Comparison of Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed TRUS Guided (Cognitive Fusion) Prostate Biopsy in PIRADS 4 and 5 Lesions: A Pilot Study to Assess Diagnostic Performance and Patient Safety
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 217
- 试验地点
- 2
- 主要终点
- Diagnostic yield of mpMRI directed vs PET/CT directed prostate biopsy
研究概览
简要总结
The present study aimed to compare the diagnostic accuracy, radiation exposure, complication rates between 68Ga-PSMA PET/CT guided robotic arm assisted prostate biopsy and MRI directed TRUS guided prostate biopsy in PIRADS 4/5 lesions.
详细描述
To compare the diagnostic yield of Robotic-arm assisted 68Ga PSMA PET/CT guided prostate biopsy and MRI directed TRUS guided prostate biopsy in patients with PIRADS grading 4/5.
To compare the visual pain index of the patients between two arms during the procedure.
To compare the complication rates between the two arms during and after the procedure for a period of 2 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •PIRADS 4 and 5 prostate lesions and PIRADS </= 3 prostate lesions with high clinical suspicion.
- •Patients who are included in the study will be randomly allocated into either PSMA PET/CT guided biopsy or TRUS guided biopsy using simple randomization in RRApp
排除标准
- •Patients with acute prostatitis/ urine culture positive.
- •Patients with pre-existing bleeding diathesis like hemophilia, coagulopathy defined by INR ≥ 1.2, and Platelet counts ≤ 80,000/mm3
- •Patients who refuse to provide the written informed consent
- •Non-cooperative patients
结局指标
主要结局
Diagnostic yield of mpMRI directed vs PET/CT directed prostate biopsy
时间窗: 12 months
The number of participants (with percentages) in whom the biopsy procedure yielded a tissue specimen adequate for a definite pathological diagnosis and detection of PCa in both arms
Diagnostic performance of mpMRI directed vs PET/CT directed prostate biopsy
时间窗: 12 months
The sensitivity, specificity and accuracy of mpMR directed TRUS guided (cognitive fusion) and PSMA PET/CT directed biopsy will be compared.
Diagnostic yield of mpMRI directed vs PET/CT directed prostate biopsy
时间窗: 12 months
The number of participants (with percentages) in whom the biopsy procedure yielded a tissue specimen adequate for a definite pathological diagnosis and detection of PCa in both arms
Diagnostic performance of mpMRI directed vs PET/CT directed prostate biopsy
时间窗: 12 months
The sensitivity, specificity and accuracy of mpMR directed TRUS guided (cognitive fusion) and PSMA PET/CT directed biopsy will be compared.
次要结局
- Incidence of procedure related complications(three months)
研究者
Rajender Kumar
Additional Professor
Post Graduate Institute of Medical Education and Research, Chandigarh