Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of patients on active surveillance in group Epstein + and Epstein -
研究概览
简要总结
Active Surveillance manages selected men with prostate cancer expectantly with curative intent. This means men are carefully selected and subsequently actively observed in order to have the possibility to offer them curative treatment once the tumor seems to progress.
The goal of this study is to validate the treatment option Active Surveillance in men with localized, well differentiated prostate cancer, in order to limit the amount of overtreatment. A number of key points will be studied, such as the pathological findings in radical prostatectomy specimens, and the effect of expectancy on the quality of life.
详细描述
Objectives:
Primary
- To evaluate the equivalence of the time on active surveillance before an active treatment between group Epstein + and the expanded active surveillance group (Epstein -)
Secondary
- To evaluate the role of diffusion-weighted MRI (DW-MRI) in the initial diagnosis and the follow-up of patients under active surveillance
- To evaluate the role of BCAR-1 to predict the clinical outcome of localized prostate cancer
- To evaluate the proportion of patients who discontinued active surveillance
- To evaluate the mortality at 10, 15 and 20 years from the inclusion in the study
- To evaluate the time to radical treatment
- To evaluate the time to metastatic disease
- To evaluate patients quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Localized adenocarcinoma of the prostate with a Gleason score of 3+3 (group I patients) or 3+4 (group II patients)
- •Percentage of tumor biopsy invasion <50% and/or with a size of maximum 8 mm
- •With a number of positive tumor biopsies ≤3 (group I patients) or ≤ 5 (group II patients)
- •TNM stage T1-2a N0 M0 (group I patients); TNM stage T1-2c N0 M0 (group II patients)
- •PSA level at diagnosis < 10 ng/ml for group I patients; < 15 ng/ml for group II patients
- •Tumor volume negative (group I patients); positive (group II patients)
- •Absence of extra-capsular extension
- •Life expectancy > 10 years
- •Signed informed consent
- •Patient has elected active surveillance as preferred management plan for the prostate cancer
排除标准
- •Previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery or chemotherapy)
- •Patients with hypogonadism
研究组 & 干预措施
Epstein + (group I)
Epstein + (Group I) PSA <10 ng/ml; Gleason 3+3=6; Number of positive biopsies ≤3/12;
% of tumor biopsy invasion <50% or ≤3mm; mp MRI negative; c-rTNM T1-T2a N0 M0
干预措施: Active surveillance (Other)
Epstein - (group II)
Epstein - (Group II) PSA <15 ng/ml; Gleason score max 3+4; Number of positive biopsies ≤5/12
% of tumor biopsy invasion <50% and ≤8mm; mp MRI positive; T1-T2c N0 M0
干预措施: Active surveillance (Other)
结局指标
主要结局
Proportion of patients on active surveillance in group Epstein + and Epstein -
时间窗: 6 years
次要结局
- Percentage of patients who progressed to a metastatic stage at different time points in both groups(Every year for 6 years)
- Percentage of deceased patients 10, 15 and 20 years from the inclusion in the study in both groups(10, 15, 20 years)
- BCAR-1 test on biopsies(baseline, 12, 24 months and every 4 years)
- Tumor volume increased, extra-capsular extension or presence of adenopathy assessed on DW-MRI(baseline, 12, 24, 48 months and every two years.)
- Percentage of patients who discontinued active surveillance by categories (patient's will, clinical or histological criterion)(Every 6 months for 6 years)
- Quality of life assessment(Every 6 months for 6 years)
研究者
Prof. Patrice Jichlinski
Chief of Urology Department, University of Lausanne Hospitals
Centre Hospitalier Universitaire Vaudois