Table. Baseline Characteristics of Eligible Patients Who Received Allocated Intervention.
| Characteristic | ADT Plus Docetaxel (n = 125) | ADT (n = 125) |
|---|---|---|
| Age, median (IQR), y | 64 (58-70) | 66 (61-71) |
| ECOG-PS, No. (%) | ||
| 0 | 119 (95.2) | 116 (92.8) |
| 1 | 4 (3.2) | 8 (6.4) |
| Stage T3/T4, No. (%) | 73 (58.4) | 74 (59.2) |
| Prior radical prostatectomy, No. (%) | 90 (72.0) | 92 (73.6) |
| Prior radiotherapy ± ADT, No. (%) | 35 (28.0) | 33 (26.4) |
| Salvage radiotherapy, No. (%) | 54 (43.2) | 56 (44.8) |
| Baseline measurements, median (IQR) | ||
| PSA level, ng/mL | 2.6 (1.0-6.2) | 2.9 (1.0-6.0) |
| PSA-DT, mo | 5.8 (3.2-8.4) | 5.8 (3.7-9.1) |
| PSA velocity, ng/mL per year | 1.4 (1.0-1.0) | 1.4 (1.0-1.0) |
| Testosterone, ng/dL | 420.5 (334.1-636.5) | 414.7 (371.5-699.8) |
| Time RP/RT to PSA progression, mo | 30 (17.0-51.5) | 27 (16.5-43.7) |
| High-risk factors at inclusion, No. (%) | ||
| Gleason score ≥8 | 41 (32.8) | 36 (28.8) |
| PSA-DT ≤6 mo | 67 (53.6) | 67 (53.6) |
| PSA velocity >0.75 ng/mL per year | 106 (84.8) | 101 (80.8) |
| Positive surgical margins | 45 (36.0) | 49 (39.2) |
| Node positive | 4 (3.2) | 6 (4.8) |
| Median time RP/RT to PSA progression ≤12 mo | 19 (15.2) | 21 (16.8) |
| At least 4 high-risk factors | 13 (10.4) | 17 (13.6) |
Abbreviations: ADT, androgen-deprivation therapy; DT, doubling time; ECOG-PS, Eastern Cooperative Oncology Group performance status; IQR, interquartile range; PSA, prostate-specific antigen; RP, radical prostatectomy; RT, radiotherapy.
SI conversion: To convert PSA to micrograms per liter, multiply by 1; testosterone to nanomoles per liters, multiply by 0.0347.