Randomized, Open-Label Phase 2 Study of Apalutamide plus Androgen Deprivation Therapy versus Apalutamide Monotherapy versus Androgen Deprivation Monotherapy in Patients with Biochemically Recurrent Prostate Cancer
Table 3
Demographic and baseline characteristics (intent-to-treat population).
Baseline patient characteristic
Apalutamide + ADT (n = 31)
Apalutamide (n = 29)
ADT (n = 30)
Median age, years (range)
67.0 (54–78)
66.0 (55–79)
68.5 (46–80)
Race
White
29 (93.5%)
26 (89.7%)
26 (86.7%)
Asian
1 (3.2%)
1 (3.4%)
2 (6.7%)
Black or African American
1 (3.2%)
1 (3.4%)
0
Unknown
0
1 (3.4%)
2 (6.7%)
Median time from initial diagnosis to randomization, years (range)
6.1 (0.9–22.0)
5.7 (0.6–15.7)
6.0 (2.2–15.3)
ECOG performance status
0
30 (96.8%)
27 (93.1%)
24 (80.0%)
1
1 (3.2%)
2 (6.9%)
6 (20.0%)
Tumor stage at initial diagnosis
T1
0
1 (3.4%)
0
T1C
5 (16.1%)
2 (6.9%)
3 (10.0%)
T2
1 (3.2%)
1 (3.4%)
2 (6.7%)
T2A
1 (3.2%)
4 (13.8%)
1 (3.3%)
T2B
2 (6.5%)
3 (10.3%)
0
T2C
9 (29.0%)
8 (27.6%)
11 (36.7%)
T3
1 (3.2%)
1 (3.4%)
0
T3A
5 (16.1%)
3 (10.3%)
7 (23.3%)
T3B
7 (22.6%)
6 (20.7%)
6 (20.0%)
Gleason score at initial diagnosis
n
31
27
29
≤7
20 (64.5%)
16 (59.3%)
20 (66.7%)
≥8
11 (35.5%)
11 (40.7%)
9 (31.0%)
Median PSA at randomization, µg/L (range)
4.1 (1.2–38.8)
2.7 (1.0–42.3)
4.0 (1.2–29.8)
PSA doubling time
<6 months
21 (67.7%)
20 (69.0%)
19 (63.3%)
≥6 months
10 (32.3%)
9 (31.0%)
11 (36.7%)
Risk categories∗
Low
0
3 (10.3%)
1 (3.3%)
Intermediate
15 (48.4%)
14 (48.3)
15 (50.0%)
High
16 (51.6%)
12 (41.4%)
14 (46.7%)
Prior radical prostatectomy†
28 (90.3%)
23 (79.3%)
24 (80.0%)
Prior radiation therapy†
25 (80.6%)
25 (86.2%)
29 (96.7%)
Primary
4 (12.9%)
6 (20.7%)
5 (16.7%)
Salvage
20 (64.5%)
18 (62.1%)
22 (73.3%)
Other
3 (9.7%)
2 (6.9%)
2 (6.7%)
Adjuvant
2 (6.5%)
2 (6.9%)
1 (3.3%)
Pretreatment for brachytherapy
1 (3.2%)
0
0
Metastatic disease/palliative
0
0
1 (3.3%)
Radical prostatectomy and salvage radiation therapy
18 (58.1%)
17 (58.6%)
21 (70.0%)
Baseline FACT-P total score‡
n
30
28
28
Median
131.2
125.0
127.0
Range
82.0–144.0
81.8–150.0
92.7–150.0
∗ Based on European Association of Urology Prostate Cancer guidelines [26]. † Patients with multiple therapies were counted only once. ‡The scoring range of the FACT-P total score for each patient is 0–156, with higher scores indicating better HRQoL and higher treatment tolerability. ECOG : Eastern Cooperative Oncology Group.
