Effectiveness of 68Ga-PSMA PET/MRI for Improving the Detection of Clinical Significant Prostate Cancer in Lesions With Prostate Imaging Reporting and Data System Score 3
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- detection rate
研究概览
简要总结
The purpose of this study was to explore the effectiveness of 68Ga-PSMA PET/MRI for improving the detection of csPCa in lesions with PI-RADS score 3. This study is a prospective, observational study, single-center research. After recruiting patients who are suspected prostate cancer with a mpMRI PI-RADS version2 score of 3 and willing to perform prostate biopsy to identify the diagnosis, 68Ga-PSMA PET/MRI will be performed. Lesions will be reaccessed based on PET/MRI findings and compared with the pathological results.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •males over 18 years old suspected for prostate cancer
- •serum PSA between 4ng/ml and 20ng/ml in recent two months
- •mpMRI PI-RADS version2 scores 3 in recent two months
- •willing to undertake prostate biopsy
- •no evidence of non-cancerous factors interfere PSA level, such as catheter insertion, bladder stones, urinary tract infections or drug (e.g. finasteride)
排除标准
- •history of prostate biopsy or other operations
- •history of prostate cancer associated treatment
- •contraindications for MRI or PET examination (e.g. claustrophobia, pacemakers, hip metal implants, hyperglycemia, glomerular filtration rate less than 50 ml/min)
- •not suitable for prostate biopsy (e.g. coagulation dysfunction, skin infection at perineal puncture site)
结局指标
主要结局
detection rate
时间窗: one year
detection rate of csPCa
次要结局
- detection rate(one year)
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