Observation With or Without Subsequent Salvage Therapy for Pathologically Node-positive Prostate Cancer With Negative Conventional Imaging: Results From a Large Multicenter Cohort.

More than 10% of patients with negative clinical metastatic status (cN0M0) on conventional imaging for prostate cancer (PCa) harbor lymph node involvement (pN+) at final pathology following radical prostatectomy (RP) and lymphadenectomy. Our aim was to assess outcomes of initial observation for cN0M0 pN+ PCa and identify prognostic factors that may help in clinical decision-making.

We performed a retrospective multicenter study of patients with cN0M0 PCa on conventional imaging (computed tomography and/or magnetic resonance imaging, and a bone scan) who were found to have pN+ disease at RP between 2000 and 2021. Biochemical recurrence (BCR) and systemic progression/recurrence were the primary outcomes. Kaplan-Meier curves and Cox proportional hazards model were used for survival and multivariate analysis.

A total of 469 men were included in this retrospective multicenter trial. Median prostate-specific antigen (PSA) was 10.1 ng/ml (interquartile range [IQR] 6.6-18.0). Among these patients, 56% had grade group ≥4, 53.7% had stage ≥pT3b, 42.6% had positive margins, and 19.6% had PSA persistence. The median number of positive nodes and of nodes removed were 1 (IQR 1-3) and 20 (14-28), respectively. At median follow-up of 41 mo, 48.5% experienced BCR. The 5-yr BCR-free survival rate was 31.7% (95% confidence interval [CI] 26.33-37.1%). Salvage treatments were needed in 211 patients and included radiotherapy (RT; n = 53), RT + androgen deprivation therapy (ADT; n = 88), ADT alone (n = 68), and salvage lymphadenectomy (n = 2). The 5-yr estimated survival rates were 66.3% (95% CI 60.4-72.1) for metastasis-free survival, 97.7% (95% CI 95.5-99.8%) for cancer-specific survival, and 95.3% (95% CI 92.4-98.1%) for overall survival. On multivariable analysis, PSA persistence was an independent predictor of BCR (odds ratio [OR] 51.8, 95% CI 12.2-219.2), exit from observation (OR 8.5, 95% CI 4.4-16.5), and systemic progression (OR 3.0, 95% CI 1.771-4.971).

Initial observation in the management of pN+ cN0M0 PCa is feasible and has excellent survival rates in the intermediate term. Patients with worse disease features, especially PSA persistence, have a higher likelihood of recurrence and progression and may be candidates for more aggressive upfront management.

We investigated the value of initial observation for men with prostate cancer with negative scan findings for metastasis who were then found to have positive lymph nodes after surgery to remove the prostate. Our results show that initial observation is a good option for patients with less aggressive prostate cancer features.

European urology open science. 2024 Aug 22*** epublish ***

Giancarlo Marra, Federico Lesma, Gabriele Montefusco, Claudia Filippini, Jonathan Olivier, Andres Affentranger, Josias Bastian Grogg, Thomas Hermanns, Luca Afferi, Christian D Fankhauser, Agostino Mattei, Bartosz Malkiewicz, Simone Scuderi, Francesco Barletta, Sebastian Gallina, Alessandro Antonelli, Fabio Zattoni, Fabrizio Dal Moro, Wever Lieke, Timo Soeterik, Roderick C N van den Bergh, Pawel Rajwa, Shahrokh F Shariat, Lara Rodriguez-Sanchez, Rossella Nicoletti, Riccardo Campi, Mohamed Ahmed, R Jeffrey Karnes, Michael Ladurner, Isabel Heidegger, Alberto Briganti, Paolo Gontero, Giorgio Gandaglia, Young Academic Urologists Prostate Cancer Working Group

Division of Urology, Department of Surgical Sciences, University of Turin and Città della Salute e della Scienza, Turin, Italy., Department of Urology, Lille University Hospital, Lille, France., Department of Urology, University Hospital Zürich, Zurich, Switzerland., Department of Urology, Luzerner Kantonsspital, Lucerne, Switzerland., University Center of Excellence in Urology, Department of Minimally Invasive and Robotic Urology, Wroclaw Medical University, Wroclaw, Poland., Unit of Urology/Division of Oncology, IRCCS Ospedale San Raffaele, Milan, Italy., Department of Urology, University of Verona, Azienda Ospedaliera Universitaria Integrata, Verona, Italy., Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy., Department of Urology, St. Antonius Hospital, Utrecht, The Netherland., Department of Urology, Comprehensive Cancer Center, Vienna, Austria., Department of Urology, Institut Mutualiste Montsouris, Paris, France., Unit of Urological Robotic Surgery and Renal Transplantation, Careggi Hospital, University of Florence, Florence, Italy., Department of Urology, Mayo Clinic, Rochester, MN, USA., Department of Urology, Medical University Innsbruck, Innsbruck, Austria.