Table 2.

Comparison Of Main Characteristics And Outcomes Of The Pivotal Phase III Trials For nmCRPC

Drug Name	PROSPER Trial32	SPARTAN Trial33	ARAMIS Trial34
Enzalutamide	Apalutamide	Darolutamide
Design	Phase III trial Placebo-controlled 2:1 randomization ratio	Phase III trial Placebo-controlled 2:1 randomization ratio	Phase III trial Placebo-controlled 2:1 randomization ratio
Sample size	1,401	1,207	1,509
Population	High-risk nmCRPC (PSAdt < 10 months)	High-risk nmCRPC (PSAdt < 10 months)	High-risk nmCRPC (PSAdt < 10 months)
N1 disease	Not included	Included (< 2 cm)	Included (< 2 cm)
1 endpoint	Metastasis-free survival	Metastasis-free survival	Metastasis-free survival
Median time to PSA progression (months)	37.2 vs 3.9 mo (P<0.001)	NR vs 3.7 mo	33.2 vs 7.3 mo (P<0.001)
Median MFS (months)	36.6 vs 14.7 mo (P<0.001)	40.5 vs 16.2 mo (P<0.001)	40.4 vs 18.4 mo (P<0.001)
Overall Survival (months)	NR vs NR (P>0.05*)	NR vs 39 (P=0.07*)	NR vs NR (P= 0.045*)

Note: *not statistically significant with current follow-up.

Abbreviations: N1, loco-regional (pelvic) lymph node metastasis; MFS, metastasis-free survival; AE, adverse events; nmCRPC, non-metastatic castration-resistant prostate cancer; NR, not reached.