Patients with Prostate Imaging Reporting and Data System (PI-RADS) 5 lesions are at a high risk of clinically significant prostate cancer (PCa), extracapsular extension, and biochemical recurrence (BCR) after local treatment. Managing these patients with active surveillance (AS) can be particularly challenging when targeted biopsies indicate favorable-risk tumors. This study aims to evaluate the outcomes of patients with PI-RADS 5 lesions managed with AS.
We analyzed data from 126 patients treated at 16 centers in France, Italy, Switzerland, and Belgium, whose initial magnetic resonance imaging revealed at least one PI-RADS 5 lesion and who subsequently underwent AS. The primary endpoint was BCR-free survival. The secondary endpoints included metastasis-free survival, time to biopsy grade reclassification, and time to AS discontinuation, along with their predictors.
After a median follow-up of 36 mo after confirmatory biopsies (95% confidence interval [CI] 23-55), BCR was observed in five patients, with the median time not reached. The 5-yr BCR-free survival rate was 88% (95% CI 79-99%). No metastatic progression was reported. Seventeen patients experienced biopsy grade reclassification (median time not reached), and 55 patients discontinued AS. The median time to AS discontinuation was 55 mo (95% CI 46 mo-not applicable). The 5-yr AS discontinuation-free survival rate was 41% (95% CI 30.8-54.6%). On a multivariate Cox regression analysis, baseline prostate-specific antigen density and the percentage of positive biopsy cores were associated with biopsy grade reclassification, AS discontinuation, and BCR.
With strict monitoring, AS is a safe management option for patients with PI-RADS 5 lesions and favorable-risk PCa. Limitations are mainly inherent to the retrospective design of this study.
European urology oncology. 2025 Feb 17 [Epub ahead of print]
Arthur Peyrottes, Michael Baboudjian, Romain Diamand, Quentin Ducrot, Cyril Vitard, Arthur Baudewyns, Olivier Windisch, Julien Anract, Charles Dariane, Thibault Tricard, Julien Sarkis, Yvanne Sadreux, Marco Oderda, Thibaut Long Depaquit, Alexandre De La Taille, Jonathan Olivier, Laurent Brureau, Olivier Rouviere, Sébastien Crouzet, Alain Ruffion, François Desgrandchamps, Matthieu Roumiguie, Morgan Rouprêt, Guillaume Ploussard, Gaelle Fiard, CCAFU Group
Department of Urology, Saint-Louis Hospital, Paris, France. Electronic address: ., Department of Urology, Hôpital Nord, Marseille, France., Department of Urology, Jules Bordet Institute, Hôpital Universitaire de Bruxelles, Brussels, Belgium., Department of Urology, Rangueil Hospital, Toulouse, France., Department of Urology, Lyon Sud Hospital, Pierre-Bénite, France., Division of Urology, Geneva University Hospitals, Geneva, Switzerland., Department of Urology, Cochin Hospital, Paris, France., Department of Urology, European Hospital Georges Pompidou, Paris, France., Department of Urology, Strasbourg University Hospital, Strasbourg, France., Department of Urology, Hotel-Dieu de France, Beirut, Lebanon., CHU de Pointe-à-Pitre, Univ Antilles, Univ Rennes, Inserm, EHESP, Irset (Institut de Recherche en Santé, Environnement et Travail) - UMR_S 1085, Pointe-à-Pitre, France., Urology Unit, Molinette Hospital, Turin, Italy., Department of Urology, Henri-Mondor Hospital, Paris, France., Department of Urology, Lille University Hospital, Lille, France., Department of Radiology, Edouard Herriot Hospital, Lyon, France., Department of Urology, Edouard Heriot Hospital, Lyon, France., Department of Urology, Saint-Louis Hospital, Paris, France., Department of Urology, La Pitié-Salpêtrière Hospital, Sorbonne University, Paris, France., Department of Urology, La Croix du Sud Hospital, Quint-Fonsegrives, France., Department of Urology, Univ. Grenoble Alpes, CNRS, CHU Grenoble Alpes, Grenoble INP, TIMC, Grenoble, France., Cancerology Committe of the French Urological Association (CCAFU), Maison de l'urologie, Paris, France.