Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 490
- 试验地点
- 15
- 主要终点
- Biopsy pathological reclassification rate
研究概览
简要总结
In this study, the investigators aim to form a Brazilian national prospective active surveillance cohort of patients with low-risk prostate cancer in the public health system. The investigators aim to demonstrate data on the pathological reclassification rate, treatment-free survival, among others. This cohort aim to evaluate and validate the active surveillance strategy in Brazil.
详细描述
Prostate cancer is the most common malignancy in men in Brazil. It is estimated that about 80% of patients diagnosed with prostate cancer have localized disease, and many of these cases have low-risk cancer.
Active surveillance(AS) is a treatment strategy mainly for low risk prostate cancer to avoid radical treatment through periodic assessments (PSA, digital rectal exam and Prostatic Biopsies). During this follow-up, the patient will be treated only when necessary and with curative intent. Several series of institutional cohorts with long-term follow-up have demonstrated that the AS strategy in selected patients is a safe alternative to immediate treatment, with comparable survival.
The active surveillance strategy has never been evaluated in the Brazilian population. The main outcomes from AS derive from international cohorts. The Brazilian population is extremely diverse, so validation in this cohort is relevant. The current study aim to form a national multicentric prospective cohort of patients with low-risk prostate cancer following an AS protocol in the the public health system to evaluate and validate this strategy in Brazil.
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 78 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnosis of prostate adenocarcinoma;
- •Prostate biopsy with at least 12 cores;
- •PSA less than or equal to 10 ng/ml and clinical stage cT1/cT2a;
- •Gleason score below or equal to 6 (3+3);
- •Prostate multi parametric MRI performed or planned
- •Availability of pathological samples
排除标准
- •Clinical contraindication to prostatectomy and/or radiotherapy procedures;
- •Life expectancy below 10 years, according to the Charlson Comorbidity Index (ICC);
- •Previous treatment with hormone blockade or radical therapies.
- •Intraductal or cribriform histology on biopsy
研究组 & 干预措施
Active surveillance
This is a multicentric active surveillance prospective cohort study. The eligibility criteria defined are: low-risk prostate adenocarcinoma (clinical stage of cT1-T2a / Group Grade 1 (Gleason score less or equal to 6) / PSA less or equal to 10 ng/ml), transrectal prostate biopsy with at least 12 cores, estimated life expectancy over 10 years, clinical conditions for definitive treatment, multiparametric prostate MRI performed or planned.
干预措施: Active surveillance (Other)
结局指标
主要结局
Biopsy pathological reclassification rate
时间窗: 12-month analysis
Gleason score above 6 (min: 6 - max: 10) in prostate biopsy
次要结局
- EPIC evaluation(12-month and 24-month analysis)
- Cancer-Specific Mortality Rate(12-month and 24-month analysis)
- Metastasis-free survival rate(12-month and 24-month analysis)
- Quality of life evaluation(12-month and 24-month analysis)
- Biochemical recurrence rate after radical therapy(12-month and 24-month analysis)
- Treatment-Free Survival rate(12-month and 24-month analysis)
- Overall survival rate(12-month and 24-month analysis)
- Anxiety evaluation(12-month and 24-month analysis)