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临床试验/IRCT20211206053304N2
IRCT20211206053304N2招募中1 期

The preliminary evaluation of therapeutic efficacy of 225Ac-PSMA-617 in patients of metastatic castrate resistant prostate cancer

Iran University of Medical Sciences0 个研究点目标入组 10 人开始时间: 待定最近更新:

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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