AOP2780 - Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 580
- 试验地点
- 2
- 主要终点
- Total number of random and fusion-target biopsies with presence of prostate cancer
研究概览
简要总结
Differences in terms of diagnostic capability and side effects related to the needle caliber used for prostate biopsy sampling in patients with suspected prostate cancer
详细描述
To assess whether a larger caliber (16G) prostate biopsy needle increases the diagnostic capability of prostate neoplasia compared to a smaller caliber (18G) needle, while keeping perioperative complications constant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical suspicion of prostate cancer (presence of elevated prostatic specific antigen and/or suspicious digital rectal examination);
- •Presence of at least one suspicious prostate lesion on MRI (Prostate Imaging-Reporting and Data System ≥ 3) according to the Prostate Imaging-Reporting and Data System v2.1 performed before Magnetic Resonance Imaging/transrectal ultrasound fusion biopsy.
排除标准
- •Patients under active surveillance or with a previous diagnosis of prostate neoplasia prior to biopsy.
- •Previous radiotherapy to the prostate for neoplasia.
结局指标
主要结局
Total number of random and fusion-target biopsies with presence of prostate cancer
时间窗: When histological report available
The primary outcome measure involves assessing the total number of biopsies, including both random and fusion-targeted approaches, that reveal the presence of prostate cancer.
Number of random and fusion-target biopsies with clinically significant prostate cancer (defined as International Society of Urological Pathology >=2)
时间窗: When histological report available
The primary outcome measure focuses on the number and the detection rates of random and fusion-target biopsies revealing clinically significant prostate cancer aof clinically significant prostate cancer (defined as ISUP \>=2) between 16-gauge and 18-gauge biopsy needles.
次要结局
- Neoplasia/core ratio for each random and fusion-target biopsy(When histological report available)
- Number of hospitalizations at 30 and 60 days post-procedure(60 days from biopsy)
- Number of intra- and perioperative complications associated with 18G and 16G needles(30 days)
- Intra- and perioperative pain with 18G and 16G needles assessed using visual analog scale (VAS)(30 days)
研究者
FABIO ZATTONI
MD, Phd
University Hospital Padova