From Bench to Bedside: Immunotherapy for Prostate Cancer

Table 1

Key clinical trials based on the 4 selected immunotherapies for PCa.

Drug	Trial design	Number of patients	Phase	Key finding	Reference
Sipuleucel-T	Randomized, double blind, placebo controlled trial for asymptomatic metastatic CRPC	127	III	Improved OS by sipuleucel-T compared to placebo (25.9 versus 21.4 months)	[17]
	Randomized, double blind, placebo controlled trial for asymptomatic metastatic CRPC	98	III	Improved OS by sipuleucel-T compared to placebo (19 versus 15.7 months)	[18]
	Randomized, double blind, placebo controlled trial for asymptomatic metastatic CRPC	512	III	Improved OS by sipuleucel-T compared to placebo (25.8 versus 21.7 months)	[19]
Ipilimumab	Randomized, double blind, placebo-controlled trial for metastatic CRPC after docetaxel	799	III	No difference in OS between the 2 groups, but trend of improved PFS rate by ipilimumab at 6 months (30.7% versus 18.1%)	[20]
Prostvac-VF	Randomized placebo-controlled trial of Prostvac-VF for metastatic CRPC	125	II	Improved OS by Prostvac-VF compared to control vector placebo (25.1 versus 16.6 months)	[21]
	Nonrandomized trial for chemotherapy-naive CRPC	32	II	Improved OS by Prostvac-VF compared to historical controls (Halabi nomogram): (26.6 versus 17.4 months)	[22]
GVAX	Randomized trial of GVAX with docetaxel versus docetaxel with prednisone in taxane-naïve patients with symptomatic CRPC	408	III	Trial terminated early due to excess deaths in GVAX plus docetaxel group compared to control (docetaxel plus prednisone) (67 versus 47), and shorter median OS (12.2 versus 14.1 months).	[23]
	Randomized trial of GVAX with docetaxel versus docetaxel with prednisone in taxane-naïve patients with asymptomatic CRPC	626	III	Trial terminated early based on futility analysis showing <30% chance of meeting primary endpoint (improved OS)	[24]