Pilot Study of PSMA-TRT Re-treatment Utilizing 225Ac-J591
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in the proportion of subjects in assessing safety of 225Ac-J591 in those previously treated with PSMA-TRT.
研究概览
简要总结
The purpose of this study is to find out if re-treatment with 225Ac-J591 can be given without severe side effects.
详细描述
This is an open-label, pilot study designed to determine the safety of PSMA-TRT re-treatment with 225Ac-J591, which will be given in a single dose on D1, in men with progressive mCRPC. If the patient responds and tolerates this dose, another may be given upon progression, provided at least 12 weeks after the initial dose.
This research study is being done because the standard treatments for prostate cancer that has spread beyond the prostate gland are intended to minimize the adverse effects of the disease and make men live longer. These treatments, however, are not curative so additional treatments are needed. Prostate-specific membrane antigen (PSMA) is a protein that is on the surface of most prostate cancer cells. It is absent from most other normal places in the body, but is present to some degree in the kidney, small intestine, salivary glands, and brain. J591 is a monoclonal antibody (an engineered protein) which recognizes PSMA. Actinium-225 (225Ac) is a small radioactive particle that emits alpha-particles (damaging/ionizing radiation). 225Ac-J591 is the combination compound that has the radioactive particle linked to J591. It is designed so that J591 will recognize PSMA and drags the radioactive particle 225Ac with it wherever it goes. This drug used currently is not FDA approved for any indication and is considered experimental.
In the first part of the study, a small group of subjects will receive a dose of 225Ac-J591 based upon a prior study. If that dose does not lead to severe side effects in many subjects, an additional small group will be treated. If the initial dose leads to too many severe side effects, another group will receive a lower dose. If it is determined by a physician that a subject's tumor has responded favorably to treatment, did not experience severe side effects and subject in agreement, then the subject will be allowed to receive one additional dose of the study drug 225Ac-J591, provided that at least 3 months have passed since the initial dose. For subjects receiving re-treatment, they will also participate in the same study procedures and followed for treatment including short-term and long-term follow up.
All treatment visits and all visits involving investigational PSMA PET imaging are required to be performed at the Weill Cornell Medicine - NewYork Presbyterian site located in the upper east side of Manhattan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Heavily Exposed
干预措施: 225Ac-J591 (Drug)
Moderately Exposed
干预措施: 225Ac-J591 (Drug)
结局指标
主要结局
Change in the proportion of subjects in assessing safety of 225Ac-J591 in those previously treated with PSMA-TRT.
时间窗: Will be collected at the time of visit 1 through end of study or 100 months
Proportion of subjects with dose-limiting toxicity (DLT) from treatment cycle 1 to the end of the safety evaluation period at the end of the study. Acceptable safety is determined if no more than 2 (33%) of the subjects in a cohort experience DLT.
次要结局
- Change in the number of subject with Prostate Specific Antigen (PSA) decline following 225Ac-J591 administration(Will be collected at the time of visit 1 through end of study or 100 months)
- Change in adverse event rate response(Will be collected at the time of visit 1 through end of study or 100 months)
- Change in the number of subjects with dose limiting toxicity (DLT)(Will be collected at the time of visit 1 through end of study or 100 months)
- Change in radiographic response rate(Will be collected at the time of visit 1 through end of study or 100 months)
- Change in circulating tumor cells (CTC) response(Will be collected at the time of visit 1 through end of study or 100 months)
- Change in progression-free survival following re-treatment doses of 225Ac-J591(Will be collected at the time of visit 1 through end of study or 100 months)
- Change in Overall Survival Following re-Treatment Doses of 225Ac-J591(Survival will be collected at the time of visit 1 through end of study or 100 months)