Table 1: Selected ongoing and recently concluded phase III trials in castration refractory prostate cancer.

TargetDrugTrialPhasePrimary endpointClinical trial identifier number (accessed on January 22, 2013)Outcome

Androgen dependent pathways

CYP17Orteronel (TAK-700)Randomized, double-blind, orteronel plus prednisone versus placebo plus prednisone in mCRPC with prior docetaxel therapy
IIIOSNCT01193257Ongoing
Orteronel (TAK-700)Randomized, double-blind, orteronel plus prednisone versus placebo plus prednisone in progressive, chemotherapy naive mCRPCIIIOSNCT01193244Ongoing
AbirateroneRandomized, double-blind, prednisone and abiraterone or placebo and prednisone in mCRPC after failed docetaxelIIIOSNCT00638690Improved OS with abiraterone
AbirateroneRandomized, double-blind, prednisone and abiraterone or placebo and prednisone in chemotherapy naive mCRPC IIIPFSNCT00887198Improved radiographic PFS with abiraterone

AREnzalutamide (MDV 3100)Randomized, double-blind, MDV3100 versus placebo in chemotherapy naive progressive mCRPCIIIOS, PFSNCT01212991Ongoing
Enzalutamide (MDV 3100)Randomized, double-blind, MDV3100 versus placebo in mCRPC with prior docetaxelIIIOSNCT00974311Improved OS with enzalutamide

Androgen independent pathways

Src kinaseDasatinibRandomized, double-blinded, docetaxel, prednisone, and dasatinib versus docetaxel, prednisone, and placebo in mCRPC IIIOSNCT00744497No difference in OS

c-METCabozantinibRandomized, placebo controlled of mitoxantrone and prednisone versus cabozantinib in mCRPCIIIPain responseNCT01522443Ongoing
CabozantinibRandomized, placebo controlled prednisone versus cabozantinib in mCRPC with prior docetaxel and abiraterone or MDV3100IIIOSNCT01605227Ongoing

ClusterinCustirsen (OGX-011)Randomized, open label with cabazitaxel and prednisone with or without custirsen in second line chemotherapy in mCRPC IIIOSNCT01578655Ongoing
Custirsen (OGX-011)Randomized, docetaxel and prednisone with and without custirsen in chemotherapy naïve mCRPCIIIOSNCT01188187Ongoing
Custirsen (OGX-011)Randomized, docetaxel retreatment or cabazitaxel and prednisone with and without custirsen in mCRPC IIIPain responseNCT01083615Ongoing

VEGFBevacizumab (VEGF antibody)Randomized, double-blinded, docetaxel and prednisone with and without bevacizumab in mCRPC IIIOSNCT00110214No difference in OS
Aflibercept (VEGF trap)Randomized, double-blind, aflibercept versus placebo in mCRPC with ongoing docetaxel and prednisoneIIIOSNCT00519285No difference in OS
Sunitinib (VEGF tyrosine kinase inhibitor)Randomized, double-blind, sunitinib and prednisone versus prednisone in mCRPC with prior docetaxelIIIOS NCT00676650No difference in OS

ImmunotherapyProstvac-VFRandomized Prostvac-VF with and without GM-CSF in chemotherapy naive mCRPCIIIOSNCT01322490Ongoing
IpilimumabRandomized ipilimumab versus placebo in chemotherapy naive mCRPCIIIOSNCT01057810Ongoing
IpilimumabRandomized ipilimumab versus placebo in mCRPC following radiotherapy with prior docetaxelIIIOSNCT00861614Ongoing
TasquinimodRandomized tasquinimod versus placebo in chemotherapy naive mCRPCIIIPFSNCT01234311Ongoing

CYP17: Cytochrome P450 17 alpha-hydroxylase and C17,20-lyase; mCRPC: metastatic castration refractory prostate cancer; AR: androgen receptor; OS: overall survival; PFS: progression free survival; c-MET: hepatocyte growth factor receptor; VEGF: vascular endothelial growth factor.