A Prospective, Single-center, Randomized Controlled Trial Comparing the Functional and Oncological Outcomes of High-frequency Irreversible Electroporation and Laparoscopic Radical Prostatectomy in Men With Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- urinary function measured by EPIC
研究概览
简要总结
This trial is comparing the functional and oncological outcomes in treating men with prostate cancer between high-frequency irreversible electroporation and laparoscopic radical prostatectomy.
详细描述
Two hundred and sixteen patients with localized prostate cancer will include in this study. The clinical trial validation process will be as follows: (1) all patients are randomly divided into two arms: arm 1, high-frequency irreversible electroporation; group 2, laparoscopic radical prostatectomy. The primary outcome is the urinary function and sexual function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age less than 80 years old.
- •PSA<20ng/ml.
- •Clinical stage ≤T2c.
- •Biopsy Gleason score ≤4+
- •No evidence of metastasis.
- •Fully understand the clinical trial protocol and sign the informed consent
排除标准
- •Any previous treatment to PCa.
- •Any previous surgery within 3 months.
- •Contraindications to MRI, bone scan, or PSMA-PET (eg, metal implant, contrast agent allergy).
- •History of any other malignant tumour.
- •Any other conditions that make the investigator judge that participants are not suitable for this trial.
结局指标
主要结局
urinary function measured by EPIC
时间窗: 24 months
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
urinary function measured by IPSS
时间窗: 24 months
The urinary function will be measured by IPSS (International Prostate Symptom Score)
sexual function measured by EPIC
时间窗: 24 months
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
urinary function measured by ICIQ
时间窗: 24 months
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
urinary function measured by separate EPIC pad-use item
时间窗: 24 months
The urinary function will be measured by a separate EPIC pad-use item
sexual function measured by IIEF-5
时间窗: 24 months
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
次要结局
- Perioperative data (operative time)(1 month)
- Perioperative data (hemoglobin loss)(1 month)
- Rates of adjuvant therapy(24 months)
- Quality of life measure by EPIC sexual domain bother score(24 months)
- Quality of life measure by EPIC bowel domain bother score(24 months)
- Quality of life measure by EORTC QLQ-C30(24 months)
- Quality of life measure by EPIC urinary domain bother score(24 months)
- Quality of life measure by HADS(24 months)
- Adverse effect(24 months)
- Number of patients with Disease progression(24 months)
- Perioperative data(the length of indwelling catheter stay)(1 month)
- Bowel function(24 months)
- Rates of primary treatment failure(24 months)
- Pain (measured by a surgical pain scale range from 0 to 10)(6 months)
- Perioperative data (blood transfusion)(1 month)
- Perioperative data (the length of hospital stay)(1 month)