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 8 Non-cytotoxic trials.

Trial	N randomized/evaluable	Treatments (dose) and schedule	Duration
Carducci, 2004 [85]	809/809	atrasentan po (10 mg)	NR
		placebo
Carducci, 2003 [79]	288/288	atrasentan (2.5 mg) po daily	to progression
		atrasentan (10 mg) po daily
		placebo
Small, 2003 [86]	127/127	APC8015 iv q 2 wks × 3	to progression
		placebo
Small, 2002 [81]	390/390	suramin (3.192 mg/m²)* iv	3 cycles (12 weeks)
		suramin (5.320 mg/m²)* iv
		suramin (7.661 mg/m²)* iv
Ahmann, 2001 [87]	553/406†	prinomastat (5 mg) po twice daily mitoxantrone (12 mg/m²) iv q 3 wks prednisone (5 mg) po twice daily	NR
		prinomastat (10 mg) po twice daily mitoxantrone (12 mg/m²) iv q 3 wks prednisone (5 mg) po twice daily
		mitoxantrone (12 mg/m²) iv q 3 wks prednisone (5 mg) po twice daily placebo
Small, 2000 [82]	460/458	suramin d1: 1000 mg/m² 2-hr iv d2-5: 400 mg/m², 300 mg/m², 250 mg/m², and 200 mg/m² iv, respectively d8,11,15,19: 275 mg/m² iv for 2 wks d22,29,36,43,50,57,64,71,78: 275 mg/m² iv wks 4–12 hydrocortisone (40 mg) po daily	to progression or unacceptable toxicity
		hydrocortisone po daily placebo
Debruyne, 1998 [83]	321/321	liarozole (300 mg) twice daily	to progression or unacceptable toxicity
		CPA (100 mg) twice daily

*Doses of suramin decreased over 10 weeks; all patients received hydrocortisone at a dose of 25 mg orally each morning and 15 mg orally each evening; †interim results available for 406/553 patients.
Abbreviations: CPA – cyproterone acetate; d – day; DES – diethylstilbestrol diphosphate; g – grams; hr – hour; iv – intravenous; m² - meters squared; mg – milligram; N – number; NR – not reported; po – per oral; q – every; wk(s) – week(s); × – times.

ISSN: 1471-2407