Safety and Efficacy of Lu-177 PSMA Treatment in Metastatic Clear Cell Renal Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- toxicity analysis
研究概览
简要总结
Summary Renal Cell Carcinoma (RCC) consists of 2% of all malignencies. RCCs are generally divided to histopathological subtypes as clear cell and non-clear cell variants. Clear cell variant responsible for the 75-80% of all RCCs. It is reported that 20-30% of RCCs are metastatic at the diagnosis and 5 years survival is approximately is 10-20% in this group of patients. Moreover, 60% of patients who are not metastatic at the diagnosis, develop metastates within 2-3 years. 2nd and 3th line effective treatment option in metastatic RCCs patients has been a subject of interest.
PSMA (protatate specific membrane antigen) with the other name glutamate carboxypeptidase, is a transmembrane protein and overexpresses in prostate adenocarcinomas and neoangiogenesis spots of endothelium of other several tumor types. It infronts as a target for theranostic consept for mainly prostate cancer in nuclear medicine. As a radionuclide treatment option, Lu-177 PSMA treatment is proved as safe and effective treatment option in castration resistant prostata cancer patients. After its widely use in prostate cancer, it is reported that PSMA molecule can be used for imaging of RCC patients and PSMA uptake is higher than 18F-FDG. For this reason, Lu-177 PSMA treatment can be a systemic treatment option in RCC patients who have progress afer 1st cycle treatment. In this study we aimed to safety and efficacy of Lu-177 PSMA treatment in metastatic RCC patients as systemic radionuclide treatment option.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Progression after at least 2 lines of systemic therapy or existence of a contraindication to systemic therapies
- •At least 3 years of life expectancy
- •ECOG performance status ≤ 2
- •Ability to sign informed consent
排除标准
- •Not having received any systemic therapies
- •History of a secondary malignancy
- •ECOG performance status > 2
- •Any contraindication for radionuclide therapy (pregnancy, lactation, organ disfunction, metastatic lesions with a risk of compression
- •Previous history of any radionuclide therapies
- •Inability to sign informed consent
研究组 & 干预措施
Lu-PSMA treatment arm
Patients who will received Lu-177 PSMA treatment for metastatic RCC
干预措施: Lu-177 PSMA-617 (Drug)
结局指标
主要结局
toxicity analysis
时间窗: 1-36 months
Therapy associated toxicity will be evaluated according to CTCAE V5.0 criteria.
次要结局
- efficacy analysis(1-36 months)
研究者
Cigdem Soydal
Prof of Nuclear Medicine
Ankara University
