跳至主要内容
临床试验/NCT04602208
NCT04602208已完成不适用

FOCAL HIGH-INTENSITY FOCUSED ULTRASOUND FOR PRIMARY LOCALIZED PROSTATE CANCER: MIDTERM ONCOLOGICAL OUTCOMES

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
146
试验地点
1
主要终点
Retreatment-free survival (RFS)

研究概览

简要总结

Single-center evaluation of all patients treated for primary localized prostate cancer with focal HIFU from November 2009 to December 2016. To evaluate midterm oncological outcomes of focal HIFU therapy in low an intermediate risk prostate cancer.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • • The patients with low or intermediate risk PCa (PSA <20 ng/ml, Gleason score 7 or less and clinical stage T2b or less) who received PGA/FT using HIFU were included.

排除标准

  • Patients who were previously treated with radiotherapy, androgen deprivation therapy (ADT) or other treatment for their prostate cancer were excluded.

结局指标

主要结局

Retreatment-free survival (RFS)

时间窗: May 1, 2020

The study primary outcome was retreatment-free survival (RFS) defined as any additional further treatment: local (FT/PGA for in-field or out-of-field recurrences or radical prostatectomy or external beam radiotherapy or whole gland HIFU) or systemic salvage treatment, a positive biopsy revealing PCa with an ISUP grade≥ 2 in nontreated patients, PCa metastasis or PCa specific death.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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