PHASE II TRIAL OF 177LU-J591 IN METASTATIC, ANDROGEN-INDEPENDENT PROSTATE CANCER

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 研究人员已经证明，针对前列腺特异性膜抗原（PSMA）的mAB J591成功靶向几乎所有患者的转移性前列腺癌部位。此外，他们还定义了177 Lu-J591的MTD。 他们现在试图研究这种药剂在这个剂量下的初步疗效。 主要目的是定义PSA缓解率和可测量的疾病缓解率。 次要目的是：（1）定义PSA应答的持续时间，（2）定义可测量疾病应答的持续时间，（3）定义人抗J591抗体（HAHA）应答的发生率，（4）比较血液学毒性相对于骨髓受累（骨扫描指数），（5）评估治疗后患者的存活率，和（6）确认177 Lu-J591靶向已知的肿瘤部位。

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. The investigators have demonstrated that mAB J591, directed to prostate-specific membrane antigen (PSMA), sucessfully targets metastatic prostate cancer sites in virtually all patients. Furthermore, they have defined the MTD of 177Lu-J591. They now seek to study the preliminary efficacy of this agent at this dose. Primary Objectives are to define the PSA response rate, and the measurable disease response rate. Secondary Objectives are to: (1) define the duration of PSA response, (2) define the duration of measurable disease response, (3) define the incidence of human anti-J591 antibody (HAHA) response, (4) compare hematological toxicity relative to bone marrow involvment (bone scan index), (5) assess the survival rate of patients following treatment, and (6) confirm the targeting of 177Lu-J591 to known tumor sites.