. Author manuscript; available in PMC: 2023 Jun 10.

Published in final edited form as: Clin Genitourin Cancer. 2022 Jun 30;20(6):515–523. doi: 10.1016/j.clgc.2022.06.016

Table 1.

Clinical Trials Demonstrating Benefit of Early Intensification in mHSPC Patients.

Trial	Progression Free Survival Definition			Treatment Arm (PFS, in months)	Control Arm (PFS, in months)	HR	P-value
	Clinical	Biochemical	Radiographic	Treatment Arm (PFS, in months)	Control Arm (PFS, in months)	HR	P-value
CHAARTED⁷	x	x	X	Docetaxel ± ADT Time to CRPC^: 20.2 Time to clinical progression^*: 33.0	ADT Time to CRPC^: 11.7 Time to clinical progression^*: 19.8	0.61	< .0001
STAMPEDE¹	x	x	x	Abiraterone ± prednisolone ± ADT 43.9	ADT 30.0	0.40	< .001
LATITUDE⁸			x	Abiraterone ± prednisone ± ADT 33.0	ADT 14.8	0.47	< .001
ENZAMET²	x	x	x	Enzalutamide ± ADT ±/− docetaxel PSA PFS: 67% at 3 yrs (HR 0.39, P <.001) Clinical PFS^***: 68% at 3 yrs (HR 0.40, P < .001)	ADT ± NSAA ±/− docetaxel PSA PFS: 37% at 3 yrs (HR 0.39, P <.001) Clinical PFS: 41% at 3 yrs (HR 0.40, P < .001)
ARCHES⁹			x	Enzalutamide ± ADT Not reached	ADT 19.0	0.39	< .001
TITAN³			x	Apalutamide ± ADT Could not be estimated	ADT 22.1	0.48	< .001
PEACE 1⁶			x	Abiraterone ± prednisone ± ADT ± Docetaxel ±/− local radiotherapy 4.5 yrs	ADT ± Docetaxel ±/− local radiotherapy 2.0 years	0.50	< .0001
ARASENS⁵	x			Darolutamide ± ADT ± Docetaxel Time to CRPC^*: Not reached	Placebo ± ADT ± Docetaxel Time to CRPC^*: 19.1	0.36	< .001

Time to CRPC defined as time to clinical deterioration, radiographic progression, serologic progression, or death due to any cause.

^**

Clinical progression defined as time to clinical deterioration, radiographic progression, or death due to any cause.

^***

Based on clinical symptoms, radiographic progression, or change in therapy.Abbreviations: ADT = androgen deprivation therapy, CRPC = Castrate Resistant Prostate Cancer, NSAA = Nonsteroidal antiandrogen, PFS= progression free survival.