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.

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.

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.

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.

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.

Clinical genitourinary cancer. 2023 May 07 [Epub ahead of print]

Valentina Orlando, Damien Drubay, Pernelle Lavaud, Laura Faivre, François Lesaunier, Remy Delva, Gwenaëlle Gravis, Frédéric Rolland, Frank Priou, Jean-Marc Ferrero, Nadine Houede, Loic Mourey, Christine Theodore, Ivan Krakowski, Jean-François Berdah, Marjorie Baciuchka, Brigitte Laguerre, Aude Fléchon, Marine Grosse-Goupil, Isabelle Cojean-Zelek, Stéphane Oudard, Jean-Luc Labourey, Paule Chinet-Charrot, Eric Legouffe, Jean-Léon Lagrange, Claude Linassier, Gaël Deplanque, Philippe Beuzeboc, Jean-Louis Davin, Anne-Laure Martin, Meryem Brihoum, Stéphane Culine, Gwénaël Le Teuff, Karim Fizazi

Department of Oncology, Ospedale Maggiore, Trieste, Italy. Electronic address: ., Department of Biostatistics and Epidemiology, Gustave Roussy, University Paris-Saclay, Villejuif, France; Oncostat U1018, Inserm, University Paris-Saclay, labeled Ligue Contre le Cancer, Villejuif, France., Department of cancer medicine, Institut Gustave Roussy, University of Paris Saclay, Villejuif, France., Department of Biostatistics and Epidemiology, Gustave Roussy, University Paris-Saclay, Villejuif, France., Département Médico-technique, Centre François Baclesse, Caen, France., Institut de Cancérologie de l'Ouest, Angers, France., Department of Medical Oncology, Institut Paoli Calmettes, Marseille, France., Department of Medical Oncology, Institut de Cancérologie de l'Ouest, Nantes, France., Department of Medical Oncology, Centre Hospitalier Départemental, La Roche-sur-Yon, France., Department of Medical Oncology, Centre Antoine Lacassagne, Nice, France., Department of Medical Oncology, Centre Hospitalier de Nimes, Nimes, France., Department of Medical Oncology, Institut Claudius Regaud, Toulouse, France., Department of Medical Oncology, Hôpital Foch, Paris, France., Department of Medical Oncology, Centre Alexis Vautrin, Nancy, France., Department of Medical Oncology, Castelluccio Hospital, Ajaccio, France., Multidisciplinary Oncology and Therapeutic Innovations Department, Assistance Publique-Hôpitaux de Marseille (AP-HM), Marseille, France., Department of Medical Oncology, Centre Eugène Marquis, Rennes, France., Department of Medical Oncology, Centre Léon Bérard, Lyon, France., Department of Medical Oncology, Hôpital Saint-André, Bordeaux, France., Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France., Department of Medical Oncology, Hôpital Européen Georges Pompidou, Paris, France., Department of Oncology, Hôpital de Carcassonne, Carcasonne, France., Department of Oncology, Centre Henri Becquerel, Rouen, France., Department of Medical Oncology, Clinique Valdegour, Nîmes, France., Department of Radiation Oncology, Hopital Henri Mondor, Université Paris Est Creteil, Créteil, France., Department of Medical Oncology, Hôpital Bretonneau, Tours, France., Department of Oncology, Lausanne University Hospital, Lausanne, Swiss., Oncology and Supportive Care Department, Foch Hospital, Suresnes, France., Clinique Sainte-Catherine, Avignon, France., Unicancer, Paris, France., Department of Medical Oncology, Hôpital Saint-Louis, Paris, France.