Table 1.

Baseline demographics and clinical characteristics

Ipatasertib 400 mg + abirateroneIpatasertib 200 mg + abirateronePlacebo + abiraterone
Characteristics(n = 84)(n = 86)(n = 83)
Stratification factors (%)
 Prior enzalutamide7 (8)9 (10)7 (8)
 Progression factor at trial entry, n (%)
  PSA + radiographic42 (50)42 (49)47 (57)
  PSA only36 (43)32 (37)30 (36)
  Radiographic only6 (7)12 (14)6 (7)
 Number of prior chemotherapy regimens for metastatic disease
  169 (82)69 (80)62 (75)
  >115 (18)17 (20)21 (25)
Other factors
 Age, mean (SD), y66.9 (8.5)68.8 (7.2)67.6 (7.8)
 Stage IV at diagnosis, n (%)52 (68)40 (51)45 (56)
ECOG PS at enrollment, n (%)
 043 (51)38 (44)32 (39)
 141 (49)47 (55)51 (61)
Gleason score, n (%)
 ≤731 (37)30 (35)34 (41)
 ≥848 (57)52 (61)46 (55)
Sites of metastatic disease, n (%)
 Liver9 (11)9 (10)8 (10)
 Lung11 (13)16 (19)8 (10)
 Bone77 (93)80 (93)78 (94)
 Lymph node42 (51)43 (50)40 (48)
PSA, mean (SD), μg/L379 (1012)261 (623)230 (329)
Alkaline phosphatase, IU/mL198 (220)217 (301)251 (326)
  • Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; y, years.