PEACE V-Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM): Acute Toxicity of a Randomized Phase 2 Trial

Background: Treatment recommendations for patients with limited nodal recurrences are lacking, and different locoregional treatment approaches are currently being used. Objective: The aim of this trial is to compare metastasis -directed therapy (MDT) with or without elective nodal pelvic radiotherapy (ENRT). Design, setting, and participants: 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 x 1.8 Gy] with MDT and 6 mo of ADT). Outcome measurements and statistical analysis: 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. Results and limitations: 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. Conclusions: No clinically meaningful differences were observed in worst grade >= 2 acute GI or GU toxicity or in QoL subdomains between MDT and ENRT. Patient summary: 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. (c) 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.