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.
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.
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.
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.
European urology oncology. 2026 Jan 03 [Epub ahead of print]
François Rozet, Alain Ruffion, Pablo Lemercier, Michel Soulié, Gregoire Robert, Jochen Walz, Alexandre De La Taille, Laurent Salomon, Christian Pfister, Romain Mathieu, Sebastien Vincendeau, Aurelien Descazaud, Igor Latorzeff, Laurent Brureau, Marc Colombel, Morgan Rouprêt, Lise Roca, Christelle Pérez, Sebastien Marion, Eric Barret, Xavier Cathelineau, Karim Fizazi, Stephane Culine, GETUG-20 Investigators
Department of Urology, Institut Mutualiste Montsouris, Paris, France. Electronic address: ., Department of Urology, Lyon Sud Hospital, Lyon, France., Department of Biometrics, Institut du Cancer de Montpellier, Montpellier, France., Department of Urology, University Hospital Rangueil, Centre Hospitalier Universitaire de Toulouse, Toulouse, France., Department of Urology, Hospital Pellegrin, Bordeaux, France., Department of Urology, Institut Paoli-Calmettes Cancer Center, Marseille, France., Department of Urology, Centre Hospitalier Universitaire Henri Mondor, Créteil, France., Department of Urology, Hôpital Henri Mondor, Créteil, France., Department of Urology, Rouen University Hospital, Rouen, France., Department of Urology, Centre Hospitalier Universitaire de Rennes, Rennes, France., Centre Hospitalier Privé St Grégoire, Saint Grégoire, France., Department of Urology, Centre Hospitalier Universitaire de Limoges, Limoges, France., Department of Radiation-Oncology, Clinique Pasteur, Toulouse, France., Department of Urology, Centre Hospitalier Universitaire de Pointe-à-Pitre, Pointe-à-Pitre, France., Department of Urology and Transplantation Surgery, Hospital Edouard Herriot, Lyon, France., Department of Urology, Pitié-Salpétrière Hospital, Sorbonne University, Paris, France., R&D Department, Unicancer, Kremlin-Bicêtre, France., Department of Urology, Institut Mutualiste Montsouris, Paris, France., Institut Gustave Roussy, Centre Oscar Lambret, University of Paris Saclay, Villejuif, France., Department of Medical Oncology, Faculté Paris Cité, Hospital Saint-Louis, AP-HP, Paris, France.
PubMed http://www.ncbi.nlm.nih.gov/pubmed/41486043