Table 3 Study endpoints related to response

PSA response

  At week 12

2 (66.7, 9.4-99.2)

25 (64.1, 47.2-78.8)

51 (69.9, 58.0-80.1)

51 (67.1, 55.4-77.5)

2 (66.7, 9.4-99.2)

3 (100, 29.2-100)

134 (68.0, 61.0-74.5)

Maximum PSA decrease from baseline

  ≥50%

3 (100, 29.2-100)

28 (71.8, 55.1-85.0)

61 (83.6, 73.0-91.2)

57 (75.0, 63.7-84.2)

2 (66.7, 9.4-99.2)

3 (100, 29.2-100)

154 (78.2, 71.7-83.7)

  ≥90%

2 (66.7, 9.4-99.2)

16 (41.0, 25.6-57.9)

32 (43.8, 32.2-55.9)

32 (42.1, 30.9-54.0)

1 (33.3, 0.8-90.6)

3 (100, 29.2-100)

86 (43.7, 36.6-50.9)

Radiological response

Number of evaluable patients

1

11

19

26

3

1

61

  CR

0

1 (9.1)

0

2 (7.7)

0

0

3 (4.9)

  PR

0

2 (18.2)

6 (31.6)

8 (30.8)

1 (33.3)

1 (100.0)

18 (29.5)

  SD

1 (100.0)

4 (36.4)

13 (68.4)

12 (46.2)

2 (66.7)

0

32 (52.5)

  PD

0

3 (27.3)

0

3 (11.5)

0

0

6 (9.8)

  NE

0

1 (9.1)

0

1 (3.8)

0

0

2 (3.3)

  Objective response

0 (0, 0-97.5)

3 (27.3, 6.0-61.0)

6 (31.6, 12.6-56.6)

10 (38.5, 20.2-59.4)

1 (33.3, 0.8-90.6)

1 (100, 2.5-100)

21 (34.4, 22.7-47.7)

  Disease control

1 (100, 2.5-100)

7 (63.6, 30.8-89.1)

19 (100, 82.4-100)

22 (84.6, 65.1-95.6)

3 (100, 29.2-100)

1 (100, 2.5-100)

53 (86.9, 75.8-94.2)

Stable disease in bone at week 12

3 (100, 29.2-100)

35 (89.7, 85.5-99.9)

66 (90.4, 81.2-96.1)

64 (84.2, 80.7-95.9)

3 (100, 29.2-100)

3 (100, 29.2-100)

174 (88.3, 87.2-95.5)