. 2013 Jan;5(1):25–40. doi: 10.1177/1758834012458137

Table 3.

Selected ongoing and completed phase III clinical trials in castration-resistant prostate cancer.

Phase III trial	Arms	Patient population	Primary endpoints	Secondary endpoints
Recruiting trials
PREVAIL	MDV3100 versus placebo	mCRPC chemonaïve whose condition failed to respond to ADT	OS	Time to first SRE, time to cytotoxic chemotherapy
NCT01212991	MDV3100 versus placebo	mCRPC chemonaïve whose condition failed to respond to ADT	PFS	Time to first SRE, time to cytotoxic chemotherapy
PROSPECT	PROSTVAC-V/F ± GM-CSF versus placebo	Asymptomatic or minimally symptomatic mCRPC	OS	Event-free patients
NCT01322490	PROSTVAC-V/F ± GM-CSF versus placebo	Asymptomatic or minimally symptomatic mCRPC	OS	Event-free patients
SYNERGY	Docetaxel/prednisone versus docetaxel/prednisone in combination with OGX-011	mCRPC chemonaïve whose condition failed to respond to ADT	OS	PFS at days 140, 225; PSA measurements; safety
NCT01188187		mCRPC chemonaïve whose condition failed to respond to ADT	OS	PFS at days 140, 225; PSA measurements; safety
NCT01057810	Ipilimumab versus placebo	mCRPC chemonaïve whose condition failed to respond to ADT	OS	PFS, time to pain progression, time to subsequent treatment, safety
FIRSTANA	Cabazitaxel at 20 mg/m² or 25 mg/m² + prednisone versus docetaxel + prednisone	mCRPC chemonaïve whose condition failed to respond to ADT	OS	PFS
NCT01308567		mCRPC chemonaïve whose condition failed to respond to ADT	OS	PFS
PROSELICA	Cabazitaxel at 20 mg/m² + prednisone versus cabazitaxel at 25 mg/ m²	mCRPC previously treated with docetaxel	Noninferiority of 2 doses	Efficacy (PFS) and safety
NCT01308580		mCRPC previously treated with docetaxel	Noninferiority of 2 doses	Efficacy (PFS) and safety
NCT00861614	Ipilimumab versus placebo	mCRPC post docetaxel	OS	PFS, pain, safety profile
NCT01193257	Orteronel + prednisone versus placebo + prednisone	mCRPC post docetaxel	OS	50% PSA response at 12 weeks, pain response at 12 weeks, radiographical PFS
COMET-2	XL184 versus mitoxantrone	Symptomatic mCRPC post docetaxel	Pain response at 12 weeks	Bone scan response, OS
NCT01522443	XL184 versus mitoxantrone	Symptomatic mCRPC post docetaxel	Pain response at 12 weeks	Bone scan response, OS
Completed trials
MAINSAIL	Lenalidomide + docetaxel + prednisone versus placebo + docetaxel + prednisone	mCRPC chemonaïve whose condition failed to respond to ADT	OS	PFS, ORR, safety
NCT00988208
(discontinued negative)
AA-COU-302	Abiraterone acetate versus placebo	Asymptomatic or minimally symptomatic mCRPC, chemonaïve	OS	Time to opiate use, cytotoxic chemotherapy use and PSA progression
NCT00887198			PFS
(unblinded; positive)
VENICE	Docetaxel + prednisone + aflibercept versus docetaxel + prednisone + placebo	CRPC in addition to docetaxel/prednisone	OS	PSA measurement, pain, occurrence of SREs
NCT00519285			(primary endpoint was not met)
(negative)
NCT00286091	Denosumab versus placebo	CRPC without bone metastasis (high risk for development of bone metastasis)	Bone metastasis-free survival
(positive)	Denosumab versus placebo		Bone metastasis-free survival
NCT01193244	Orteronel + prednisone versus placebo + prednisone	Chemonaïve mCRPC	OS, radiographical PFS	50% PSA response at 12 weeks, change in CTC counts, time to pain progression
NCT00744497	Docetaxel + prednisone + dasatinib versus docetaxel + prednisone + placebo	mCRPC with docetaxel	OS	Tumor response rate, time to first SRE, time to PSA progression, PFS, safety
ENTHUSE-M1	Zibotentan versus placebo	mCRPC with bone metastasis, minimally symptomatic with no pain	OS	PFS, tolerability, incidence of SREs, bone metastases, time to PSA progression, time to pain progression, time to initiation of chemotherapy
NCT00554229
(negative)
NCT00134056	Docetaxel + prednisone + atrasantan versus docetaxel + prednisone + placebo	mCRPC with bone metastasis	OS, PFS	Pain progression, toxicity, quality of life, PSA response
(negative)		mCRPC with bone metastasis	OS, PFS	Pain progression, toxicity, quality of life, PSA response

ADT, androgen deprivation therapy; CRPC, castration-resistant prostate cancer; GM-CSF, granulocyte macrophage colony-stimulating factor; mCRPC, metastatic castration-resistant prostate cancer; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PSA, prostate-specific antigen; SRE, skeletal-related event.