Resumen.-En la actualidad el cáncer de próstata es la neoplasia no cutánea más frecuente entre los hombres en USA, ocupando en nuestro país la segunda posición tras el cáncer de pulmón. En los últimos años se ha modificado el perfil del cáncer de próstata diagnosticado debido a la amplia difusión de la determinación del PSA. En la actualidad aproximadamente el 47% de los cánceres de próstata que se diagnostican son de bajo riesgo. En esta situación terapias mínimamente invasivas como la braquiterapia cada vez tienen una mayor aceptación en nuestro medio.
Radical retropubic prostatectomy is an excellent treatment form for patients with clinically localized prostate cancer. A strict selection of patients candidates is important to obtain good results.
Aim: Darolutamide significantly prolonged metastasis-free survival (MFS) versus placebo in the Phase III ARAMIS study. We analyzed outcomes in Spanish participants in ARAMIS. Patients & methods: Patients with high-risk nonmetastatic castration-resistant prostate cancer were randomized 2:1 to darolutamide 600 mg twice daily or placebo, plus androgen-deprivation therapy. The primary end point was MFS. Descriptive statistics are reported for this post hoc analysis. Results: In Spanish participants, darolutamide (n = 75) prolonged MFS versus placebo (n = 42): hazard ratio 0.345, 95% confidence interval 0.175–0.681. The incidence and type of treatment-emergent adverse events were comparable between treatment arms. Conclusion: For Spanish participants in ARAMIS, efficacy outcomes favored darolutamide versus placebo, with a similar safety profile, consistent with the overall ARAMIS population. Clinical Trials Registration: NCT02200614 ( ClinicalTrials.gov )
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