IRCT20211206053304N2招募中1 期
The preliminary evaluation of therapeutic efficacy of 225Ac-PSMA-617 in patients of metastatic castrate resistant prostate cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- no limit 至 no limit(—)
- 性别
- Male
入选标准
- •Castration-resistant metastatic adenocarcinoma of the prostate should be confirmed by histopathology tests at the time of initial diagnosis
- •If a patient is in the metastatic stage of prostate cancer mCRPC and has cancerous lesions in distant areas, the primary site of the disease is present.
- •Cancerous lesions in imaging studies with 68Ga-PSMA-11 or 99mTc-PSMA-11 may demonstrate a higher uptake of the radiopharmaceutical than the uptake in normal liver tissue over the course of 4 weeks before treatment.
- •The patient may have previously received second-generation androgen deprivation therapies (Enzalutamide, Abiraterone), or it may not have been possible for the patient to receive them.
- •The patient may have received taxane-based treatments, or it may not have been appropriate to treat them with taxanes.
- •The patient has been treated with the beta-emitting radiopharmaceutical 177Lu-PSMA-617.
- •Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2.
- •Patients' GFR should be above 30
排除标准
- •Low bone marrow function :Hemoglobin concentration of g/dL,platelet count of <??? × ???/L, orwhite blood cell count of <?.? × ???/L), ANS<?.?×???/<brLow Kidney function: glomerular filtration rate of less than 30 mL/min/1.73 m? of body surface area;Serum/plasma creatinine?1.5×ULN or creatinin clearance<50 ml/min based on cockcroft-Gault formula
- •Low Liver function is defined(Albumin less than 2.5 g/dL, Billirubin?3×ULN ? ?? ?Alanine aminotransferase (ALT) or aspartate aminotransferase (SAT)?3.?×ULN .
- •Patients who do not have cancer lesions that absorb radioactivity in PET or SPECT imaging
- •Patients whose histology from the sampled tissue indicates sarcomatous/spindle cell/small cell differentiation.
- •Untreated patients with kidney obstruction
- •Patients with active secondary malignancy
- •Patients with Chronic or acute glomerulonephritis
- •Patients who have received chemotherapy, wide-field radiotherapy, and radiopharmaceuticals in the last 8 weeks are excluded from the study.
研究者
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