Table 1.
Comparison of the STAMPEDE and LATITUDE trials
| STAMPEDE (James et al, 2017) | LATITUDE (Fizazi et al, 2017) | |
|---|---|---|
| Patient population | Non-metastatic, node neg: 28%; non-metastatic, node pos: 20%; metastatic: 52% | Metastatic: 100% |
| Study design | Randomized, Phase III trial with multi-group, multistage platform design | Randomized, Phase III controlled trial |
| Primary endpoints | Overall survival; failure-free survival | Overall survival; r-PFS |
| Study treatment | ADT + abiraterone/prednisolonea + radiotherapy (in non-metastatic patients) | ADT + abiraterone/prednisonea |
| Control treatment | ADT + radiotherapy (in non-metastatic patients) | ADT + dual placebos (for abiraterone and prednisone) |
| Treatment duration | Non-metastatic and radiotherapy: 2 years (planned); metastatic or non-metastatic, but not radiotherapy: until progression | Until progression |
| Total sample size | 1,917 (1,002 metastatic patients) | 1,199 |
| HR for death (95% CI) | 0.63 (0.52–0.76), favoring abiraterone | 0.62 (0.51–0.76) favoring abiraterone |
| Other primary endpoints | r-PFS: HR=0.47 | Treatment failure HR=0.29, with evidence of non-proportional hazards |
Note:
a
Prednisolone and prednisone are standard, co-administered medications used with abiraterone to prevent hyperaldosteronism (negative feedback).
Abbreviations: ADT, androgen deprivation therapy; neg, negative; pos, positive; r-PFS, radiographic progression-free survival.