Evaluation of Feasibility, Complications And Functional Results Of Free-Hand Transperineal Image Fusion Targeted Biopsies Under Local Anesthesia: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,050
- 试验地点
- 1
- 主要终点
- Biopsy unfinished rates
研究概览
简要总结
This trial aims to prospectively assess the feasibility, complications and functional results of free-hand transperineal image fusion targeted biopsies under local anesthesia in a large group of patients.
详细描述
12-core transrectal ultrasound (TRUS) biopsy is one of the most performed urological procedures and remains the standard method for prostate cancer (PCa) histological diagnosis according to the most recent Guidelines. During the last decade, the transperineal prostate biopsy has attracted renewed interest. However, only a few studies and no large prospective studies investigated complications of the transperineal approaches.
Image fusion of Multi-parameter MRI (mpMRI) and TRUS guided prostate targeted biopsy had equivalent results with standard 12-core biopsy. Combination of targeted and standard biopsy was recommended in recent Guidelines. Image fusion targeted biopsy needs satisfactory anesthetic effect, and no prospective studies investigated feasibility in this approach under local anesthesia.
The scientific urological community is focusing on detection rate and concordance with final pathology of the radical prostatectomy specimen, which remain the cornerstones to assess the accuracy of a prostate biopsy technique. In this study, the investigators will additionally assess the functional results of erectile function and urinary function.
Together, the investigators will perform free-hand image fusion targeted biopsies plus standard biopsies under local anesthesia in patients recruited in this study. Then, Feasibility, such as peri-procedural pain, changes in patients quality of life; complications, such as infection rate and bleeding rate; functional results, such as erectile function and urinary function; and concordance with final pathology will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men more than 18 years old with clinical suspicion of prostate cancer;
- •Serum PSA ≤ 20 ng/ml within the previous 3 months;
- •Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months;
- •No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
- •Able to provide written informed consent.
排除标准
- •Prior prostate biopsy or prostate surgery;
- •Prior treatment for prostate cancer;
- •Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min);
- •Contraindication to prostate biopsy.
结局指标
主要结局
Biopsy unfinished rates
时间窗: 1 days
The proportion of patients who failed to complete the biopsy due to various reasons during the biopsy
Pain score
时间窗: 3 days peri-biopsy
Numerical pain scale score during biopsy, the minimum to maximum value is 0 to 10, and higher scores mean a worse outcome
Hospitalization rate due to biopsy
时间窗: 7 days post biopsy
The proportion of subjects requiring hospitalization for various reasons within 7 days after puncture
次要结局
- Detection rates of clinically significant PCa(30 days post biopsy)
- international index of erectile function-5 (IIEF-5) score(30 days post biopsy)
- Detection rates of PCa(30 days post biopsy)
- Biopsy-related complication rates(30 days post biopsy)
- Consistency rate with final pathology(30 days post biopsy)
- Biopsy time(1 days)
- International prostate symptom score (IPSS)(30 days post biopsy)
研究者
Hongqian Guo
Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School