Table 1.
Characteristics of clinical trials included in this study.
| Clinical trail | Design | Sources of patients | Follow-up (median, month) | Intervention | Control | Number of patients∗ | Age (median, years)∗ | Gleason score (median) | PSA level (median, ng/ml) | ECOG PS (range) |
|---|---|---|---|---|---|---|---|---|---|---|
| D9902B NCT00065442 | Phase 3 | 75 centers in the United States and Canada | 34.1 | Sipuleucel-T (3 complete doses/2 weeks) | APC placebo (3 complete doses/2 weeks) | 341:171 | 72:70 | NR | NR | 0 to 1 |
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| D9901 NCT00005947 | Phase 3 | 19 centers in the United States | 36 | Sipuleucel-T (3 complete doses/2 weeks) | APC placebo (3 complete doses/2 weeks) | 82:45 | 73:71 | 7:7 | 46.0:47.9 | 0 to 1 |
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| D9902A NCT01133704 | Phase 3 | 24 clinical trial sites | 36 | Sipuleucel-T (3 complete doses/2 weeks) | APC placebo (3 complete doses/2 weeks) | 65:33 | 70:71 | NR | 61.3:44.0 | 0 to 1 |
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| PREVAIL NCT01212991 | Phase 3 | 207 sites in 22 countries | 31 | Enzalutamide (160 mg/d) | Placebo | 872:845 | 72:71 | NR | 54.1:44.2 | 0 to 1 |
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| COU-AA-302 NCT00887198 | Phase 3 | 12 countries | 49.2 | Abiraterone (1000 mg/d) plus prednisone (10 mg/d) | Prednisone (10 mg/d) | 546:542 | 71:70 | NR | 42:37.7 | 0 to 1 |
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| TAX 327 Tannock et al. | Phase 3 | 24 countries | 20.8 | Docetaxel (75 mg/m2)/3 weeks plus prednisone (10 mg/d) | Mitoxantrone (12 mg/m2)/3 weeks plus prednisone (10 mg/d) | 335:337 | 68:68 | NR | 114:123 | NR |
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| Shen et al. | RCT | Single center | 16.8 | Docetaxel (75 mg/m2)/3 weeks plus prednisone (10 mg/d) | Mitoxantrone (12 mg/m2)/3 weeks plus prednisone (10 mg/d) | 30:31 | 64:66 | NR | 63.45:100.86 | NR |
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| Zhou et al. NCT00436839, |
RCT | 15 centers in China | 60 | Docetaxel (75 mg/m2)/3 weeks plus prednisone (10 mg/d) | Mitoxantrone (12 mg/m2)/3 weeks plus prednisone (10 mg/d) | 113:115 | 70.7:70.8 | 8:8 | 70.9:100 | NR |
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| FIRSTANA NCT01308567 | RCT | 159 centers in 25 countries | 51 | Cabazitaxel (20 mg/m2)/3 weeks plus prednisone (10 mg/d) | Docetaxel (75 mg/m2)/3 weeks plus prednisone (10 mg/d) | 389:391 | NR | NR | NR | 0 to 2 |
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| WILLIAM BERRY | Phase 3 | Multicenter in the United States | 21.8 | Mitoxantrone (12 mg/m2)/3 weeks plus prednisone (10 mg/d) | Prednisone (10 mg/d) | 56:63 | 70:74 | NR | 56.7:71.0 | 0 to 2 |
PSA: prostate specific antigen; ECOG PS: Eastern Cooperative Oncology Group Performance Status; NR: not reported; RCT: randomized controlled trial. ∗Intervention versus control.