The Diagnostic Application of PSMA PET/MR in Patients with PSA <20 Ng/ml and Initial Negative Prostate Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Biospy outcome
研究概览
简要总结
The present study is designed to explore the value of targeted puncture guided by PSMA PET/CT or mpMRI in the diagnosis of patients with low PSA and initial negative prostate biopsy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥40 years, male;
- •Serum PSA level 4-20 ng/mL;
- •Serum PSA level 4-20 ng/mL;
- •No contraindications to PSMA-PET/CT or MRI;
- •Signed informed consent.
排除标准
- •Serum PSA >20 ng/mL;
- •History of prostate surgery/radiotherapy;
- •Acute prostatitis;
- •Coagulation disorders or active infection;
- •Severe internal/external hemorrhoids, perianal, rectal, or gluteal lesions;
- •Allergy to local anesthetics;
- •Inability to tolerate the biopsy procedure.
研究组 & 干预措施
PET+/mpMRI+ group
Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show positive findings on both PSMA PET and mpMRI. These patients will undergo prostate biopsy guided by PSMA PET/CT.
干预措施: Prostate biopsy guided by PSMA PET/CT (Diagnostic Test)
PET+/mpMRI- group
Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show positive findings on PSMA PET and negative on mpMRI. These patients will undergo prostate biopsy guided by PSMA PET/CT.
干预措施: Prostate biopsy guided by PSMA PET/CT (Diagnostic Test)
PET-/mpMRI+ group
Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show negative findings on PSMA PET and positive on mpMRI. These patients will undergo prostate biopsy guided by mpMRI and US.
干预措施: Prostate biopsy guided by mpMRI/US (Diagnostic Test)
PET-/mpMRI- group
Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show negative findings on both PSMA PET and mpMRI. These patients will undergo systematic prostate biopsy.
干预措施: Systematic prostate biopsy (Diagnostic Test)
结局指标
主要结局
Biospy outcome
时间窗: 12 months
Compare the diagnostic value (including sensitivity, specificity, NPV and PPV) between puncture methods and set up a diagnostic model.
次要结局
- Duration of puncture operation(12 months)
- Patient's pain level(12 months)
- Blood loss(12 months)
- Complication(12 months)