TABLE II.

Ketoconazole Treatment, PSA Response, and Disease Progression

Parameter	Value
Follow-up time (months): mean ± SD (range); median	40.1 ± 27.4 (5–129); 31
Ketoconazole dose
200 mg thrice daily dosage (tid)	32% (n = 36)
200 mg tid subsequently increased to 400 mg tid	40% (n = 46)
400 mg tid	28% (n = 32)
PSA response
PSA decrease (%) in the whole group: mean ± SD (range); median	29 ± 81.5% (−400 to 99.9); 53%
Patients with PSA decrease ≥50% in the whole group	54% (n = 61)
PSA decrease ≥50% in patients with limited vs. extensive disease	84% (n = 32/38) vs. 36% (n = 27/76), OR 9.1, P < 0.001
PSA decrease ≥50% in patients with pretreatment PSADT ≥3 vs. <3	62% (n = 31/50) vs. 44% (n = 28/64), OR 0.49, P = 0.01
Patients with PSA decrease <50%	21% (n = 24)
Patients refractory to treatment	25% (n = 29)
Time to progression (months): mean ± SD (range), median
Whole group	12.8 ± 17.1 (1–129), 8
In patients with limited vs. extensive disease	20.2 ± 23.4 (1–129), 14 vs. 9.1 ± 11.3 (1–74), 5
In patients with prior response to antiandrogen ≥6 vs. <6 months	18.8 ± 11 (3–129), 18.5 vs. 6.5 ± 11.9 (1–74), 4
In patients with pretreatment PSADT ≥3 vs. <3 months	17.9 ± 23 (1–129), 12 vs. 8.8 ± 9.4 (1–47), 5