Treatment recommendations for patients with limited nodal recurrences are lacking, and different locoregional treatment approaches are currently being used.
The aim of this trial is to compare metastasis-directed therapy (MDT) with or without elective nodal pelvic radiotherapy (ENRT).
PEACE V-Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM) is an international, phase 2, open-label, randomized, superiority trial (ClinicalTrials.gov identifier: NCT03569241). Patients diagnosed with positron emission tomography-detected pelvic nodal oligorecurrence (five or fewer nodes) following radical local treatment for prostate cancer were randomized in a 1:1 ratio between arm A (MDT and 6 mo of androgen deprivation therapy [ADT]) and arm B (ENRT [25 × 1.8 Gy] with MDT and 6 mo of ADT).
We report the secondary endpoint acute toxicity, defined as worst grade ≥2 Common Terminology Criteria for Adverse Events v4.0 gastrointestinal (GI) or genitourinary (GU) toxicity within 3 mo of treatment. The chi-square test was used to compare toxicity between treatment arms. We also compare the quality of life (QoL) using the European Organisation for Research and Treatment of Cancer QLQ C30 and PR25 questionnaires.
Between June 2018 and April 2021, 196 patients were assigned randomly to MDT or ENRT. Ninety-seven of 99 patients allocated to MDT and 93 of 97 allocated to ENRT received per-protocol treatment. Worst acute GI toxicity proportions were as follows: grade ≥2 events in three (3%) in the MDT group versus four (4%) in the ENRT group (p = 0.11). Worst acute GU toxicity proportions were as follows: grade ≥2 events in eight (8%) in the MDT group versus 12 (13%) in the ENRT group (p = 0.95). We observed no significant difference between the study groups in the proportion of patients with a clinically significant QoL reduction from baseline for any subdomain score area.
No clinically meaningful differences were observed in worst grade ≥2 acute GI or GU toxicity or in QoL subdomains between MDT and ENRT.
We found no evidence of differential acute bowel or urinary side effects using metastasis-directed therapy and elective nodal radiotherapy for the treatment of patients with a pelvic lymph node recurrence.
European urology oncology. 2023 Oct 09 [Epub ahead of print]
Piet Ost, Shankar Siva, Sigmund Brabrand, Piet Dirix, Nick Liefhooghe, François-Xavier Otte, Alfonso Gomez-Iturriaga, Wouter Everaerts, Mohamed Shelan, Antonio Conde-Moreno, Fernando López Campos, Alexandros Papachristofilou, Matthias Guckenberger, Marta Scorsetti, Almudena Zapatero, Ana-Elena Villafranca Iturre, Clara Eito, Felipe Couñago, Paolo Muto, Lien Van De Voorde, Nicolas Mach, Renée Bultijnck, Valérie Fonteyne, Daniel Moon, Kristian Thon, Carole Mercier, Vérane Achard, Karin Stellamans, Els Goetghebeur, Dries Reynders, Thomas Zilli
Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Iridium Netwerk, GZA Ziekenhuizen, Antwerp, Belgium. Electronic address: ., EJ Whitten Prostate Cancer Centre, Melbourne, Australia; ICON Cancer Centre, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia., Oslo University Hospital, Oslo, Norway., Iridium Netwerk, GZA Ziekenhuizen, Antwerp, Belgium., AZ Groeninge, Kortrijk, Belgium., Jules Bordet Institute, Brussels, Belgium., Hospital Universitario Cruces, Biocruces Bizkaia Health Research Institute, Barakaldo, Spain., LICR, Department of Cellular and Molecular Medicine, KU Leuven & University Hospitals Leuven, Leuven, Belgium., Inselspital University Cancer Center, Bern, Switzerland., Hospital Universitari i Politècnic la Fe, Valencia, Spain., Hospital Universitario Ramón y Cajal, Madrid, Spain., Universitätsspital Basel, Basel, Switzerland., University Hospital Zurich, University of Zurich, Zurich, Switzerland., Radiotherapy and Radiosurgery Department, Humanitas Clinical and Research Hospital, IRCSS, Rozzano, Italy., University Hospital La Princesa, Madrid, Spain., Complejo Hospitalario de Navarra, Navarra, Spain., Instituto Oncólogico Clinica Universitaria IMQ, Bilbao, Spain., University Hospital Quironsalud, Madrid, Spain; Universidad Europea de Madrid, Madrid, Spain., Napoli Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy., AZ St-Lucas Ghent, Ghent, Belgium., Geneva University Hospital, Geneva, Switzerland; Faculty of Medicine, University of Geneva, Geneva, Switzerland., Department of Human Structure and Repair, Ghent University, Ghent, Belgium., Royal Melbourne Clinical School, University of Melbourne, Melbourne, Australia., Department of Applied Mathematics, Computer Science and Statistics, Ghent University, Ghent, Belgium., Geneva University Hospital, Geneva, Switzerland; Faculty of Medicine, University of Geneva, Geneva, Switzerland; Oncology Institute of Southern Switzerland, EOC, Bellinzona, Switzerland; Università della Svizzera Italiana, Lugano, Switzerland. Electronic address: .