Table 2.

Endpoints of Phase III studies of sipuleucel-T versus placebo

	D9901	D9902A	IMPACT Pre-amendment	IMPACT post-amendment
Study population (n = sipuleucel-T/control)	Asymptomatic mCRPC (n=82/45)	Asymptomatic mCRPC (n=65/33)	Asymptomatic mCRPC (n=135/68)	Asymptomatic or minimally symptomatic mCRPC (n=206/103)
Primary endpoint	Time to progression	Time to progression	Time to progression and time to disease-related pain	Overall survival
Secondary endpoints	Time to disease-related pain, overall survival	Time to disease-related pain, overall survival	Time to use of first opiate analgesic use	Time to disease progression

Abbreviations: IMPACT, Immunotherapy for Prostate Adenocarcinoma Treatment; mCRPC, metastatic castration-resistant prostate cancer.