PSA-3A VACCINATION

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。我们提出了一项临床试验，将肽PSA: 154-163(155L)（氨基酸序列VLSNDVCAQV代表成熟分泌PSA序列的154-163（155L）残基，编号不含24个氨基酸先导序列）作为一种疫苗接种策略，用于根治性前列腺切除术后血清PSA可检测和升高的HLA-A2患者的前列腺癌治疗。该试验将是单剂量水平的II期试点试验，每隔一周皮下注射1 mg PSA: 154-163(155L)，并用佐剂（Montanide¿ISA-51）乳化，x 4，然后每4周皮下注射x 3。主要结果将是确定免疫实验室终点，次要结果将是确定毒性和对血清PSA的影响。该试验分为两阶段设计，第一阶段共有18名患者。在中期分析后，如果PSA: 154-163（155L）肽仍然有希望，另外14名患者将接受治疗。

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.