Table 1.

Phase III clinical trials of FDA-approved drugs for metastatic castration-resistant prostate cancer

Study	Year	Indication	N	PSA50 declinea	SRE benefit	Quality of life	mPFS (months)	Overall survival
								Median (months)	HR	P-value
Docetaxel vs mitoxantroneb,23	2004	1st line chemo	1,006	45% vs 32%	NA	Yes	NS	18.9 vs 16.5	0.76	0.009
Cabazitaxel vs mitoxantroneb,22	2010	Post-docetaxel	755	39% vs 18%	NA	NA	2.8 vs 1.4	15.1 vs 12.7	0.70	<0.001
Sipuleucel-T vs placebo26	2010	Pre- and post-docetaxel	512	2.6% vs 1.3%	NA	NA	3.7 vs 3.6	25.8 vs 21.7	0.78	0.03
Abiraterone vs placebo8,24	2011	Post-docetaxel	1,195	29% vs 6%	Yes	Yes	5.6 vs 3.6	14.8 vs 10.9	0.65	<0.001
Abiraterone vs placebo9,25	2012	Pre-docetaxel	1,088	62% vs 24%	NA	Yes	16.5 vs 8.3	34.7 vs 30.3	0.81	0.0033
Enzalutamide vs placebo10	2012	Post-docetaxel	1,199	54% vs 2%	Yes	Yes	8.3 vs 2.9c	18.4 vs 13.6	0.63	<0.001
Radium-223 vs placebod,27	2013	Pre- and post-docetaxele	921	16% vs 6%f	Yes	Yes	3.6 vs 3.4g	14.9 vs 11.3	0.70	<0.001
Enzalutamide vs placebo11	2014	Pre-docetaxel	1,717	78% vs 3%	Yes	Yes	NR vs 3.9c	NR vs 31.0	0.73	<0.001

Notes:

^aDefined as PSA reduction ≥50%;

^bprednisone was included in both experimental and control arms;

^cradiographic progression-free survival;

^dboth arms received best standard of care;

^epost-docetaxel or not candidates for docetaxel;

^fPSA reduction ≥30%;

^gtime to PSA progression.

Abbreviations: N, number of patients; SRE, skeletal related events; mPFS, median progression-free survival; chemo, chemotherapy; NS, non-significant; NA, not assessed; NR, not reached; PSA, prostate specific antigen; FDA, US Food and Drug Administration; HR, hazard ratio.