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. 2018 Nov 11;10(12):445–454. doi: 10.1177/1756287218811450

Table 1.

Important phase III trials of apalutamide.

Acronym Identifier Patient population Comparator arms Primary endpoint
ACIS NCT02257736 mCRPC Apalutamide/abiraterone/prednisone versus
placebo/abiraterone/prednisone
Radiographic progression-free survival
TITAN NCT02489318 mHSPC Apalutamide/ADT
versus
placebo/ADT
Radiographic progression-free survival and overall survival
ATLAS NCT02531516 High-risk or locally advanced prostate cancer Apalutamide/ADT + RT
versus
bicalutamide/ADT + RT
Metastasis-free survival
EORTC NCT03488810 Intermediate and limited high-risk prostate cancer Apalutamide/ADT + RT
versus
nonsteroidal anti-androgen / ADT + RT
Disease-free survival
ALLIANCE NCT03009981 Biochemically recurrent prostate cancer with PSA doubling time ⩽9 months Degarelix
versus
degarelix/apalutamide
versus degarelix/apalutamide/abiraterone/prednisone
PSA progression-free survival
SPARTAN NCT01946204 nmCRPC Apalutamide/ADT
versus
placebo/ADT
Metastasis-free survival

ADT, androgen deprivation therapy; mCRPC, metastatic castrate-resistant prostate cancer; mHSPC, metastatic hormone-sensitive prostate cancer; nmCRPC, nonmetastatic castrate-resistant prostate cancer; PSA, prostate-specific antigen; RT, radiotherapy.