BioMed Research International / 2014 / Article / Tab 1

Review Article

From Bench to Bedside: Immunotherapy for Prostate Cancer

Table 1

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

DrugTrial designNumber of patientsPhaseKey findingReference

Sipuleucel-TRandomized, double blind, placebo controlled trial for asymptomatic metastatic CRPC127IIIImproved OS by sipuleucel-T compared to placebo (25.9 versus 21.4 months)[17]
Randomized, double blind, placebo controlled trial for asymptomatic metastatic CRPC98IIIImproved OS by sipuleucel-T compared to placebo (19 versus 15.7 months) [18]
Randomized, double blind, placebo controlled trial for asymptomatic metastatic CRPC512IIIImproved OS by sipuleucel-T compared to placebo (25.8 versus 21.7 months)[19]

IpilimumabRandomized, double blind, placebo-controlled trial for metastatic CRPC after docetaxel 799IIINo 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-VFRandomized placebo-controlled trial of Prostvac-VF for metastatic CRPC125IIImproved OS by Prostvac-VF compared to control vector placebo (25.1 versus 16.6 months) [21]
Nonrandomized trial for chemotherapy-naive CRPC32IIImproved OS by Prostvac-VF compared to historical controls (Halabi nomogram): (26.6 versus 17.4 months)[22]

GVAXRandomized trial of GVAX with docetaxel versus docetaxel with prednisone in taxane-naïve patients with symptomatic CRPC408IIITrial 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 CRPC626IIITrial terminated early based on futility analysis showing <30% chance of meeting primary endpoint (improved OS)[24]