Table 2. Primary and secondary outcome measures.
| Short-course ADT (n=761) | Long-course ADT (n=743) | HR (95% CI)* | Log-rank p value* | Proportional hazards p value† | |
|---|---|---|---|---|---|
| Metastasis-free survival | |||||
| Events | 174 | 139 | 0·773 (0·612–0·975) | 0·029 | 0·078 |
| Metastases first | 112 | 70 | ·· | ·· | ·· |
| Prostate cancer death first | 5 | 6 | ·· | ·· | ·· |
| Death from other causes first | 57 | 63 | ·· | ·· | ·· |
| RMST (95% CI)‡ | 8·87 (8·70–9·03) | 9·12 (8·97–9·27) | ·· | ·· | ·· |
| 10-year metastasis-free survival (95% CI) | 71·9% (67·6–75·7) | 78·1% (74·2–81·5) | ·· | ·· | ·· |
| Overall survival | |||||
| Events | 111 | 100 | 0·880 (0·663–1·169) | 0·38 | 0·56 |
| RMST (95% CI)‡ | 9·39 (9·27–9·51) | 9·45 (9·34–9·57) | ·· | ·· | ·· |
| 10-year overall survival (95% CI) | 82·0% (78·3–85·2) | 84·6% (81·0–87·5) | ·· | ·· | ·· |
| Freedom from distant metastasis | |||||
| Events | 117 | 76 | 0·634 (0·471–0·853) | 0·0024 | 0·15 |
| RMST (95% CI)‡ | 9·16 (9·00–9·31) | 9·47 (9·34–9·59) | |||
| 10-year freedom from distant metastasis (95% CI) | 80·8% (77·0–84·1) | 87·6% (84·4–90·2) | ·· | ·· | ·· |
| Clinical progression-free survival | |||||
| Events | 222 | 173 | 0·728 (0·592–0·895) | 0·0024 | <0·0001 |
| RMST (95% CI)‡ | 8·12 (7·90–8·34) | 8·73 (8·55–8·91) | ·· | ·· | ·· |
| 10-year clinical progression-free survival (95% CI) | 66·5% (62·4–70·3) | 73·1% (69·1–76·6) | ·· | ·· | ·· |
| Time to non-protocol ADT | |||||
| Events | 200 | 157 | 0·733 (0·591–0·910) | 0·0047 | 0·0001 |
| RMST (95% CI)‡ | 8·32 (8·11–8·53) | 8·83 (8·66–9·01) | ·· | ·· | ·· |
| 10-year freedom from non-protocol ADT (95% CI) | 68·5% (64·2–72·4) | 75·1% (71·2–78·5) | ·· | ·· | ·· |
ADT=androgen deprivation therapy. HR=hazard ratio. RMST=restricted mean survival time.
*
Adjusted for randomisation stratification factors.
†
Grambsch–Therneau test of non-proportional hazards.
‡
Restricted to 10 years.