Enzalutamide as a second generation antiandrogen for treatment of advanced prostate cancer

Figures & data

Figure 1 Molecular structure of enzalutamide.

Table 1 Summary of current clinical trials of enzalutamide against PCa

Study ID	Phase	Individuals enrolled (n)	Condition	Status	Primary completion date
NCT01091103	II	60	Metastatic CRPC	Active, not recruiting	September, 2011
NCT00974311	III	1,199	CRPC	Active, not recruiting	November, 2011
NCT01284920	I–II	46	Prostate neoplasm/PCa/CRPC	Recruiting	December, 2012
NCT01302041	II	60	PCa	Active, not recruiting	July, 2012
NCT00510718	I	100	PCa/CRPC	Active, not recruiting	July, 2012
NCT01547299	II	50	PCa	Recruiting	June, 2013
NCT01650194	II	60	Metastatic CRPC	Recruiting	June, 2013
NCT01664923	II	400	PCa	Recruiting	July, 2013
NCT01288911	II	370	Prostate neoplasm	Recruiting	July, 2013
NCT01565928	I	18	PCa	Active, not recruiting	March, 2014
NCT01212991	III	1,680	PCa	Recruiting	September, 2014
NCT01663415	II	0	Metastatic CRPC	Withdrawn	October, 2014
NCT01534052	II	14	CRPC	Enrolling by invitation	December, 2022

Abbreviations: CRPC, castration-resistant prostate cancer; PCa, prostate cancer.

Figure 2 Kaplan–Meier estimates of primary and secondary outcome measures in Phase I–II clinical trial of enzalutamide (ClinicalTrials.gov identifier: NCT00510718). (A) PSA progression defined as ≥25% increase in PSA from baseline. (B) PSA progression defined by Prostate Cancer Working Group criteria as ≥25% increase from nadir. (C) Progression-free survival defined by radiological imaging in chemotherapy-naïve and chemotherapy-treated patients. Reprinted from Scher HI, Beer TM, Higano CS, et al, Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1–2 study. Lancet. 375:1437–1446. Copyright 2010, with permission from Elsevier.⁴⁹

Abbreviation: PSA, prostate-specific antigen.

Figure 3 Kaplan–Meier estimates of primary and secondary outcome measures in Phase III clinical trial of enzalutamide (ClinicalTrials.gov identifier: NCT00974311). (A) Overall survival. (B) Progression-free survival defined by prostate-specific antigen progression. (C) Progression-free survival defined by radiological imaging. From N Engl J Med, Scher HI, Fizazi K, Saad F, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. 367;1187–1197. Copyright © 2012 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.⁵²

Abbreviations: CI, confidence interval; PSA, prostate-specific antigen.

Scher HI Beer TM Higano CS Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1–2 study Lancet 2010 375 9724 1437 1446 20398925

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Scher HI Fizazi K Saad F Increased survival with enzalutamide in prostate cancer after chemotherapy N Engl J Med 2012 367 13 1187 1197 22894553

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