A Randomised Controlled Trial Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of Clinically Significant Prostate Cancer: the PROFUSION Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,250
- 试验地点
- 1
- 主要终点
- Proportion of men with clinically significant Prostate cancer(csPCa)
研究概览
简要总结
This study is an international multicentre RCT to compare the linically significant prostate cancer (csPCa) detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion.
详细描述
This study is an international multicentre RCT to compare the csPCa detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion. This is a phase III randomised controlled trial to evaluate the detection of clinically significant prostate cancer (csPCa) by MRI-USG fusion approach (MRUS arm) versus Cognitive-guided approach (COG arm). The study hypothesis is that MRUS arm is superior to COG arm in detecting csPCa. The result of this RCT would impact how MRI-guided prostate biopsies should be done in the future. If the MRI-USG fusion approach is superior to cognitive-guidance in csPCa detection, it should be the standard of practice in the future, and dedicated MRI-USG fusion equipment should be available in centres performing prostate biopsies.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Men ≥18 years of age
- •Clinical suspicion of prostate cancer and indicated for prostate biopsy
- •Serum Prostate-specific antigen (PSA) < 20 ng/mL
- •Digital rectal examination ≤ cT2 (organ-confined cancer)
- •Able to provide written informed consent
- •MRI prostate (contrast or plain) showing 1-3 suspicious lesion(s) with PI-RADS score 3-5
排除标准
- •Prior prostate biopsy in the 2 years before screening visit
- •Prior diagnosis of prostate cancer
- •Contraindicated to prostate biopsy: active urinary tract infection, failed insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (continue low-dose aspirin before and after biopsy is permitted)
- •Patient refusal for biopsy
研究组 & 干预措施
MRUS arm
Targeted biopsies will be performed by software-assisted MRI-ultrasound fusion registration . Software-based fusion targeted biopsy of 4 cores per target followed by 12-core systematic biopsy will be performed. The fusion or overlay of 3D MRI and USG images create a detailed 3D prostate image with both targeted and systematic biopsy core locations recorded.
干预措施: MRI-USG fusion approach (Procedure)
COG arm
The biopsy operator reviews the MR images and creates a mental three-dimensional representation of the prostate and the lesion within it to guide biopsy. Cognitive registration is a visual guidance technique in which the surgeon samples a visually estimated location on transrectal ultrasound (TRUS) corresponding to the MRI suspicious regions. Cognitive-guided biopsy is performed by taking 4 cores from each target followed by 12-core systematic biopsies.
干预措施: Cognitive-guided approach (Procedure)
结局指标
主要结局
Proportion of men with clinically significant Prostate cancer(csPCa)
时间窗: When histology results available, at an expected average of 30 days post-biopsy
ISUP Grade 2 or above prostate cancer diagnosed on biopsy
次要结局
- Proportion of men with post-biopsy adverse events within 30 days after biopsy(30 days post biopsy)
- Proportion of men with a diagnosis of csPCa in MRI lesions with maximal size ≤10mm versus >10mm(When histology results available, at an expected average of 30 days post-biopsy)
- Proportion of men with a diagnosis of csPCa in prostate size of ≤50ml vs >50m(When histology results available, at an expected average of 30 days post-biopsy)
- Proportion of men with a diagnosis of clinically insignificant PCa,(When histology results available, at an expected average of 30 days post-biopsy)
- The proportion of men with a diagnosis of csPCa only in targeted biopsy(When histology results available, at an expected average of 30 days post-biopsy)
- Proportion of men with a diagnosis of csPCa only in systemic biopsy(When histology results available, at an expected average of 30 days post-biopsy)
- Procedure time(During biopsy procedure)
- Pain score on a scale of 0-10 taken after biopsy(Immediately After biopsy procedure)
研究者
CHIU Ka Fung Peter
Associate Professor
Chinese University of Hong Kong