Anatomical Endoscopic Enucleation of the Prostate for Treatment of Bladder Outlet Obstruction in Patients With Low-risk Prostate Cancer on Surveillance Protocol, Prospective Assessment of Functional and Oncological Outcome
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- PSA progression
研究概览
简要总结
We will compare oncological and functional outcomes of anatomical endoscopic enucleation of the prostate (AEEP) versus continued medical treatment in low-risk prostate cancer patients for whom an active surveillance protocol was selected.
详细描述
Prostate cancer is the most common cancer in men; in 2018 1,276,106 new cases of prostate cancer were reported worldwide (1).
The diagnosis of prostate cancer is based on the microscopic evaluation of prostate tissue obtained via needle biopsy.
The International Society of Urological Pathology (ISUP) Consensus system assigns new Grade Groups from 1 to 5, derived from the Gleason score (2).
Clinicians have stratified the diagnosis into low, intermediate, and high-risk disease based on the sum of Gleason patterns, prostate specific antigen (PSA) level, and clinical stage (3).
Recently The National Comprehensive Cancer Network risk stratification uses a 5-tier system by adding very low- and very high- as a subdivision of the low- and high-risk groups (4).
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Life expectancy >/= 10 years
- •Low risk prostate cancer with minor institutional amendment of EAU guidelines:
- •PSA < 10 ng/ml or up to 20 ng/ml if PSA density is more than 15%
- •Stage T1, T2a.
- •Gleason score <7 (ISUP grade 1)
- •Bladder outlet obstruction:
- •IPSS > 9
- •Peak flow rate (Qmax < 15)
- •Imperative indication for BOO surgery
- •Exclusion criteria:
- •Patients who are not willing
- •Patients with bladder dysfunction (cystopathy) or other infravesical cause of obstruction other than prostate
排除标准
- 未提供
结局指标
主要结局
PSA progression
时间窗: one year
changes of PSA level from baseline to one year follow up following active treatment
radiological progression
时间窗: one year
cancer progression as depicted by multiparametric MRI
次要结局
- relief of bladder outlet obstruction(one year)
- relief of lower urinary tract symptoms(one year)
- 2 years progression free survival(2 years)
- 5 years progression free survival(5 years)
研究者
Ahmed Elshal
A. Professor of Urology
Mansoura University