Editing Castrate-Resistant Prostate Cancer (section)

====== Enzalutamide ======
* '''See Hormonal Therapy Chapter Notes'''
* '''Indications'''
** '''mCRPC, pre- or post-docetaxel'''
* '''AFFIRM (2012)'''
** Population: 1,199 men with mCRPC who had failed docetaxel, ketoconazole naïve
** Randomized to enzalutamide (160mg/day) vs. placebo
** Primary outcome: OS
** Results:
*** Significantly improved OS by 5 months with enzalutamide (18.4 enzalutamide vs. 13.6 months placebo)
*** All secondary endpoints were also significantly improved with enzalutamide: percentage of patients with 50% PSA reduction, soft-tissue response rate, QOL response rate, time to PSA progression, radiographic PFS (5.3 months) and time to first SRE.
** Scher, Howard I., et al."Increased survival with enzalutamide in prostate cancer after chemotherapy." ''New England Journal of Medicine'' 367.13 (2012): 1187-1197.
** FDA-approved in 2012 for treatment of mCRPC in patients who have previously received docetaxel-containing chemotherapy
* To evaluate the efficacy of enzalutamide in the prechemotherapy setting, the PREVAIL study was designed.
* '''PREVAIL (2014)'''
** Population: 1,717 chemotherapy-naïve patients with asymptomatic or minimally symptomatic mCRPC
** Randomized to oral enzalutamide (160mg/day) or placebo. Patients also had not received previous ketoconazole or abiraterone.
** Results:
*** Significantly improved OS (HR 0.71) and radiographic PFS (HR 0.19) with enzalutamide
** Beer, Tomasz M., et al."Enzalutamide in metastatic prostate cancer before chemotherapy." New England Journal of Medicine 371.5 (2014): 424-433.
** FDA-approved in 2015 for treatment of mCRPC in docetaxel-naive patients