Safety and Efficacy of First-Line Treatments for Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer: A Systematic Review and Indirect Comparison

Table 1

Characteristics of clinical trials included in this study.

Clinical trail	Design	Sources of patients	Follow-up (median, month)	Intervention	Control	Number of	Age (median, years	Gleason score (median)	PSA level (median, ng/ml)	ECOG PS (range)
D9902B NCT00065442	Phase 3	75 centers in the United States and Canada	34.1	Sipuleucel-T (3 complete doses/2 weeks)	APC placebo (3 complete doses/2 weeks)	341:171	72:70	NR	NR	0 to 1
D9901 NCT00005947	Phase 3	19 centers in the United States	36	Sipuleucel-T (3 complete doses/2 weeks)	APC placebo (3 complete doses/2 weeks)	82:45	73:71	7:7	46.0:47.9	0 to 1
D9902A NCT01133704	Phase 3	24 clinical trial sites	36	Sipuleucel-T (3 complete doses/2 weeks)	APC placebo (3 complete doses/2 weeks)	65:33	70:71	NR	61.3:44.0	0 to 1
PREVAIL NCT01212991	Phase 3	207 sites in 22 countries	31	Enzalutamide (160 mg/d)	Placebo	872:845	72:71	NR	54.1:44.2	0 to 1
COU-AA-302 NCT00887198	Phase 3	12 countries	49.2	Abiraterone (1000 mg/d) plus prednisone (10 mg/d)	Prednisone (10 mg/d)	546:542	71:70	NR	42:37.7	0 to 1
TAX 327 Tannock et al.	Phase 3	24 countries	20.8	Docetaxel (75 mg/m^2)/3 weeks plus prednisone (10 mg/d)	Mitoxantrone (12 mg/m^2)/3 weeks plus prednisone (10 mg/d)	335:337	68:68	NR	114:123	NR
Shen et al.	RCT	Single center	16.8	Docetaxel (75 mg/m^2)/3 weeks plus prednisone (10 mg/d)	Mitoxantrone (12 mg/m^2)/3 weeks plus prednisone (10 mg/d)	30:31	64:66	NR	63.45:100.86	NR
Zhou et al.; NCT00436839,	RCT	15 centers in China	60	Docetaxel (75 mg/m^2)/3 weeks plus prednisone (10 mg/d)	Mitoxantrone (12 mg/m^2)/3 weeks plus prednisone (10 mg/d)	113:115	70.7:70.8	8:8	70.9:100	NR
FIRSTANA NCT01308567	RCT	159 centers in 25 countries	51	Cabazitaxel (20 mg/m^2)/3 weeks plus prednisone (10 mg/d)	Docetaxel (75 mg/m^2)/3 weeks plus prednisone (10 mg/d)	389:391	NR	NR	NR	0 to 2
WILLIAM BERRY	Phase 3	Multicenter in the United States	21.8	Mitoxantrone (12 mg/m^2)/3 weeks plus prednisone (10 mg/d)	Prednisone (10 mg/d)	56:63	70:74	NR	56.7:71.0	0 to 2

PSA: prostate specific antigen; ECOG PS: Eastern Cooperative Oncology Group Performance Status; NR: not reported; RCT: randomized controlled trial. versus control.