Canary Prostate Active Surveillance Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 22
研究概览
简要总结
The Prostate Active Surveillance Study (PASS) is a research study for men who have chosen active surveillance as a management plan for their prostate cancer. Active surveillance is defined as close monitoring of prostate cancer with the offer of treatment if there are changes in test results. This study seeks to discover markers that will identify cancers that are more aggressive from those tumors that grow slowly.
详细描述
This is a multi-center, prospective active surveillance study with selective intervention in patients with previously untreated, clinically localized prostate cancer at diagnosis. Candidates are assessed based on an extended core biopsy, serum PSA (including PSA kinetics, if available), digital rectal examination (DRE), and assessment of cancer grade and extent.
Active surveillance is defined as serial PSA measurements and prostate examination with routine prostate biopsy and therapeutic intervention considered at the time one or more of the following:
- Grade or volume progression
- Clinical progression
The objectives of the study are as follows:
Primary Objective
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate from a prostate biopsy.
- •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).
- •ECOG Performance Status 0 or
- •Patient has elected Active Surveillance as preferred management plan for prostate cancer.
- •Patient consent has been obtained according to local Institutional Review Board for acquisition of research specimens.
- •Patient is accessible and compliant for follow-up.
- •Prostate cancer diagnosis cannot be more than 3 years prior to baseline visit date.
- •No more than two prostate biopsies including the initial biopsy in which cancer was diagnosed.
- •If cancer diagnosis is more than one year before enrollment, there must be two prostate biopsies including the initial biopsy in which cancer was diagnosed and a subsequent biopsy. The subsequent biopsy may occur on the same day as the baseline visit.
- •Biopsies must have at least 10 cores.
排除标准
- •Unwillingness or inability to undergo serial prostate biopsy.
- •History of other malignancies, except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer (Ta) or other solid tumors curatively treated with no evidence of disease for > 5 years.
研究者
Daniel Lin
Professor, Urology
University of Washington