Prostate Specific Membrane Antigen (PSMA) Scan and Multiparametric MRI for Prostate Biopsy Detection of Clinically Significant Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Detection of Clinically Significant Prostate Cancer
研究概览
简要总结
Prospective, randomized, phase 2 clinical trial to determine if PSMA PET imaging plus mpMRI improves detection of clinically significant prostate cancer as compared to mpMRI alone.
详细描述
This a prospective, randomized, phase 2 clinical trial. We will enroll patients who underwent mpMRI of the prostate as part of their standard clinical care, have PI-RADS 4, or 5 lesion(s) on mpMRI, and are scheduled to undergo fusion guided prostate biopsy. Subjects that sign the consent form will be randomized to undergo DCFPyL PET/CT imaging or no PSMA PET imaging prior to the prostate biopsy. In the PSMA scan cohort, decision for biopsy targets will be made based on the combination of the findings of mpMRI and PSMA scans. In the no PSMA scan (control) group, the biopsy will be performed based on mpMRI findings. Each patient will undergo 12 core systematic biopsy as the standard of care. Two additional biopsies for each mpMRI and PSMA PET and overlap lesion will also performed.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with PI-RADS 4-5 lesion(s) on mpMRI and have elected to undergo a prostate biopsy
- •Prostate mpMRI completed within 9 months prior to enrollment
- •Patient capable of providing written informed consent
- •Patient willing to be randomized to prostate mpMRI only vs prostate mpMRI + DCFPyL PET/CT
排除标准
- •Less than 18 years-old at the time of radiotracer administration
- •Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.
- •Creatinine clearance exceeding institutional requirements for prostate mpMRI
研究组 & 干预措施
PSMA PET+mpMRI
PSMA PET+mpMRI guided prostate biopsy
干预措施: PSMA PET scan (Diagnostic Test)
PSMA PET+mpMRI
PSMA PET+mpMRI guided prostate biopsy
干预措施: 18F- DCFPyl Injection (Drug)
mpMRI only
mpMRI only guided prostate biopsy
干预措施: No PSMA PET (Other)
结局指标
主要结局
Detection of Clinically Significant Prostate Cancer
时间窗: 12 weeks
Percentage of mpMRI and PSMA PET lesions positive for clinically significant prostate cancer
次要结局
- Detection of Clinically Insignificant Prostate Cancer(12 weeks)
- Difference in PSMA PET and mpMRI Clinically Significant Cancer Detection(12 weeks)
- Correlation of AI Measures with Aggressiveness of Prostate Cancer(12 weeks)
- Correlation of PSMA PET intensity with Clinically Significant Prostate Cancer(12 weeks)
- Adverse Events Associated with 18F- DCFPyl(12 weeks)