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临床试验/ACTRN12608000641392
ACTRN12608000641392招募中2 期

A randomised trial comparing 18F-fluorocholine positron emission tomography/computed tomography (FCH-PET/CT) with Conventional Imaging (computed tomography and whole-body bone scan) with respect to their first-line utility in the staging or restaging of patients with prostate cancer.

Peter MacCallum Cancer Centre0 个研究点目标入组 100 人开始时间: 2008年12月17日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Diagnosis
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
Male

入选标准

  • Biopsy-proven prostate cancer;
  • Age = 18 years;
  • Written informed consent has been provided.
  • Newly-diagnosed prostate cancer (Staging Population):
  • Patient has not undergone any form of treatment for his disease;
  • Non-low risk disease. He must have at least one of the following features: prostate specific antigen (PSA) = 10.0 ng/ml within 8 weeks prior to randomisation; Gleason score = 7; clinical stage = T2b.
  • Suspected recurrent prostate cancer (Restaging Population):
  • Patient has undergone local radical treatment;
  • Within the 8 weeks prior to randomisation, the PSA level must be = 0.5 ng/ml and rising (post-operatively) or a PSA level of 2 ng/mL or more above the nadir PSA level (post-radiotherapy).

排除标准

  • Participant has undergone, within 8 weeks prior randomisation, a diagnostic imaging(DI) procedure for the staging (N-staging or M-staging) or restaging of his prostate cancer;
  • A history of other active malignancy within the last 5 years, with exception of non-melanoma skin cancer;
  • Presently having androgen deprivation therapy started less than 6 months ago;
  • Where radical treatment of the patient would not be contemplated on the basis of limited expected lifespan due to comorbid conditions.

研究者

发起方
Peter MacCallum Cancer Centre

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