GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies (GUIDE PSMA PET/MRI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Detection rate of clinically significant prostate cancer (csPCa) for PSMA guided biopsies vs systematic biopsies
研究概览
简要总结
The goal of this clinical study is to test the performance of PSMA PET/MRI-guided biopsies against systematic biopsies in men with negative MRI scan (PI-RADS 1-2) of the prostate with continuous suspicion of clinically significant prostate cancer (csPCa) due to PSAd > 0.20. The main questions it aims to answer are:
Can biopsies safely be avoided at PRIMARY score 1-2 without missing csPCa? Does targeted PSMA PET/MRI-guided biopsies have a higher detection rate of csPCa compared to systematic biopsies?
Participants will undergo both transperineal MRI/ultrasound fusion target biopsies from PRIMARY score 3-5 lesions on PSMA PET and systematic biopsies irrespective of the PRIMARY-lesion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •PSAdensity > 0.20
- •Negative MRI (PI-RADS 1-2) or negative biopsy from MRI-target
- •MRI within 6 months
- •Read and understand danish
- •Expected remaining lifetime > 10 years
排除标准
- •Known prostate cancer
- •MRI contraindications
结局指标
主要结局
Detection rate of clinically significant prostate cancer (csPCa) for PSMA guided biopsies vs systematic biopsies
时间窗: From enrollment to pathology report is ready, assessed up to 2 years
CsPCa is defined as "International Society of Urological Pathology" (ISUP) grade ≥ 2. The ISUP grade scale ranges from 1 to 5, where grade 1 is low-risk / indolent / non-significant prostate cancer and grade 5 is the most aggressive prostate cancer form with worse outcome.
次要结局
- High negative predictive value for having csPCa in case of PRIMARY 1-2 (and PI-RADS 1-2)(From enrollment to pathology report, assessed up to 2 years)
研究者
Mads Ryo Jochumsen
MD, Ph.D.
Aarhus University Hospital