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====== <span style="color:#ff00ff">PROSPER ====== * 1401 men with non-metastatic CRPC, PSA doubling time β€10 months and PSA β₯2ng/mL * Randomized to enzalutamide or placebo * Primary outcome: metastasis-free survival * Results: ** Median follow-up: 48 months (2020 update) ** Metastasis-free survival significantly improved by 22 months in the enzalutamide arm (37 enzalutamide vs. 15 months placebo (HR for metastasis or death, 0.28)) ** Overall survival *** Original 2018 publication: median OS was not reached in either group; however, there was a 20% reduction in the relative risk of death with enzalutamide compared to placebo. *** Updated 2020 publication: significantly improved by 11 months (67 enzalutamide vs. 56 placebo, HR 0.73) ** Additionally, median time to PSA progression was approximately 33 months longer in patients receiving enzalutamide compared to those receiving placebo with a 93% reduction in the relative risk of PSA progression (37.2 months in the enzalutamide group compared to 3.9 months in the placebo group; HR= 0.07; P<0.001). ** Adverse events as the primary reason for treatment discontinuation occurred in 87 patients (9%) receiving enzalutamide compared to 28 (6%) receiving placebo. Deaths due to adverse events on trial irrespective of attribution occurred in 32 patients (3%) receiving enzalutamide and 3 patients (1%) receiving placebo. Adverse events noted to occur more frequently with enzalutamide included convulsion, hypertension, neutropenia, memory impairment disorders, and major cardiovascular events * [https://www.ncbi.nlm.nih.gov/pubmed/29949494 Hussain, Maha, et al."Enzalutamide in men with nonmetastatic, castration-resistant prostate cancer." New England Journal of Medicine 378.26 (2018): 2465-2474.] * [https://pubmed.ncbi.nlm.nih.gov/32469184/ Sternberg, Cora N., et al. "Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer." ''New England Journal of Medicine'' (2020).]
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