Transperineal Laser Ablation for Focal Prostate Cancer: Safety and Ablative Efficacy Evaluation Using Postradical Prostatectomy Histological Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Ablative efficacy of transperineal laser ablation determined by size of the ablation zone in histopathology, which is measured by absence of vital prostatic cells, compared to the size measured on imaging (CEUS/MRI) during and after treatment
研究概览
简要总结
Rationale: Prostate cancer (PCa) is the second cause of cancer-related deaths for men. The standard surgical treatment for localised prostate cancer is radical prostatectomy. Possible side effects of this treatment are incontinence and erectile dysfunction and this is related to the whole-gland resection. A focal treatment with fewer side effects is desired for patients with only a small focus of PCa. For this purpose, focal laser ablation is feasible. Current focal laser ablation techniques use a single fibre setup with the need for fibre replacement revisualisation of the tumour side accordingly. This leads to a long treatment duration.
The Echolaser® system is a laser ablation system with four simultaneously operating laser sources. This provides a potential larger treatment area, without the need for fibre replacement.
This makes the system advantageous for focal laser ablation of prostate cancer, especially since it can be applied under local anaesthesia.
This pilot study aims to evaluate histological ablative efficacy on radical prostatectomy specimens following TPLA, feasibility and safety using a (multi)fibre setup in men with localized prostate cancer. The investigators hypothesize that TPLA will show adequate histological ablative efficacy and will be feasible and safe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •≥40 years of age
- •Histopathological confirmed organ-confined prostate cancer
- •Indication for a radical prostatectomy
- •Prostate volume ≥40 mL
- •Ability of the patient to stop anticoagulant therapy prior to TPLA according to standard hospital pre-operative protocol
- •Signed informed consent
排除标准
- •Refusal of participation or clinically ineligible for treatment under local anaesthesia
- •Prior or concurrent treatment for prostate cancer
- •Other conditions / status
结局指标
主要结局
Ablative efficacy of transperineal laser ablation determined by size of the ablation zone in histopathology, which is measured by absence of vital prostatic cells, compared to the size measured on imaging (CEUS/MRI) during and after treatment
时间窗: 30 days following TPLA treatment
Histological ablative efficacy is assessed on histopathological analysis of the prostatic tissue after radical prostatectomy by means of the absence of vital cells in the treated prostate zone
次要结局
- Safety is assessed by device and procedural adverse events using the CTCAEv5.0 until radical prostatectomy and feasibility is determined by procedural success of the TPLA treatment.(30 days following TPLA treatment)
- Observation of tissue changes seen on imaging during and after treatment compared to histopathology(30 days following TPLA treatment)
- Size of ablation zone(30 days following TPLA treatment)
- Functional outcomes measured using PROMs (VAS, IPSS, IIEF-15, EPIC)(30 days following TPLA treatment)
研究者
Prof.dr. H.P. Beerlage
Head of Urology department
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)