Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Percentage of enrolled subjects who remain compliant free until disease progression.
研究概览
简要总结
The purpose of this research study is to monitor the feasibility and outcome of the Active Surveillance Program for men with low risk prostate cancer.
详细描述
The purpose of this observational study is to prospectively monitor the outcome associated with men who meet the eligibility criteria for low risk prostate cancer and elected to participate in the active surveillance program at The Center for Cancer Prevention and Treatment at St. Joseph Hospital. We hope to demonstrate that men who are compliant with a closely monitored active surveillance program for low risk prostate cancer will achieve favorable outcomes by: 1) avoiding the side effects of definitive therapy that may not be necessary; 2) retaining quality of life (QOL) and normal activities; 3) avoiding unnecessary treatment; and 4) decreased health care costs. In addition, we will monitor the possible adverse outcomes that may be associated with the active surveillance program including suboptimal response and/or greater side effects due to delayed initiation of therapy; psychological impact on the patients and caregivers due to anxiety of living with an untreated cancer and/or the requirement for frequent medical examination and periodic prostate biopsies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Histological documented adenocarcinoma of the prostate either newly diagnosed or previously diagnosed. Subjects who are diagnosed more than 3 months prior to time of enrollment in the active surveillance program must have biopsy repeated.
- •PSA < 10 ng/ml within 1 month of program enrollment
- •Clinical stage less than or equal to T2a
- •Biopsy sampling with at least 10-12 cores
- •Gleason score less than or equal to 3 + 3
- •No more than 2 cores involved
- •No core more than 50% involved
- •Eligible for definitive therapy
- •Able to provide informed consent
- •Able to complete a QOL questionnaire
- •Able to comply with the scheduled follow-up appointments
排除标准
- •See inclusion criteria for eligibility
结局指标
主要结局
Percentage of enrolled subjects who remain compliant free until disease progression.
时间窗: 10 years
This measurement will monitor the feasibility of the Active Surveillance Program for men with low risk prostate cancer
次要结局
- Percentage of enrolled subjects who require definitive therapy(10 years)
- Overall survival(10 years)
- Quality of Life as measured by patient survey.(10 Years)
- Cost/Benefit Analysis(10 Years)