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临床试验/NL-OMON50549
NL-OMON50549招募中2 期

[18-F]-Fluordihydrotestosterone PET and [18F]-prostate specific membrane antigen in metastasized castrate resistant prostate cancer - Movember GAP2 project

Vrije Universiteit Medisch Centrum0 个研究点目标入组 36 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
2 期
状态
招募中
入组人数
36
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99（—）

入选标准

  • •1: Histologically or cytologically proven metastatic CRPC.
  • •2. Progressive disease based on any of the following:
  • •(a) a rise in PSA through 3 consecutive measurements
  • •(b) progressive disease by virtue of transaxial imaging based on RECIST 1.1
  • •(c) radionuclide bone scan showing at least two new metastatic lesions.
  • •3. Patients will have castrate levels of serum testosterone <= 50 ng/dL.
  • •4. Written informed consent, Substudy:
  • •1. Inclusion in the Movember GAP2 project
  • •2. Written informed consent
  • •3. Patients have to be able to remain supine for 70 minutes

排除标准

  • •1. Patients already on enzalutamide or other antiandrogens
  • •2. Contraindications for MRI, Sub-study
  • •1. Claustrophobia
  • •2. Multiple malignancies
  • •3. Hb < 6.0 mmol/L
  • •4. Renal insufficiency (GFR < 30 mL/min/1.73m2)
  • •5. Known hypersensitivity to Gadovist

研究者

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