TABLE I.

Baseline Patient Characteristics

Parameter	Value
Age (years) at initiation of ketoconazole: mean ± SD (range); median	68.14 ± 8.83 (50–88); 69
Combined Gleason grade
Low risk (≤6)	7% (n = 8)
Intermediate risk [7]	40% (n = 46)
High risk [8–10]	49% (n = 56)
Unknown	4% (n = 4)
Primary treatment
Radical prostatectomy	58% (n = 66)
Radiation therapy	19% (n = 22)
Primary androgen deprivation therapy	20% (n = 23)
Unknown	3% (n = 3)
Response to antiandrogen (months) as second line androgen deprivation for metastatic disease: mean ± SD (range); median	7.7 ± 7.38 (1–36); 5
Baseline PSA doubling time (months) before the initiation of ketoconazole: mean ± SD (range); median	4 ± 4.63 (0.4–29.3); 2.67
Baseline PSA level (ng/ml) before the initiation of ketoconazole: mean ± SD (range); median	167.58 ± 539.86 (0.4–4418); 14.83
Disease extent
Limited (axial skeleton and/or lymph nodes)	33% (n = 38)
Extensive (appendicular skeleton and/or visceral organs)	67% (n = 76)
ECOG performance status
0–1	94% (n = 108)
2	4% (n = 4)
Unknown	2% (n = 2)
Alkaline phosphatase (units/L)	134.2 ± 132 (31–825), 89
Hemoglobin (g/dl): mean ± SD (range); median	13 ± 1.5 (8–15.4), 13.2