Transperineal Laser Ablation for Low and Intermediate Risk Prostate Cancer: a Single Cohort Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Oncological outcomes PSA
研究概览
简要总结
The goal of this prospective study is to test the efficacy of Echolaser transperineal focal therapy in patients with low- and intermediate risk prostate cancer. The main question it aims to answer are: 1. short and intermediate term oncological outcomes after laser focal therapy, 2. functional outcomes and quality of life after treatment. Participants affected by low risk prostate cancer will undergo trans perineal laser focal therapy. Multiparametric prostate MRI will be perform after 3 and 12 months for oncological control. Re-fusion biopsy will be perform after 12 months. Functional outcomes and quality of life will be assess at 3, 6 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with low- and intermediate risk prostate cancer classified as International Society for Urological Pathology, ISUP 1-2.
排除标准
- •patients diagnosed with urothelial cancer
- •contraindications for MRI
- •Multifocal prostate cancer
结局指标
主要结局
Oncological outcomes PSA
时间窗: 12 months after treatment.
Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual reduction of PSA.
Oncological outcomes Re-biopsy
时间窗: 12 months after treatment
Evaluation of histological outcomes after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual negativity for cancer in a re-biopsy.
Oncological outcomes MRI
时间窗: 12 months after treatment
Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by multiparametric prostate MRI. Specifically, 1. complete ablation, 2. partial ablation or 3. persistence of cancer will be identified.
次要结局
- Quality of life Pain(day after surgery)
- Functional outcomes Erection(3, 6 and 12 months after treatment.)
- Functional outcomes IPSS and IPSS QoL(3, 6 and 12 months after treatment.)
- Functional outcomes Continence(3, 6 and 12 months after treatment.)
- Functional outcomes Ejaculation(3, 6 and 12 months after treatment.)