Diagnostic Efficiency With Magnetic Resonance Imaging-targeted Biopsy Compared to Standard Transperineal Ultrasound-guided Biopsy in Biopsy-naïve Suspicious Prostate Cancer Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Detection rates of clinically significant PCa
研究概览
简要总结
This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of mpMRI-targeted biopsy compared to transperineal standard biopsy in men with clinical suspicion of prostate cancer who had no prior prostate biopsy.
详细描述
Prostate biopsy with multiple samples using a standardized template (standard biopsy, SB) under transrectal ultrasound (TRUS) guidance is the current standard diagnostic approach in suspicion of prostate cancer (PCa). However, many biopsies are unnecessary or cannot detect clinically significant PCa (csPCa).
With the introduction of multiparametric magnetic resonance imaging (mpMRI) of the prostate and the improvement for PCa detection and localization, an alternative procedure, known as MRI-targeted biopsy (TB), has been shown comparable or even higher detection rates of csPCa compared to TRUS-biopsy (SB).
This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of TB compared to SB (transperineal) in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（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;
- •mpMRI PI-RADS V2 score 4 or 5；
- •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.
研究组 & 干预措施
target biopsy group
Targeted prostate biopsy
干预措施: Targeted prostate biopsy (Procedure)
standard biopsy group
Standard prostate biopsy
干预措施: Standard biopsy (Procedure)
结局指标
主要结局
Detection rates of clinically significant PCa
时间窗: 30 days post biopsy
Clinically significant prostate cancer is considered as: biopsy Gleason score ≥3+4 or maximum cancer core length ≥5 mm.
次要结局
- Proportion of men undergoing radical prostatectomy who have Gleason grade upgrading(90 days post-biopsy)
- Detection rates of clinically insignificant PCa(30 days post biopsy)
- Biopsy-related adverse events(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