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== EMBARK Trial == * Population: 1068 patients with high-risk biochemical recurrence (defined as a PSA doubling time of β€9 months and a PSA level of β₯2 ng per milliliter above nadir after radiation therapy or β₯1 ng per milliliter after radical prostatectomy) * Randomized to enzalutamide + leuprolide vs. enzalutamide only vs. leuprolide only * Primary end point: metastasis-free survival in the combination group as compared with the leuprolide-alone group * Results: ** 5-year metastasis-free survival: absolute risk reduction: 16% (87% combination group vs. 71% leuprolide-alone group, significant); NNT: 6 ** 5-year overall survival: absolute risk reduction: 5% (92% combination group vs. 87% leuprolide-alone group, not significant) **Enzalutamide monotherapy better than leuprolide monotherapy for progression-free survival ***First evidence that second-generation androgen deprivation therapy monotherapy better than first-generation monotherapy * [https://pubmed.ncbi.nlm.nih.gov/37851874/ Freedland, Stephen J., et al.] "Improved outcomes with enzalutamide in biochemically recurrent prostate cancer." ''New England Journal of Medicine'' 389.16 (2023): 1453-1465.
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