NCT01354171Unknown3 期
Active Surveillance Magnetic Resonance Imaging Study
Canadian Urology Research Consortium6 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2011年11月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 250
- 试验地点
- 6
- 主要终点
- To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (3+4) or higher
研究概览
简要总结
This is a multi-centre, prospective, randomized phase III trial to determine if multi-parametric Magnetic Resonance Imaging (MRI) can improve selection of patients eligible for active surveillance through better detection of clinically significant cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •histological confirmation of adenocarcinoma of the prostate
- •candidate for active surveillance (favourable risk prostate cancer) as defined by the following:
- •Clinical stage T1b, T1c, T2a or T2b at the time of diagnosis
- •Clinical (diagnostic biopsy) Gleason sum < 6
- •PSA < 10.0 ng/ml (ug/L)
排除标准
- •Previous treatment for prostate cancer including surgery (excluding biopsy), radiation therapy, hormonal therapy (e.g. megestrol, medroxyprogesterone, cyproterone, DES), glucocorticoids (except inhaled or topical), LHRH analogues (e.g. Leuprolide, goserelin), ketoconazole, non-steroidal antiandrogens (e.g. bicalutamide, flutamide) and/or any 5α-reductase inhibitors within 3 months of randomization
- •Planned anti-androgen therapy
- •Inability to undergo TRUS biopsy
- •Inability to undergo multi-parametric MRI
结局指标
主要结局
To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (3+4) or higher
时间窗: one year
次要结局
- To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (4 + 3) or higher(one year)
研究者
研究点 (6)
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