START (Active Surveillance or Radical Treatment for Newly Diagnosed Patients With a Localized, Low Risk, Prostate Cancer): an Epidemiological Study of the Oncology Network of Piemonte and Valle d'Aosta (Italy)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 850
- 试验地点
- 1
- 主要终点
- Treatment-Free Survival (TFS)
研究概览
简要总结
The purpose of the START project is to evaluate the acceptability, the safety and the cost-effectiveness of a population based program of active surveillance for patients newly diagnosed with a localized, low risk, prostate cancer.
详细描述
Comparative effectiveness research project. All newly diagnosed prostate cancer patients fulfilling the low risk definition, resident in Piedmont or in Valle D'Aosta regions, will be invited to participate. All enrolled patients will receive full and clear information about their prognosis together with a balanced synthesis of the benefits and risks of the available treatments (active surveillance or radical treatments).
Specific objectives are:
- To estimate, at a population level, the proportion of newly diagnosed prostate cancer at low risk, eligible for active surveillance, the proportion of those accepting to be enrolled in a cohort of active surveillance and the risk of abandoning the program during follow-up.
- To compare the patients' and physicians' characteristics of those accepting to be managed within the active surveillance program with those preferring a radical treatment (either surgery or radiotherapy).
- To compare, at a population level, the clinical outcomes, quality of life and costs associated to different treatment choices.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed low risk prostate cancer patients, defined according to the presence of all the following criteria:
- •diagnosis of adenocarcinoma of the prostate
- •prostate cancer clinical stage T1c o T2a
- •PSA <=10ng/ml at diagnosis
- •adequate biopsy sampling according to prostate volume
- •maximum of two positive cores for random sampling and of maximum two lesions for target biopsies (even if the number of positive samples if >2)
- •Gleason grade 3+3 ( in patients age>70 Gleason 3+4)
- •Residence in Piemonte or Valle D'Aosta regions;
- •Patients suitable for radical treatment (surgery or radiotherapy);
- •Age at diagnosis <= 75 years or >75 years if fragility assessment (measured with the G8 score)> = 14;
- •Patients suitability for expressing a valid consent to participate in the study.
排除标准
- •Patients previously treated for prostate cancer.
- •Patients not willing to undergo radical treatments (surgery or radiotherapy).
结局指标
主要结局
Treatment-Free Survival (TFS)
时间窗: Up to 24 months
Proportion of patients in active surveillance program alive and not undergoing active treatment for prostate cancer.
次要结局
- Cost-effectiveness(Up to 24 months)
- Quality of Life(Up to 24 months)