Article Dans Une Revue European Urology Oncology Année : 2026

Results of the Randomized Phase 3 AFU-GETUG-20 Trial Evaluating Adjuvant Leuprorelin Acetate After Radical Prostatectomy in Men with High-risk Localized Prostate Cancer

Alain Ruffion
Gregoire Robert
  • Fonction : Auteur
  • PersonId : 1086024
Jochen Walz
  • Fonction : Auteur
Alexandre de La Taille
  • Fonction : Auteur
  • PersonId : 851748
Laurent Salomon
Christian Pfister-Langanay
  • Fonction : Auteur
  • PersonId : 1608728
  • IdRef : 089889819
Sebastien Vincendeau
  • Fonction : Auteur
Aurelien Descazaud
  • Fonction : Auteur
Igor Latorzeff
  • Fonction : Auteur
  • PersonId : 949033
Laurent Brureau
Marc Colombel
Morgan Rouprêt
  • Fonction : Auteur
  • PersonId : 1003501
Lise Roca
  • Fonction : Auteur
Christelle Perez
  • Fonction : Auteur
Sébastien Marion
  • Fonction : Auteur
Eric Barret
Stéphane Culine

Résumé

BACKGROUND AND OBJECTIVE: Androgen-deprivation therapy survival benefits after radical prostatectomy (RP) in nonmetastatic high-risk prostate cancer (PCa) patients with an undetectable prostate-specific antigen (PSA) level are unclear. The AFU-GETUG-20 study assessed the benefit of leuprorelin immediately after RP in this population. METHODS: This open-label, randomized, phase 3 trial is conducted at 37 French centers. Participants undergoing RP for nonmetastatic PCa were aged ≥18 yr, with a postoperative Gleason score of ≥7 and PSA <0.1 ng/ml. Participants were randomly assigned (1:1) to the observation or leuprorelin (45 mg subcutaneous Q6M, 24 mo) arm. The primary endpoint was metastasis-free survival in the intent-to-treat population (n = 322). The secondary objectives PSA and testosterone level evolution, PCa-specific survival, overall survival, safety, and quality of life. KEY FINDINGS AND LIMITATIONS: From 2011 to 2017, 325 patients were randomized to the observation (n = 163) or leuprorelin (n = 162) arm. The 10-yr risk of metastasis occurrence was similar between arms (hazard ratio [HR] 0.63 [95% confidence interval {CI} 0.30-1.30]; p = 0.204) with no differences in PSA rise-free survival (HR 0.74 [95% CI 0.47-1.16]; p = 0.187), overall survival (HR 1.24 [95% CI 0.56-2.76]; p = 0.596), or PCa-specific survival (HR 0.57 [95% CI 0.10-3.17]; p = 0.512). Leuprorelin-treated patients had lower testosterone level after surgery (p < 0.001), shorter time to global health degradation (p = 0.0019), fatigue (p < 0.001), pain (p < 0.001), and additional adverse events, mainly hot flashes (83.6% vs 6.2%), pain (57.2% vs. 17.1%), fatigue (45.4% vs 16.3%), and psychiatric disorders (25.0% vs 2.3%). Insufficient enrollment affected the trial power but permitted pertinent comparison. CONCLUSIONS AND CLINICAL IMPLICATIONS: Leuprorelin treatment immediately after RP in high-risk nonmetastatic PCa patients with an undetectable PSA level does not improve survival, but increases adverse events, leading to poorer quality of life compared with observation.

Fichier non déposé

Dates et versions

hal-05456425 , version 1 (13-01-2026)

Identifiants

Citer

François Rozet, Alain Ruffion, Pablo Lemercier, Michel Soulié, Gregoire Robert, et al.. Results of the Randomized Phase 3 AFU-GETUG-20 Trial Evaluating Adjuvant Leuprorelin Acetate After Radical Prostatectomy in Men with High-risk Localized Prostate Cancer. European Urology Oncology, 2026, ⟨10.1016/j.euo.2025.11.009⟩. ⟨hal-05456425⟩
47 Consultations
0 Téléchargements

Altmetric

Partager

  • More