Combining High-frequency Micro-ultrasound Target Biopsy and Multiparametric MRI Target Biopsy - Does it Increase the Detection Rate of Clinically Significant Prostate Cancer? A Prospective, Interventional, Single Centre, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Detection of Clinically Significant Prostate Cancer via Prostate Biopsy
研究概览
简要总结
**Study Goal:** The purpose of this clinical trial is to determine if combining high-frequency micro-ultrasound with multiparametric MRI biopsy and a systematic biopsy can better detect clinically significant prostate cancer compared to current standard methods. This study is aimed at men who may have prostate cancer.
**Main Questions the Study Aims to Answer:**
- Does the combination of new biopsy methods detect more clinically significant prostate cancers than the current standard method?
- Does the new method not increase the detection of less serious forms of cancer beyond what the standard method detects?
**Participation in the Study:**
Participants in this study will undergo the following procedures:
- A high-frequency micro-ultrasound examination of the prostate.
- A multiparametric MRI-targeted biopsy of the prostate.
- A systematic biopsy of the prostate.
**Comparison Group:** Researchers will compare the new combination method with the current standard method to see if the new approach is more effective.
**Participants will:**
- Undergo several exams and biopsies depending on the results of previous tests.
- Attend regular follow-up appointments to monitor potential side effects and evaluate prostate health.
- Record their experiences and any symptoms in a diary.
详细描述
The primary objective of this study is (i) to demonstrate that the combination of highfrequency micro-ultrasound target biopsy, multiparametric MRI target biopsy, and systematic biopsy detects more clinically significant prostate cancer (>= ISUP 2) than multiparametric MRI target biopsy and systematic biopsy alone (current standard of care).
The secondary objective of this study is (ii) to demonstrate that the combination of high frequency micro-ultrasound target biopsy, multiparametric MRI target biopsy, and systematic biopsy does not detect more clinically insignificant prostate cancer (ISUP 1) than multiparametric MRI target biopsy and systematic biopsy alone (current standard of care).
The third objective of this study is (iii) to demonstrate that the combination of highfrequency micro-ultrasound target biopsy and multiparametric MRI target biopsy does not detect less clinically significant prostate cancer (>= ISUP 2) than multiparametric MRI target biopsy and systematic biopsy (current standard of care).
The fourth objective of this study is (iv) to demonstrate that the combination of highfrequency micro-ultrasound target biopsy and multiparametric MRI target biopsy detects less clinically insignificant prostate cancer (ISUP 1) than the combination of multiparametric MRI target biopsy and systematic biopsy (current standard of care).
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 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •- Men with suspected clinically significant prostate cancer, identified by the rise in PSA level, suspicious digital rectal examination or both and pathologic multiparametric MRI of the prostate (>= PI-RADS III)
排除标准
- •Patients with histopathologic proven prostate cancer
- •PSA > 20 ng/ml
- •Finding in digital rectal examination >= cT2c
- •Untreated bacterial infection of the prostate
- •Untreated coagulopathy
研究组 & 干预措施
Group U
Use of high-frequency micro-ultrasound target biopsy, multiparametric MRI target biopsy and systematic biopsy for tumor detection
干预措施: High-frequency micro-ultrasound target biopsy (Device)
Group S
Use of multiparametric MRI target biopsy and systematic biopsy (current standard of care) for tumor detection
干预措施: conventional Multiparametric MRT target biopsy (Device)
结局指标
主要结局
Detection of Clinically Significant Prostate Cancer via Prostate Biopsy
时间窗: 2 Weeks
This measure assesses whether participants have clinically significant prostate cancer (Gleason Score Sum ≥ ISUP 2) based on biopsy results, recorded as "yes" or "no".
次要结局
- Detection of Clinically Insignificant Prostate Cancer via Prostate Biopsy(2 Weeks)
研究者
Maximilian Pallauf
Biopsy29
Salzburger Landeskliniken