S1128
Clinical - Urology
ESTRO 2026
placebo. Two RT regimens were allowed: (1) a conventional scheme delivering 76–78 Gy in 38–39 fractions to the prostate, 70 Gy to involved nodes, and 46–50 Gy to elective pelvic nodes; or (2) a hypofractionated scheme delivering 60 Gy in 20 fractions (3 Gy/fraction) to the prostate, 56 Gy (2.8 Gy/fraction) to involved nodes, and 44 Gy (2.2 Gy/fraction) to elective nodes. All patients received daily image guidance and 24 months of ADT. Adverse events (AEs) were graded using CTCAE v5.0. Results: Among 83 patients, 652 Treatment Emergent Adverse Events (TEAEs) were reported. Most were Grade 1 (66.9%) or Grade 2 (26.2%); 38 (5.8%) were Grade ≥ 3. A total of 27 serious adverse events (SAEs) were observed. The most frequent SAEs were urinary retention (n=4) and anemia (n=2). Others included cardiac failure, septic shock, prostatitis, osteoarthritis, maculopapular rash and trauma-related events. SAE severity was most commonly Grade 3 (n=17), followed by Grade 2 (n=5), Grade 4 (n=4), Grade 1 (n=1) and Grade 5 (n=0). The most affected organ systems were the renal/urinary tract (n=8), cardiovascular system (n=5), and hematologic system (n=3). In total, 96.3% of SAEs were deemed unrelated to study treatment; only one was judged definitely related (maculopapular rash). No unexpected toxicity signals were observed. Conclusion: Safety data from the ALADDIN trial confirm that the addition of Darolutamide to ADT and RT is feasible and generally well tolerated in patients with node-positive prostate cancer. The SAE profile was consistent with known toxicities in this population. These results support further investigation of treatment intensification in high-risk localized prostate cancer. Keywords: Prostate cancer, Node positive, Darolutamide Prognostic Value of Early PSA Kinetics and ISUP Grading in Locally Advanced Prostate Cancer Treated with Hypofractionated Radiotherapy and ADT Meral KURT 1 , Mehmet Cagatay Cicek 2 , Asma Daneshvar 1 , Gurkan Aslan 1 , Nino Kakhadze 1 1 Radiation Oncology, Uludag University, Bursa, Turkey. 2 Urology, Uludag University, Bursa, Turkey Purpose/Objective: Hypofractionated radiotherapy (HFRT) has emerged as an effective alternative to conventional fractionation for prostate cancer. However, evidence demonstrating its effectiveness in high risk disease is limited. This study aimed to evaluate the oncological outcomes and prognostic significance of early PSA kinetics with Digital Poster 110
Mini-Oral 51 Safety Profile of Darolutamide Combined With ADT and Radiotherapy in Node-Positive Prostate Cancer: Analysis From the GETUG-P17 ALADDIN Trial Jean-Emmanuel Bibault 1 , Stéphane Supiot 2 , Ali Hasbini 3 , Pierre Combe 4 , Thomas Leroy 5 , Nathalie Mesgouez-Nebout 6 , Ulrike Schick 7 , David Pasquier 8 , Amandine Ruffier 9 , Carole Iriart 10 , Adrien Laville 11 , Jonathan Khalifa 12 , Carole Helissey 13 , Ingrid Fumagalli 14 , Pierre Graff 15 , François-Georges Riet 16 , Lysian Cartier 17 , Etienne Martin 18 , Paul Sargos 19 , Houda Belhouari 20 , Eve Lepicard 20 , Stéphane Oudard 21 1 Radiation Oncology Department, Hôpital Européen Georges Pompidou, Paris, France. 2 Radiation Oncology Department, ICO, Nantes, France. 3 Radiation Oncology Department, Centre Finistérien, Brest, France. 4 Medical Oncology Department, CORT37, Tours, France. 5 Radiation Oncology Department, Les Dentellières, Valenciennes, France. 6 Radiation Oncology Department, ICO, Angers, France. 7 Radiation Oncology Department, CHU Brest, Brest, France. 8 Radiation Oncology Department, Centre Oscar Lambret, Lille, France. 9 Radiation Oncology Department, ILC, Le Mans, France. 10 Radiation Oncology Department, CHU Grenoble, Grenoble, France. 11 Radiation Oncology Department, CHU Amiens, Amiens, France. 12 Radiation Oncology Department, IUCT Oncolpole, Toulouse, France. 13 Medical Oncology Department, Hopital d'Instruction des Armées BEGIN, Saint Mandé, France. 14 Radiation Oncology Department, Hôpital des Peupliers, Paris, France. 15 Radiation Oncology Department, Institut Curie, Paris, France. 16 Radiation Oncology Department, Institut de Cancérologie et Radiothérapie Bretillien, Rennes, France. 17 Radiation Oncology Department, Institut Sainte Catherine, Avignon, France. 18 Radiation Oncology Department, Centre Georges-François Leclerc, Dijon, France. 19 Radiation Oncology Department, Institut Bergonié, Bordeaux, France. 20 Clinical Research Department, ARTIC, Paris, France. 21 Medical Oncology Department, Hôpital Européen Georges Pompidou, Paris, France Purpose/Objective: The standard of care for newly diagnosed pelvic node- positive prostate cancer includes long-term androgen deprivation therapy (ADT) and Intensity-Modulated Radiotherapy (IMRT). In this phase 3 multicenter trial (ALADDIN, NCT05116475), we hypothesize that adding Darolutamide to ADT and RT improves failure-free survival (FFS) compared to ADT and RT alone. We report the safety outcomes of this association. Material/Methods: Patients with hormone-sensitive prostate cancer and pelvic lymph node metastases were randomized 1:1 to receive ADT plus IMRT with either Darolutamide or
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