Abstract
3005 Background: Vaccine strategies represent a novel therapeutic approach for mCRPC. PSA-TRICOM is a pox viral-based vaccine that contains the transgene for PSA and 3 co-stimulatory molecules required for T-cell activation. The vaccine employs a prime/boost strategy; after an initial vaccinia-based vaccine, all subsequent vaccinations utilize a fowlpox-based vaccine. PSA-TRICOM was well tolerated in a phase I study. Methods: 32 chemotherapy naive patients (pts) with mCRPC were treated with PSA-TRICOM subcutaneously monthly with or without adjuvant GM-CSF in this phase II study with 4 cohorts. Pts were re-staged every 3 months (mos) with CT and bone scans. Elispot assay pre and post treatment was done to evaluate PSA-specific T cell response. An OS analysis has been performed on these pts; we also compared actual to predicted OS based on the Halabi Score (HS) and compared OS stratified according to T-cell responses. Results: On study median age=65.6 years, median Gleason Score=8 (range 6–10), median PSA=7...
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