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临床试验/NL-OMON54136
NL-OMON54136招募中2 期

Magnetic resonance imaging-guided focal laser ablation of prostate cancer - MRI-guided focal laser ablation

Radboud Universitair Medisch Centrum0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
入组人数
15

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
18 至 99(—)

入选标准

  • MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted
  • imaging); • maximum MRI visible lesion size is <= 20 mm large axis; • age 45 to
  • 76 years old; • life expectancy at inclusion of more 10 years; • diagnosis of
  • prostate cancer confirmed by targeted biopsy; • criteria of low and
  • intermediate risk of progression and eligibility for focal therapy; o clinical
  • stage of maximum T2c o maximum biopsy Gleason score of 4 + 3 on targeted
  • biopsies o serum prostate specific antigen < 15 ng/ml • patient accepting to be
  • included in an active surveillance protocol at the end of the study, in
  • accordance with the recommendations of good practice.

排除标准

  • History of prostate surgery; • history of radiation therapy or pelvic trauma;
  • history of proved acute or chronic prostatitis; • history of tumor in the
  • preceding 5 years (excluded: non-metastatic basal cell skin cancer); • severe
  • urinary symptoms associated with benign hyperplasia of the prostate, and
  • defined by an IPSS score > 18; • tumor with extra-capsular extension or
  • invasion of the seminal vesicles; • patients with >2 lesions; • impossibility
  • to obtain a valid informed consent; • patients unable to undergo MR imaging,
  • including those with contra-indications; • contra-indications to MR guided
  • focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal
  • resection); • metallic hip implant or any other metallic implant or device that
  • distorts local magnetic field and compromises the quality of MR imaging; •
  • patients with evidence for nodal or metastatic disease; • patients with an
  • estimated Glomerular Filtration Ratio (eGFR) < 40 mL/min/1.73 m2.

研究者

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