Safety and Dosimetry of 177Lu-PSMA-EB-01 in Patients With Metastatic Castration-resistant Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Dosimetry of normal organs and tumors
研究概览
简要总结
This is a pilot study to assess the safety and measure image-based absorbed dose of 177Lu-PSMA-EB-01, a new PSMA-specific radiopharmaceutical, in patients with metastatic castration resistant prostate cancer (mCRPC) who will undergo radioligand therapy (RLT). All patients underwent 68Ga-PSMA and 18F-FDG PET/CT for selection and were randomly divided into three groups of 3 people each.The three groups received an approximately 1.11 GBq (30mCi), 1.85 GBq (50 mCi) and 2.59 GBq (70mCi) of 177Lu-PSMA-EB-01 up to 2 cycles, respectively.
详细描述
Prostate cancer is the most frequent malignant tumor in men worldwide. Prostate-specific membrane antigen (PSMA), is a surface molecule specifically expressed by prostate tumors which was shown to be a valid target for radiotherapy. 177Lu-PSMA-617, a urea-based compound, provide an effective target for the treatment of metastatic castration-resistant prostate cancer. However, a major problem in the therapeutic use of 177Lu-PSMA-617 has been its short half-life and fast rate of clearance. The investigators designed and synthesized a new radiopharmaceutical, named 177Lu-PSMA-EB-01. EB（Evans Blue）can bind to albumin to slow down its plasma clearance rate, thereby increasing tumor accumulation and reducing the total dosage of Lu-177. Hence, EB-PSMA-01 may be an option for consideration due to limited supply of Lu-177, by which more patients may be benefited by this version of 177Lu-EB-PSMA-01. This study was designed to investigate the safety, dosimetry and preliminary effects of 177Lu-EB-PSMA-01 in patients with metastatic castration resistant prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •progressive metastatic castration-resistant prostate cancer
- •tumors with high PSMA expression confirmed on 68Ga-PSMA PET/CT
排除标准
- •a serum creatinine level of more than 150 μmol per liter
- •a hemoglobin level of less than 10.0 g/dl
- •a white-cell count of less than 4.0× 109/L
- •a platelet count of less than 100 × 109/L
- •a total bilirubin level of more than 3 times the upper limit of the normal range
- •a serum albumin level of more than 3.0 g per deciliter
- •cardiac insufficiency
研究组 & 干预措施
1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01
All patients were intravenous injected with single dose 1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours post-injection.
干预措施: 1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01 (Drug)
1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01
All patients were intravenous injected with single dose 1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours post-injection.
干预措施: 1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01 (Drug)
2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01
All patients were intravenous injected with single dose 2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours post-injection.
干预措施: 2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01 (Drug)
结局指标
主要结局
Dosimetry of normal organs and tumors
时间窗: through study completion, an average of 4 weeks
The semiquantitative dosimetry will be performed based on SPECT/CT acquisitions after the first administration of 177Lu-PSMA-EB-01. The dose delivered to normal organs and tumors will be recorded.
Hematologic adverse events collection
时间窗: through study completion, an average of 6 months
Hematologic status were performed before and every 2 weeks after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0
Hepatic and renal toxic events collection
时间窗: through study completion, an average of 6 months
Liver function, and renal function were performed before and 4 weeks after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
次要结局
- PSA Response(through study completion, an average of 6 months)