Table 1.

Baseline patient demographics and disease characteristics

CharacteristicN = 39a
Median age (range), y71 (53–81)
Race, n (%)
 White35 (90)
 Black or African American4 (10)
ECOG performance status, n (%)
 033 (85)
 16 (15)
Gleason score >7, n (%)20 (51)
Median (range)
 PSA12.1 ng/mL (2.6–67.8)
 Testosterone (n = 38)8.5 ng/dL (1.4–17.3)
 ACTH (n = 32)19.5 ng/L (0–47)
 PSADT2.4 months (0.9–9.2)
Prior surgery, n (%)
 Radical prostatectomy25 (67)
 Bilateral orchiectomy2 (5)

NOTE: Two patients received prior ketoconazole (protocol deviations).

  • aN = 39 represents all 39 treated patients.