跳至主要内容
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

相似试验

tility of 18F-fluorocholine positron emission... | 临床试验