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
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