NCT00676286已完成1 期
Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Primary objective to determine if we can accrue patients to this study in a timely manner.
研究概览
简要总结
This study will use high field MRI (3 Tesla), PET and biomarker to follow prostate cancers and determine if these tests can detect cancers that become aggressive.
详细描述
This study may lead to the identification of additional investigations that can monitor for signs of disease progression in active surveillance protocols. This can directly benefit patients by providing them with greater confidence that their disease is being accurately monitored. In addition, this study may be beneficial to the general management of prostate cancers by adding to our knowledge of these investigations characterizing prostate cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Histologically proven adenocarcinoma of the prostate
- •Registration must occur within 16 weeks of last biopsy
- •History and physical exam (including DRE) within 8 weeks prior to registration
- •Patients must have indolent prostate cancer including all of the following: Low risk prostate cancer, less or equal to 50 % of core biopsies involved with disease, and less or equal to three biopsies involved with disease
- •Patients must have a minimum of six biopsies (sextant) at registration
- •PSA test within 8 weeks registration
- •Creatinine level below 100 umol/L within 8 weeks of registration
- •Patients must have no contraindications to MRI scans
- •No history of previous malignancies except non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy
- •Patients must be reliable for follow up
排除标准
- •Patient does not have histologically-proven adenocarcinoma of the prostate
- •Last biopsy greater than 16 weeks prior to registration
- •History and physical exam (including DRE) greater that 8 weeks prior to registration
- •Patient does not have indolent disease
- •Patient has less than six sextant biopsies at registration
- •PSA test done greater than 8 weeks from registration
- •Creatinine level greater than 100 umol/L within 8 weeks of registration
- •Contraindications to MRI scans
- •History of previous malignancies other than non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy
- •Patients that are not reliable for follow up
结局指标
主要结局
Primary objective to determine if we can accrue patients to this study in a timely manner.
时间窗: 2 years
次要结局
- Incidence of patients developing progressive prostate cancer warranting definitive treatment in an active surveillance protocol(patients followe for 5 years from baseline)
- The natural history of prostate cancer with these investigations(patients followed for 5 years from baseline)
- Optimal imaging parameters to characterize prostate cancers(patients followed for 5 years from baseline)
- The sensitivity and specificity of these investigation in detecting prostate cancer(patients followed for 5 years from baseline)
- feasibility of detecting gene arrangements in prostate biopsies(patients followed for 5 years from baseline)
- Patient compliance(Patients followed for 5 years from baseline)
- The sensitivity and specificity of these investigations in differentiating indolent prostate cancer from aggressive disease(patients followed for 5 years from baseline)
- The sensitivity and specificity of these investigations in detecting high grade disease, extracapsular disease and extraprostatic disease and disease progression(patients followed for 5 years from baseline)
研究者
研究点 (2)
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