NCT06375629终止不适用
A Multi-institutional Prospective Data Collection of Patients Treated With Partial Gland High-Intensity Focused Ultrasound (HIFU) Ablation for Prostate Cancer
EDAP TMS S.A.5 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2023年4月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 5
- 主要终点
- Evaluation of urinary incontinence
研究概览
简要总结
The objective of this study is to evaluate the clinical effectiveness and safety of treatment of prostate cancer in patients who have received a focal HIFU treatment using the Focal One medical device.
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
- •Patient eligible for HIFU treatment for prostate cancer, excluding whole gland treatment.
- •Patient newly diagnosed with localized prostate cancer confirmed with an image guided biopsy (MRI and/or micro-ultrasounds).
- •Gleason ≤ 4+
- •Patient scheduled for HIFU treatment as determined by the physician.
- •Patient with healthcare coverage. Spanish-speaking patients with the ability to provide informed written consent
排除标准
- •Patient with bilateral prostate cancer requiring whole gland treatment.
- •Patients clinically detected metastasis.
- •Patient with an extension of cancer or seminal vesicle invasion.
- •Patient with contraindications for HIFU treatment: please refer to the complete Focal One user manual.
结局指标
主要结局
Evaluation of urinary incontinence
时间窗: 3, 6, 9 and 12 months
ICIQ questionnaire
Erectile function assessment
时间窗: 3, 6, 9 and 12 months
IIEF-5 questionnaire
Evaluation of adverse events
时间窗: 1 year
using the Clavien-Dindo classification
Evaluation of quality of life
时间窗: 3, 6, 9 and 12 months
IQL questionnaires
Urinary Symptoms
时间窗: 3, 6, 9 and 12 months
IPSS questionnaire
次要结局
未报告次要终点
研究者
研究点 (5)
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