Table 2. Participant characteristics denoting metastasis risk.

Trial	Stage and high risk definition	Hormone status	Gleason score > 7	Median PSA at randomization (μg/L)	N+ disease	T3/4 disease	Prostatectomy and/or radiotherapy
Zometa 704 [16, 17]	M0; rising PSA despite ADT	Castrate resistant	29%	13.8	17%	NR	34%
MRC PR04 [18, 19]	M0; T2–4	Castrate sensitive	NR	13.0 (TG); 10.0 (CG)	3%	47%	71%
Smith 2012 [13]	M0; rising PSA despite ADT; PSA ≥8 μg/L and/or PSA DT ≤10 mo	Castrate resistant	32%	12.2	13%	NR	45%
TROG 03.04 RADAR [20]	M0; T2a (Gleason >7 and PSA ≥10 μg/L); or T2b–4, N0	Castrate sensitive	35%	14.0–15.0*	0%‡	37%	Radiotherapy planned in 98%
ZEUS [21]	M0; Gleason 8–10 or pN+ or PSA at diagnosis >20 μg/L	Castrate sensitive	62%	40.0†	24%	NR	55%
STAMPEDE [22]	M1 or M0; high-risk (at least two of T3/4, Gleason 8–10 or PSA ≥40 μg/L) starting ADT	Castrate sensitive	71%	65.0	50%	82%	60%§

Abbreviations: M0, non-metastatic; M1, distant metastatic disease; PSA, prostate specific antigen; DT, doubling time; ADT, androgen deprivation therapy; TG, treatment group; CG, control group; SOC, standard of care; NR, not reported

* 14.9 (Short term androgen suppression control group), 14.0 (Short term androgen suppression treatment group), 15.0 (Intermediate term androgen suppression control group), 14.0 (Intermediate term androgen suppression treatment group)

^† Mean PSA at diagnosis

^‡ N+ disease excluded

^§ Radiotherapy reported in 60% of M0 cohort