Very Long‐Term Complete Remission Can Be Achieved in Men With High‐Risk Localized Prostate Cancer and a Very High PSA Value: An Analysis of the GETUG 12 Phase 3 Trial - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue Clinical Genitourinary Cancer Année : 2023

Very Long‐Term Complete Remission Can Be Achieved in Men With High‐Risk Localized Prostate Cancer and a Very High PSA Value: An Analysis of the GETUG 12 Phase 3 Trial

Valentina Orlando
  • Fonction : Auteur
Gwénaëlle Gravis
Jean François Berdah
  • Fonction : Auteur
Jean Luc Labourey
  • Fonction : Auteur
Éric Legouffe
  • Fonction : Auteur
Jean Louis Davin
  • Fonction : Auteur
Anne Laure Martin
  • Fonction : Auteur
Meryem Brihoum
  • Fonction : Auteur

Résumé

Introduction: Serum prostate specific antigen (PSA) is a well-known prognostic parameter in men with prostate cancer. The treatment of men with very high PSA values and apparently no detectable metastases is not fully established. Patients and Methods: Ancillary analysis from the GETUG 12 phase 3 trial. Patients with non-metastatic high-risk prostate cancer by bone and computerized tomography (CT) scan were randomly assigned to receive androgen deprivation therapy (ADT) and docetaxel plus estramustine or ADT alone. Relapse-free survival (RFS), clinical RFS, metastases-free survival (MFS), overall survival (OS), and prostate cancer-specific survival (PCSS) were estimated using the Kaplan–Meier method for different levels of PSA (50 ng/mL, 75 ng/mL, and 100 ng/mL). The relationship between PSA and outcomes was studied using residual-based approaches and spline functions. Results: The median follow-up was 12 years (range: 0-15.3). Baseline PSA (<50 ng/mL, n = 328; ≥50ng/mL, n = 85) was associated with improved RFS (P = .0005), cRFS (P = .0024), and MFS (P = .0068). The 12-year RFS rate was 46.33% (CI 40.59-51.86), 33.59% (CI 22.55-44.97), and 11.76% (1.96-31.20) in men with PSA values <50 ng/mL (n = 328), 50-100 ng/mL (n = 68), and ≥100 ng/mL (n = 17), respectively. Exploratory analyses revealed no deviation from the linear relationship assumption between PSA and the log hazard of events. Conclusions: Men with apparently localized prostate cancer and a high baseline PSA value have a reasonable chance of being long-term disease-free when treated with curative intent combining systemic and local therapy.

Dates et versions

hal-04334564 , version 1 (11-12-2023)

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Valentina Orlando, Damien Drubay, Pernelle Lavaud, Laura Faivre, François Lesaunier, et al.. Very Long‐Term Complete Remission Can Be Achieved in Men With High‐Risk Localized Prostate Cancer and a Very High PSA Value: An Analysis of the GETUG 12 Phase 3 Trial. Clinical Genitourinary Cancer, 2023, 21 (5), pp.615.e1-615.e8. ⟨10.1016/j.clgc.2023.05.003⟩. ⟨hal-04334564⟩
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