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临床试验/NCT05995236
NCT05995236终止不适用

Prostate-Specific Membrane Antigen (PSMA) Radionuclide Therapy for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Methodist Health System2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年8月3日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
35
试验地点
2
主要终点
collect clinical data related to treatment of PSMA-positive metastatic castration-resistant prostate cancer

研究概览

简要总结

This study is a single-center registry study collecting clinical data regarding the treatment of PSMA-positive metastatic castration-resistant prostate cancer treated with PSMA radionuclide therapy per the treating physician's discretion. Clinical data from candidates for or who undergo the PSMA procedure at Methodist Dallas Medical Center from August 2022 to August 2027 will be collected after discharge and patients will undergo clinical follow-up per the treating physician's discretion.

详细描述

This study is a single-center registry study collecting clinical data regarding the treatment of PSMA-positive metastatic castration-resistant prostate cancer treated with PSMA radionuclide therapy per the treating physician's discretion. Clinical data from candidates for or who undergo the PSMA procedure at Methodist Dallas Medical Center from August 2022 to August 2027 will be collected after discharge and patients will undergo clinical follow-up per the treating physician's discretion.

Participants will be followed for two years following the first PSMA procedure. During these visits, participants will also be asked to report any change in their medications. Participants will not need to visit the study doctor more often than their usual treatment unless they have other medical needs. However, if participants experience any significant change in their medical condition they may be asked to have additional tests such as computed tomography (CT) scans, blood tests, etc.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 1. >18 years of age
  • 2. Diagnosed with PSMA-positive metastatic castration-resistant prostate cancer and - has consented to undergo PSMA nuclear therapy per the treating physician. Specifically:
  • Metastatic or Locally Advanced AND Inoperable
  • Clear disease progression on PSMA-PET/CT
  • PSMA-PET/CT scan positive disease within 6 weeks
  • Hemoglobin: >8 g/dL
  • White blood cell count: >2K cells/µL
  • Platelet (Thrombocyte) count: >75 x 109/L
  • No prior therapy with Radium-223 Dichloride

排除标准

  • Patients who do not meet the Inclusion Criteria laid out in section 4.2 will be excluded from the study.

结局指标

主要结局

collect clinical data related to treatment of PSMA-positive metastatic castration-resistant prostate cancer

时间窗: Clinical data from candidates for or who undergo the PSMA procedure at Methodist Dallas Medical Center from August 2022 to August 2027 will be collected after discharge and patients will undergo clinical follow-up per the treating physician's discretion

To collect clinical data related to patient characteristics, treatment responses and survival outcomes related to the treatment of PSMA-positive metastatic castration-resistant prostate cancer treated with PSMA radionuclide therapy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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