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

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 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     
  1. *PSA response was defined as = 50% decrease in PSA compared with baseline; †75% reduction in PSA for 3 weeks.
  2. 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.