Table 1.
Recent Frontline Randomized Trials of Vaccines for CRPC
| Institution (Trial) | Population | Standard Arm | Experimental Arm | Results |
| Multicenter (IMPACT or D9902B) | Asymptomatic metastatic chemonaïve CRPC | Placebo | Sipuleucel-T | Improved overall survival with vaccine |
| Multicenter (VITAL-1) | Asymptomatic metastatic chemonaïve CRPC | Docetaxel +prednisone | GVAX | Closed prior to completion for futility |
| Multicenter (VITAL-2) | Symptomatic metastatic chemonaïve CRPC | Docetaxel +prednisone | GVAX + docetaxel | Closed after interim analysis showed inferiority for vaccine arm |
| Multicenter phase II randomized trial | Asymptomatic metastatic chemonaïve CRPC | Placebo | Prostvac + GM-CSF | Improved survival with vaccine |
| ECOG (PARADIGM) | Nonmetastatic CRPC | GM-CSF | Prostvac + GM-CSF | Planned |
CRPC, castration-resistant prostate cancer; ECOG, European Cooperative Oncology Group; GM-CSF, granulocyte-macrophage colony-stimulating factor. GVAX is manufactured by BioSante Pharmaceuticals, Lincolnshire, IL..