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Dear Colleagues,The positive results of the phase III EMBARK trial (NCT02319837) 1 recently led to extended approval of the androgen receptor pathway inhibitor (ARPI) enzalutamide in prostate cancer (PCa).This study defined a new group of patients with high-risk, biochemically relapsed, non-metastatic (on conventional imaging) hormone-sensitive PCa according to the following inclusion criteria: prostate-specific antigen (PSA) ≥1 ng/mL after radical prostatectomy (RPE) as prior definitive curative treatment and >2 ng/mL after curative radiotherapy (RT), PSA doubling time (PSAdt) ≤9 months and testosterone ≥150 ng/dl.Patients (n=1068) were randomized 1:1:1 to receive androgen deprivation therapy (ADT), ADT plus enzalutamide or enzalutamide monotherapy.The primary endpoint was metastasis-free survival (MFS) with ADT versus ADT plus enzalutamide.The key secondary endpoint was MFS with ADT versus enzalutamide monotherapy and other secondary endpoints included overall survival (OS), safety, time to PSA progression and time to first new antineoplastic therapy.Treatment was suspended after 36 weeks in case of PSA <0.2 ng/mL and re-challenged if PSA was ≥5 ng/ml without prior RPE and ≥2 ng/ml with prior RPE.Patients who did not reach PSA <0.2 ng/ml at Week 36 continued the assigned treatment until progression to metastasis.The study was reported to be positive for its primary endpoint of MFS (ADT vs ADT plus enzalutamide) at the American Urology Association (AUA) meeting already in 2023 2 and consequently published in the New England Journal of Medicine. 1 In summary, the addition of enzalutamide to ADT was superior compared to ADT monotherapy (HR: 0.42 95% CI: 0.31-0.61) in prolonging MFS.The key secondary endpoint of interest was the comparison between enzalutamide monotherapy and ADT.Enzalutamide monotherapy also demonstrated statistically significant and clinically meaningful improvements in MFS (HR: 0.63 [95% CI: 0.46-0.87;p=0.0049), time to PSA progression and time to first new antineoplastic therapy.OS data are still pending; health-related quality of life (HRQoL) data were presented twice
A Fri, study studied this question.