Baseline demographics and characteristics in the full analysis set, the testosterone subset, and the PSA subset
| Characteristics | FAS (n = 294) | Testosterone subset† (n = 80) | PSA subset† (n = 107) |
|---|---|---|---|
| Mean age ± SD, years | 70.2 ± 7.7 | 68.9 ± 6.9 | 68.9 ± 6.6 |
| ECOG score, n (%) | |||
| 0 | 152 (51.7) | 47 (58.8) | 58 (54.2) |
| 1 | 131 (44.6) | 32 (40.0) | 46 (43.0) |
| 2–3 | 11 (3.7) | 1 (1.3) | 3 (2.8) |
| Mean serum PSA ± SD, ng/mL | 36.7 ± 88.8 | – | 39.5 ± 116.4 |
| Mean serum testosterone ± SD, ng/dL | 574.5 ± 2,053.5 | 392.2 ± 169.8 | – |
| Disease status, n (%) | |||
| Localized | 135 (45.9) | 35 (43.8) | 49 (45.8) |
| Locally advanced | 159 (54.1) | 45 (56.3) | 58 (54.2) |
| RP status, n (%) | |||
| RP | 182 (61.9) | 57 (71.3) | 80 (74.8) |
| No RP | 112 (38.1) | 23 (28.8) | 27 (25.2) |
| T staging, n (%) | |||
| T1–2 | 108 (36.7) | 31 (38.8) | 39 (36.4) |
| T3–4 | 161 (54.8) | 45 (56.3) | 60 (56.1) |
| Missing | 25 (8.5) | 4 (5.0) | 8 (7.5) |
| N staging, n (%) | |||
| N0 | 221 (75.2) | 60 (75.0) | 79 (73.8) |
| N1 | 35 (11.9) | 12 (15.0) | 15 (14.0) |
| Nx | 18 (6.1) | 7 (8.8) | 7 (6.5) |
| Missing | 20 (6.8) | 1 (1.3) | 6 (5.6) |
| Gleason score, n (%) | |||
| 6 | 19 (6.5) | 4 (5.0) | 6 (5.6) |
| 7 | 110 (37.4) | 30 (37.5) | 43 (40.2) |
| 8 | 77 (26.2) | 18 (22.5) | 25 (23.4) |
| ≥ 9 | 76 (25.9) | 23 (28.8) | 27 (25.2) |
| Missing | 3 (1.0) | 1 (1.3) | 1 (0.9) |
↵†The testosterone and PSA subsets consisted of all patients who completed the three tests for serum testosterone and PSA, respectively, at baseline, week 12 ± 2, and week 24 ± 2. ECOG, Eastern Cooperative Oncology Group; PSA, prostate-specific antigen; RP, radical prostatectomy; SD, standard deviation.