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临床试验/NL-OMON27850
NL-OMON27850已完成不适用

Feasibility of MRI-guided focal salvage high-dose-rate brachytherapy for locally recurrent prostate cancer

niversity Medical Center Utrecht0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30

研究概览

简要总结

one

研究设计

研究类型
Interventional

入排标准

入选标准

  • Age >18 years;
  • -Biopsy proven local recurrence;
  • -Biopsy proven recurrence at least 2 years after primary radiotherapy treatment (low-dose-rate brachytherapy or external beam radiation therapy);
  • -Limited and non-aggressive tumor presentation at time of salvage (PSA at time of salvage <10);
  • -PSA doubling time more than 12 months;
  • -Acceptable toxicity of primary radiation treatment (IPSS<15);
  • -Tumour location technically feasible for brachytherapy;
  • -Tumour on MRI and PSMA/choline PET scan within anatomical prostate borders (no extracapsular growth or metastases);
  • -Karnofsky score >70;
  • -Written informed consent;
  • -Fit for anaesthesia.

排除标准

  • -Distant metastases;
  • -Severe toxicity from primary radiation treatment (IPSS>15);
  • -Patients who meet exclusion criteria for MRI following the protocol of the radiology department of the UMC Utrecht (see appendix);
  • -Anticoagulant administration continuously required, except for Ascal;
  • -Discongruence between prostate biopsies and contrast MR imaging;
  • -Prior prostate treatment(s) (like a recent TURP (<6 months before focal salvage HDR treatment), HIFU, cryosurgery), except for radiotherapy.

研究者

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