
  • 8 Medical Oncology, Centre Antoine Lacassagne, Nice/FR
  • 9 Medical Oncology, CHU Nimes, Caremeau, Nimes/FR
  • 10 Medical Oncology, Centre Claudius-Regaud, Toulouse/FR
  • 11 Medical Oncology, Hopital Foch Service d'Oncologie, Suresnes/FR
  • 12 Medical Oncology, Centre Alexis Vautrin, Nancy/FR
  • 13 Medical Oncology, Clinique Sainte-Marguerite, Hyeres/FR
  • 14 Medical Oncology, CHU La Timone Adultes, Marseille/FR
  • 15 Medical Oncology, Centre Eugene - Marquis, Rennes/FR
  • 16 Medical Oncology, Centre Léon Bérard, Lyon/FR
  • 17 Medical Oncology, Hopital European George Pompidou, Paris/FR
  • 18 Research And Development, UNICANCER, Paris/FR
  • 19 Medical Oncology, Hôpital St. Louis, Paris/FR
  • 20 Cancer Medicine, Institut de Cancérologie Gustave Roussy, Villejuif/FR


Abstract 2161


The patterns of relapse in patients with high-risk prostate cancer treated with modern therapy are poorly described. In the present study, we aimed to analyse the patterns of relapse in the randomized phase III trial Groupe d'Etude des Tumeurs Uro-Genitales 12 (GETUG 12) in patients with high-risk localised prostate cancer.


Patients were enrolled and randomly assigned to receive either androgen deprivation therapy (ADT) with goserelin every 3 months for 3 years combined upfront with 4 cycles of docetaxel and estramustine (ADT + DE) or ADT alone, plus local therapy. We analysed the pattern of second event-free-survival (PFS2) in patients with biochemical progression (bPFS). Adjusting factors were stratification factors (T stage, Gleason score, baseline PSA, and pN status) and treatment.


413 patients were randomized from 2002 to 2006, 206 treated with ADT alone and 207 with ADT + DE. Median follow-up was 8.8 years (IQR: 8.1-9.7). A total of 130 patients exhibited biochemical relapse, with a median bPFS of 5 years (range: 0.23-10.4) for relapsing patients. 77/130 patients subsequently developed a second event: metastatic progression (53), clinical progression (13) and death (7). The analysis of relapsing patients revealed the following data: 1) the median time from biochemical failure to a clinical event was 2 years [95% CI: 1.07 – 2.91]; 2) biochemical relapses were rare (n = 27; 21%) within the first 3 years (


This analysis of the GETUG 12 trial demonstrates that overall, a clinical event is to be expected, with a median time of 2 years in patients with high-risk localised prostate cancer who develop a biochemical relapse, and that the timing of this relapse is highly prognostic with twice as many clinical events likely to occur in patients relapsing within the first 3 years.

Clinical trial identification

GETUG 12: ClinicalTrials.gov NCT00055731

Legal entity responsible for the study

Institut Gustave Roussy




A. Flechon: Sanofi. S. Oudard: Sanofi, Bayer, Astellas, Janssen. K. Fizazi: Participation to advisory boards and honorarium: Sanofi. All other authors have declared no conflicts of interest.

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