0430 GCC

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. We propose a clinical trial of the peptide PSA: 154-163(155L) (amino acid sequence VLSNDVCAQV representing residues 154-163 (155L) of mature secreted PSA sequence numbered without the 24 amino acid leader sequence) as a vaccination strategy for the treatment of prostate cancer in HLA-A2 patients with detectable and rising serum PSA after radical prostatectomy. The trial will be a single dose-level, Phase II pilot trial of 1 mg of PSA: 154-163(155L) emulsified with adjuvant (Montanide¿ ISA-51) given subcutaneously at 2 sites every other week x 4, then every 4th week x 3. The primary outcome will be determination of immunologic laboratory endpoints, secondary outcomes will be determination of toxicity and effect on serum PSA. The trial is a two-stage design with 18 patients enrolled in the first stage. After an interim analysis an additional 14 patients will be treated if the peptide PSA: 154-163(155L) remains promising.