EORTC 2238 "De-Escalate": a pragmatic trial to revisit intermittent androgen deprivation therapy in the era of new androgen receptor pathway inhibitors

Guillaume Grisay; Fabio Turco; Saskia Litiere; Béatrice Fournier; Anna Patrikidou; Enrique Gallardo; Ray McDermott; Ahu Alanya; Silke Gillessen; Bertrand Tombal

doi:10.3389/fonc.2024.1391825

EORTC 2238 "De-Escalate": a pragmatic trial to revisit intermittent androgen deprivation therapy in the era of new androgen receptor pathway inhibitors

Front Oncol. 2024 May 8:14:1391825. doi: 10.3389/fonc.2024.1391825. eCollection 2024.

Authors

Guillaume Grisay¹, Fabio Turco², Saskia Litiere³, Béatrice Fournier⁴, Anna Patrikidou⁵, Enrique Gallardo⁶, Ray McDermott⁷, Ahu Alanya⁸, Silke Gillessen^{2

9}, Bertrand Tombal¹⁰

Affiliations

¹ Department of Medical Oncology, Centres Hospitaliers Universitaires HELORA, La Louvière, Belgium.
² Oncology Institute of Southern Switzerland, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.
³ Statistics Department, European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium.
⁴ Medical Department, European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium.
⁵ Genito-Urinary Oncology Group and Early Drug Development (DITEP), Gustave Roussy, Villejuif, France.
⁶ Department of Oncology, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí (I3PT-CERCA), Universitat Autònoma de Barcelona, Sabadell, Spain.
⁷ Department of Medical Oncology, St Vincents University Hospital and Cancer Trials, Dublin, Ireland.
⁸ Quality of Life Department, European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium.
⁹ Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland.
¹⁰ Division of Urology, Cliniques Universitaires Saint Luc, Brussels, Belgium.

Abstract

The landscape of treating metastatic prostate cancer has evolved with the addition of Androgen Receptor pathway inhibitor (ARPI) to Androgen Deprivation Therapy (ADT), significantly improving survival rates. However, prolonged use of these therapies introduces notable side effects, prompting a need to revisit intermittent treatment duration. The EORTC 2238 De-Escalate trial is a pragmatic trial seeking to reassess the role of intermittent therapy in patients undergoing maximal androgen blockade (MAB) for metastatic hormone naïve prostate cancer (mHNPC), i.e., the combination of ADT with an ARPI, with the aims of reducing side effects, enhancing Quality of Life (QoL) and optimizing resource usage, while maintaining oncological benefits.

Keywords: AR pathway inhibitor; de-escalation; mHNPC; maximal androgen blockade; quality of life.

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This project has received funding from the European Union’s Horizon Europe under Grant Agreement number: 101104574. Views and opinions expressed are, however, those of the authors only and do not necessarily reflect those of the European Union. Neither the European Union nor the granting authority can be held responsible for them.