The UCLA ASCAP Project is an Observational, Longitudinal, and Open-ended Study Aimed at Establishing a Structured Program of Non-interventional Follow-up for Localized Prostate Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 462
- 试验地点
- 2
- 主要终点
- Discover and confirm clinical parameters that predict aggressive disease as defined by pre-specified histological, PSA, clinical criteria, or outcomes based on these variables.
研究概览
简要总结
Active Surveillance (A.S.) of prostate cancer (CaP) is the systematic monitoring of men with low-risk, localized lesions, with curative treatment of those whose tumors show substantial progression. A.S. is different from Watchful Waiting (W.W.), which is the palliative treatment of men with progressive prostate cancer.
详细描述
This protocol is not designed as a formal clinical trial, but rather an observational protocol; no treatments and no randomization are included. Longitudinally, specimens and clinical data will be collected to provide information on the following:
- Imaging studies of the prostate
- Rates of curative intervention
- Measures of tumor recurrence/progression
- Disease specific survival
- Overall survival
- Clinical data to track Quality of Life
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate.
- •Clinically localized prostate cancer: T1-2, NX or N0, MX or M
- •No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
- •Patient has elected Active Surveillance as preferred management plan for prostate cancer.
- •Patient consent has been obtained according to local Institutional Review Board .
- •Patient is accessible and compliant for follow-up.
排除标准
- •Unwillingness or inability to undergo serial prostate biopsy.
- •Overall life expectancy less than 2 years
- •Advanced prostate cancer
结局指标
主要结局
Discover and confirm clinical parameters that predict aggressive disease as defined by pre-specified histological, PSA, clinical criteria, or outcomes based on these variables.
时间窗: Interim data analysis will be made every year
次要结局
- Determine the clinical predictors of disease progression. Measure the recurrence-free, disease-specific, and overall survival of men on active surveillance for clinically localized prostate cancer. Determine factors that lead to active intervention(Interim data analysis will be done each year)