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临床试验/NCT02971085
NCT02971085招募中不适用

Seoul National University Prospectively Enrolled Registry for Prostate Cancer With Active Surveillance

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 410 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
410
试验地点
1
主要终点
Pathological reclassification

研究概览

简要总结

In this study, the investigators aim to establish the prostate cancer active surveillance prospective cohort in our institution, and finally investigate the 5 year rates of reclassification during active surveillance as the primary endpoint of the current study.

详细描述

Prostate cancer (PCa) remains one of the most commonly diagnosed malignancies in men worldwide. Early diagnosis and definitive therapy seem to improve oncological outcomes in men with high-risk disease, but significant concerns exist in terms of the overdiagnosis and overtreatment of patients with lower-risk tumors. In this context, active surveillance (AS) has recently emerged as a alternative treatment strategy in PCa patients with low risk cancers. However, published data are based on Western population with different protocol, and therefore; well-controlled data with well-organized and prospective cohort are urgently needed in Korean patients with low-risk PCa because Korean patients have significantly different tumor characteristics compared to Western patients. Here, the investigators have a plan to establish the Seoul National University Enrolled Registry for Prostate Cancer with Active Surveillance, and finally provide the concrete evidence for the clinical outcomes of active surveillance program as the primary therapeutic strategy for low-risk PCa in Korean men.

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
40 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Men < 80 years
  • Pathologically proven adenocarcinoma of the prostate by transrectal prostate biopsy ≥ 10 cores
  • Pre-Bx PSA ≤ 10ng/ml
  • PSA density < 0.15ng/ml/ml
  • Clinical stage T1-2a
  • Biopsy Gleason score ≤ 6
  • No. of positive cores ≤ 2
  • Maximum cancer involvement in any one core ≤ 20%.
  • No PIRADS 5 lesion on multiparametric prostate MRI (1.5T or 3T)
  • Participants must be willing to attend the follow-up visits - T1a-b disease should be confirmed by systematic TRUS-Bx ≥ 10 cores

排除标准

  • A former therapy for prostate cancer.

结局指标

主要结局

Pathological reclassification

时间窗: 5 year

5-year rate of pathological reclassification during active surveillance

次要结局

  • rates of active surveillance maintenance(1, 3, 5, 7, 10 years)
  • Utility value (measured by EQ-5D-5L)(1, 3, 5, 7, 10 years)
  • metastasis-free survival(3, 5, 10 years)
  • overall survival(3, 5, 10 years)
  • active treatment-free survival(1, 3, 5, 7, 10 years)
  • HRQoL scores (measured by EPIC-CP)(1, 3, 5, 7, 10 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chang Wook Jeong

Professor

Seoul National University Hospital

研究点 (1)

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