Treatment With Sandostatin in Patients With Castrate Resistance Prostate Cancer Showing Uptake of 68Ga-DOTATET
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 主要终点
- Clinical response
研究概览
简要总结
Purpose: Castrate resistance prostate cancer (CRPC) often shows histological evidence of neuroendocrine differentiation (NED). Recently the investigators initiated a research project investigating the uptake of the radiotracer 68Ga-DOTATET (a marker of neuroendocrine tumors-NET) in PET/CT in patients with CRPC. In 4/8 patients studied thus far, uptake of the tracer in bone metastases was found. It has been shown that monthly injections of Somatostatin lengthen overall survival in patients with NET. The purpose of the current project is to examine the ability of Somatostatin to stabilize or possibly reverse metastases in patients with CRPC that express high level of somatostatin receptors in 68Ga-DOTATET PET/CT.
Materials and Methods: 30 patients with CRPC will be studied with 68Ga-DOTATET PET/CT. Patients showing uptake of the radiotracer 68Ga-DOTATET in at two least to metastases will be considered eligible for the study. These patients will be evaluated biochemically and clinically and will be treated with monthly injections of Sandoatatin LAR - 30mg. Clinical, biochemical and imaging studies (68Ga-DOTATET PET/CT) will be repeated after 4 and 12 months of treatment. Responding patients (stabilization or decrease in the number and SUV of metastases) will be subjected to continued therapy until progression.
详细描述
Introduction: Neuroendocrine tumors (NET) present receptors to somatostatin. This feature is utilized therapeutically in patients with metastatic NET. Monthly injection of Somatostatin was shown to lengthen overall survival (compared to placebo) in these patients. From histological studies it is known that advanced prostate cancer often shows neuroendocrine differentiation (NED). This is considered one of the mechanisms of "escape" of tumor cells from androgen deprivation therapy. Recently the investigatros initiated a research project investigating the uptake of the radiotracer 68Ga-DOTATET (a marker of neuroendocrine tumors-NET) in PET/CT in patients with castrate resistance prostate cancer. In 4/8 patients studied thus far, uptake of the tracer in bone metastases was found.
Purpose: The purpose of the current project is to examine the ability of LAR Somatostatin to stabilize or possibly reverse metastases in patients with castrate resistance prostate cancer that express high level of somatostatin receptors.
The aims of the study are:
- To detect biochemical response (PSA and chromogranin A)
- To detect PET response (in repeated PET/CT, 68Ga-DOTATET).
- To detect clinical response (QOL 30 questioner).
- To detect adverse response.
Materials and Methods:
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven prostate cancer.
- •Hormonal treatment (either surgical orchiectomy or medical castration with LHRH agonist or antagonist).
- •Proven castration levels (serum Testosterone< 50 ng/dl)
- •Radiological evidence of metastatic disease.
- •Uptake of the radiotracer 68Ga-DOTATET in at two least to metastases.
排除标准
- •Participation in another trial.
研究组 & 干预措施
Treatment arm
Monthly injections of Somatostatin (Sandoatatin LAR - 30mg)
干预措施: Somatostatin (Drug)
结局指标
主要结局
Clinical response
时间窗: 4 months
QOL 30 questioner
次要结局
- Biochemical response(4 months)
- Imaging response(4 months)
研究者
Ofer Gofrit
Prof. Ofer N. Gofrit, MD, PhD
Hadassah Medical Organization