Abiraterone acetate for early stage metastatic prostate cancer: patient selection and special considerations

Figures & data

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.