TABLE V.

Ongoing trials of enzalutamide combined with radiotherapy (RT) in prostate cancer (PCa)

ClinicalTrials.gov ID (study name)	Phase	Eligibility	Pts (n)	Study arms	Status	Endpoints
						Primary	Secondary
NCT02023463	I	Intermediate-risk or high-risk PCa	25	Enzalutamide, ADT, and RT	Active, not recruiting	Acute toxicities	Serum PSA and quality of life
NCT02028988	II	Intermediate-risk PCa	64	Enzalutamide and RT	Active, not recruiting	Serum PSA after 6 months of enzalutamide therapy	Quality of life, hormone levels, and body fat
NCT02057939 (STREAM)	II	Biochemical relapse after partial response	38	Enzalutamide, ADT, and salvage RT	Active, not recruiting	Progression-free survival	Biochemical progression-free survival, progression-free survival, PSA <0.1 ng/mL, PSA nadir, and time to testosterone recovery
NCT02064582	II	High-risk PCa	9	Enzalutamide, ADT, and RT	Active, not recruiting	Assess the safety and tolerability of combining enzalutamide, ADT, and RT	Assessing intratumoural androgen-regulated gene expression before and after combination therapy
NCT02203695	II	Biochemical relapse after partial response	122	(A) Salvage RT and placebo (B) Salvage RT and enzalutamide	Recruiting	Freedom from PSA progression	Metastasis-free survival rate and local recurrence
NCT02446444 (ENZARAD) (ANZUP 1303)	III	High-risk PCa	802	(A) Enzalutamide, ADT, and RT (B) Nonsteroidal anti-androgen, ADT, and RT	Active, not recruiting	Overall survival	Biochemical progression-free survival, progression-free survival, and metastasis-free survival
NCT02508636	II	High-risk PCa	11	Enzalutamide, ADT, and RT	Active, not recruiting	Rate of acute toxicity Rate of late toxicity PSA complete response rate	Biochemical progression-free survival, disease-free survival, time to clinical progression, and quality of life
NCT03196388 (ENZART)	II	Intermediate-risk PCa	70	Enzalutamide and RT	Recruiting	80% Reduction from baseline PSA

Pts = patients; PSA = prostate-specific antigen; ADT = androgen deprivation therapy.