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

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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. 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.