Non-hormonal systemic therapy in men with hormone-refractory prostate cancer and metastases: a systematic review from the Cancer Care Ontario Program in Evidence-based Care's Genitourinary Cancer Disease Site Group

Table 10 Non-cytotoxic trials: PSA and tumor response.

Trial	Treatment arms	PSA response*			Tumor response
		N	Response rate %, unless otherwise specified	Statistical comparison	N	Objective response rate %	Statistical comparison
Carducci, 2004 [85]	Atrasentan	408	"smaller mean ↑ with atrasentan vs. placebo"	p = 0.025	NR
	placebo	401
Carducci, 2003 [79]	atrasentan 10 mg	median time-to-PSA progression:			NR
		89	5.5 mo	p = 0.002
	atrasentan 2.5 mg	95	5 mo	p = 0.055
	placebo	104	2.5 mo	NA
Small, 2003 [86]	APC8015	82	4.9	NR	NR
	placebo	45	0
Small, 2002 [81]	suramin (3.192 g/m²)	128	24	p = 0.08 (test for trend)	128	9	p = 0.104 (test for trend)
	suramin (5.320 g/m²)	124	28		124	7
	suramin (7.661 g/m²)	120	34		120	15
Ahmann, 2001 [87]	prinomastat (5 mg) mitoxantrone prednisone	134	17†	p = NS	NR
	prinomastat (10 mg) mitoxantrone prednisone	134	18†
	mitoxantrone prednisone placebo	138	14†
Small, 2000 [82]	suramin hydrocortisone	228	33	p = 0.01	76	4 (PR)	NR
	placebo hydrocortisone	230	16		80	0
Debruyne, 1998 [83]	liarozole	160	20	p < 0.001	NR
	CPA	161	4

*PSA response was defined as = 50% decrease in PSA compared with baseline; †75% reduction in PSA for 3 weeks.
Abbreviations: CPA – cyproterone acetate; DES – diethylstilbestrol; g – grams; mg – milligrams; mo – months; N – number; NA – not applicable; NR – not reported; NS – non-significant; PR – partial response; PSA – prostate-specific-antigen; vs. – versus.

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