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Table 8 Non-cytotoxic trials.

From: 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

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  
  1. *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.
  2. 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.