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Multicenter Study
. 2025 Apr;8(2):444-451.
doi: 10.1016/j.euo.2024.11.005. Epub 2024 Nov 29.

Apalutamide in Metastatic Castration-sensitive Prostate Cancer: Results from the Multicenter Real-world ARON-3 Study

Matteo Santoni  1 , Thomas Büttner  2 , Pasquale Rescigno  3 , Ondrej Fiala  4 , Nicolò Cavasin  5 , Umberto Basso  5 , Tarek Taha  6 , Francesco Massari  7 , Zin W Myint  8 , Luigi Formisano  9 , Luca Galli  10 , Sarah Scagliarini  11 , Marc R Matrana  12 , Gaetano Facchini  13 , Aristotelis Bamias  14 , Carlo Messina  15 , Francesca Zacchi  16 , Ray Kopp Manneh  17 , Giandomenico Roviello  18 , Daniele Santini  19 , Alexandr Poprach  20 , Jiri Navratil  20 , Michal Uher  20 , Fabio Calabrò  21 , Erin Pierce  11 , Rossana Berardi  22 , Gaetano Aurilio  23 , Roubini Zakopoulou  13 , Alessandro Rizzo  24 , Jawaher Ansari  25 , Mimma Rizzo  26 , Renato Bisonni  27 , Veronica Mollica  28 , Lorena Incorvaia  29 , Gianpaolo Spinelli  30 , Xue Yan Jiang  31 , Robert Adam Chandler  31 , Francesco Grillone  32 , Franco Morelli  33 , Sebastiano Buti  34 , Fernando C Maluf  35 , Fernando Sabino Marques Monteiro  36 , Nicola Battelli  1 , Camillo Porta  37 , Orazio Caffo  38 , Andrey Soares  39
Affiliations
Multicenter Study

Apalutamide in Metastatic Castration-sensitive Prostate Cancer: Results from the Multicenter Real-world ARON-3 Study

Matteo Santoni et al. Eur Urol Oncol. 2025 Apr.

Abstract

Background and objective: Apalutamide (APA) is a treatment for metastatic castration-sensitive prostate cancer (mCSPC). In the ARON-3 study we investigated real-world experiences with APA treatment for mCSPC.

Methods: We retrospectively assessed real-world clinical outcomes for patients with mCSPC treated with APA in the ARON-3 study. Overall survival (OS) was calculated from APA initiation to death from any cause. PSA90 was defined as a prostate-specific antigen decline of ≥90% from baseline, and PSA0.2 as achievement of a PSA level ≤0.2 ng/ml. Data for adverse events were retrospectively collected from electronic and paper charts and categorized according to Common Terminology Criteria for Adverse Events v5.0.

Key findings and limitations: We included 531 patients with mCSPC treated with APA. High-volume disease was reported for 214 patients (40%), and 56 (11%) had visceral metastases. Median OS was not reached. PSA90 was experienced by 461 patients (87%) and PSA0.2 by 368 (69%). Median OS was significantly longer for patients with PSA90 or PSA0.2 than for subjects without these responses (p < 0.001). The incidence of grade 3-4 fatigue was higher among elderly patients (≥80 yr) than among younger patients (19% vs 5%), but the incidence of other adverse events was comparable between the age groups.

Conclusions and clinical implications: APA is an effective and tolerable treatment for mCSPC in the real-world setting.

Patient summary: The ARON-3 project collects data for patients with prostate cancer treated in multiple centers worldwide to assess outcomes in the real-world setting. We analyzed data for patients with metastatic hormone-sensitive prostate cancer receiving apalutamide. Our results show that apalutamide is a safe and effective drug in the real-world setting as well as in clinical trials.

Keywords: ARON-3 trial; Androgen receptor pathway inhibitor; Apalutamide; Castration-sensitive prostate cancer; Hormone sensitive; Prostate cancer.

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