Inclusion of POSLUMA® ((18)F-rhPSMA-7.3) PET-CT Imaging Improves Diagnostic Accuracy of Clinically-Significant Prostate Cancer Diagnosis in Men With PIRADS 2 and 3 Lesions on MRI
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in positive predictive value (PPV)
研究概览
简要总结
The goal of this study to determine if using the (18)F-rhPSMA-7.3 PET-CT scan can improve the ability to spot serious prostate cancer in patients who have uncertain MRI results. These uncertain results include MRI results that showed a PIRADS 2 or PIRADS 3 area on the prostate. The investigators want to find out if this new test is better to detect prostate cancer than just doing a biopsy based on MRI alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The patient is willing to provide signed informed consent and is able to comply with all required study-related procedures, where safe and feasible.
- •The patient is male and at least 18 years of age.
- •The patient has not previously undergone a prostate biopsy.
- •The patient underwent a pelvic mpMRI within the last 90 days for the detection of potential prostate cancer (Pca).
- •The patient is a candidate for a targeted MRI/US biopsy and is scheduled to undergo the procedure. Only patients scheduled for a biopsy before recruitment will be considered candidates.
- •The patient has PIRADS 2 and/or PIRADS 3 lesions detected by a board-certified radiologist.
排除标准
- •Patients with a prior diagnosis of prostate cancer.
- •Patients with any medical condition or circumstance that, in the investigator's opinion, could compromise the study data or prevent the patient from fulfilling the study requirements.
- •Patients participating in another interventional clinical trial within the past 30 days.
- •Patients with known hypersensitivity to the active substance or any excipients of flotufolastat F 18 PET-CT.
研究组 & 干预措施
POSLUMA PET scan
Eligible participants will undergo a PSMA PET scan after infusion of POSLUMA imaging agent.
干预措施: Flotufolastat F 18 (Drug)
结局指标
主要结局
Change in positive predictive value (PPV)
时间窗: From enrollment to the end of treatment visit at roughly 12 weeks.
Evaluate the change in PPV for detecting clinically significant prostate cancer (csPCa) cores by comparing results from mpMRI alone (PIRADS 2 and 3 lesions) to the combination of mpMRI with flotufolastat F 18 PET-CT.
Change in negative predictive value (NPV)
时间窗: From enrollment to the end of treatment visit at roughly 12 weeks.
Measure the change in NPV for detecting csPCa cores by comparing mpMRI findings alone (PIRADS 2 and 3 lesions) with the combined approach of mpMRI and flotufolastat F 18 PET-CT.
Improvement in Accuracy
时间窗: From enrollment to the end of treatment visit at roughly 12 weeks
Assess the improvement in accuracy (accuracy defined as \[(true positive + true negative) / total number of subjects\] when using the combined imaging approach of flotufolastat F 18 PET-CT with mpMRI versus mpMRI alone in patients with PIRADS 2 and 3 lesions.
次要结局
未报告次要终点