Apalutamide and Stereotactic Body Radiotherapy in Metastatic Hormone-Sensitive Prostate Cancer: Multicenter Real-World Study

Background: The management of metastatic hormone-sensitive prostate cancer (mHSPC) has evolved with the integration of androgen receptor signaling inhibitors (ARSIs) and metastasis-directed therapies (MDTs). Stereotactic body radiotherapy (SBRT) offers precise local control, yet real-world data on i...

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Detalhes bibliográficos
Autores: Encarnación, JA, Macías, VM, Muñoz, ID, Soria, VD, Fornos, LF, Antequera, MA, Rey, OA, Martínez, VG, Alonso-Romero, JL, Gómez, RG
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Recursos:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositorio:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:fisabio.fundanetsuite.com:p19187
Acesso em linha:https://fisabio.portalinvestigacion.com/publicaciones/19187
Access Level:acceso abierto
Palavra-chave:metastatic prostate cancer
apalutamide
stereotactic body radiotherapy
SBRT
androgen receptor signaling inhibitors
real-world study
PSA response
metastasis-directed therapy
oligometastatic disease
Descrição
Resumo:Background: The management of metastatic hormone-sensitive prostate cancer (mHSPC) has evolved with the integration of androgen receptor signaling inhibitors (ARSIs) and metastasis-directed therapies (MDTs). Stereotactic body radiotherapy (SBRT) offers precise local control, yet real-world data on its combination with apalutamide remain limited. Methods: We conducted a multicenter retrospective cohort study including 134 patients with mHSPC treated with apalutamide and SBRT between February 2021 and December 2024. The primary endpoints were progression-free survival (PFS), local control (LC), and treatment safety. PSA kinetics and radiologic response were evaluated, and outcomes were analyzed according to PSA thresholds and treatment timing. Results: Most patients (93.3%) had low-volume disease; 97.1% presented with <= 5 metastases. At a median follow-up of 28 months, LC was 99.3% and 95.5% of patients were progression-free. Complete radiological response was achieved in 87.5% of patients, and 68.4% attained ultralow PSA levels (<= 0.02 ng/mL). Undetectable PSA and radiologic complete response were independently associated with improved PFS (p = 0.010 and p = 0.011, respectively). Treatment was well tolerated, with grade >= 3 toxicity occurring in only 2.2% of patients. Conclusions: The combination of apalutamide and SBRT in mHSPC is associated with high local and systemic disease control and minimal toxicity in a real-world setting. This approach may delay systemic treatment intensification and the onset of castration resistance. Prospective studies are warranted to confirm these findings.