Table 1.

Completed or Ongoing Phase III Studies Examining Docetaxel-Based Combinations in the First-Line Treatment of Metastatic Castration-Resistant Prostate Cancer

Agent	Sample Size	Phase III Trial		Prior Phase II Trial(s)
		Primary End Point	Primary Result	Description, Including Primary End Point(s) Used	Was Primary End Point Met?
Antiangiogenic drugs
Docetaxel ± bevacizumab (NCT00110214)	1,050	OS	OS not improved in combination arm6; HR, 0.91; 95% CI, 0.78 to 1.05	Single-arm phase II study (n = 77) using PFS as primary end point	Primary end point not met7
Docetaxel ± aflibercept (NCT00519285)	1,224	OS	OS not improved in combination arm8; HR, 0.94; 95% CI, 0.82 to 1.08	No phase II combination studies conducted	—
Bone microenvironment agents
Docetaxel ± atrasentan (NCT00134056)	991	OS and PFS	OS not improved in combination arm9; HR, 1.01; 95% CI, 0.87 to 1.18	Single-arm phase II study (n = 23; expansion of phase I/II trial) using PSA response rate as primary end point	Primary end point not met10
Docetaxel ± zibotentan (NCT00617669)	1,052	OS	OS not improved in combination arm3; HR, 1.00; 95% CI, 0.84 to 1.18	Randomized phase II study (n = 31; expansion of phase I/II trial) using overall response rate and PSA response rate as primary end points	Primary end points not met4
Docetaxel ± dasatinib (NCT00744497)	1,380	OS	OS not improved in combination arm11; HR, 0.99; 95% CI, 0.87 to 1.13	Single-arm phase II study (n = 30; expansion of phase I/II trial) using PSA response rate as primary end point	Metric for success not defined12
Immune modulators
Docetaxel ± GVAX (NCT00133224)	408	OS	OS inferior in combination arm13; HR, 1.70; 95% CI, 1.15 to 2.53	No phase II combination studies conducted	—
Docetaxel ± lenalidomide (NCT00988208)	1,059	OS	OS inferior in combination arm14; HR, 1.53; 95% CI, 1.17 to 2.00	Single-arm phase II study (n = 20; expansion of phase I/II trial) using PSA response rate as primary end point	Metric for success not defined15
Miscellaneous agents
Docetaxel ± calcitriol (NCT00273338)	953	OS	OS inferior in combination arm16; HR, 1.42; 95% CI, 1.13 to 1.86	Randomized phase II study (n = 250) using PSA response rate as primary end point	Primary end point not met17
Docetaxel ± custirsen (NCT01188187)	800	OS	Study is ongoing	Randomized phase II study (n = 82) using PSA response rate as primary end point	Primary end point not met18

Abbreviations: HR, hazard ratio; OS, overall survival; PFS, progression-free survival; PSA, prostate-specific antigen