ESCAPE - Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Negative predictive value (NPV)
研究概览
简要总结
This study will be assessing the ability of PSMA-PET CT to determine the absence of clinically significant prostate cancer in patients on active surveillance (AS) with low risk and favorable intermediate-risk prostate cancer.
详细描述
This is a prospective, multicenter, nonrandomized single-arm study assessing the diagnostic accuracy of PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) in determining the absence of clinically significant prostate cancer in patients on active surveillance (AS).The trial will enroll 200 subjects for low and favorable intermediate-risk prostate cancer patients per NCCN guidelines who have elected to pursue active surveillance.
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 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged ≥
- •Histologically confirmed low or favorable intermediate risk prostate cancer per NCCN guidelines. (Note: Grade Group 2 must have 20% or less involvement in every core and no presence of cribiform or intraductal carcinoma).
- •PSA < 20 ng/ml.
- •Ability to undergo yearly PSMA-PET CT.
- •Ability to undergo yearly prostate mpMRI.
- •Ability to undergo transrectal or transperineal template and fusion prostate biopsy.
- •Willingness to undergo yearly prostate biopsies.
排除标准
- •History of prior treatment for prostate cancer.
- •History of systemic therapy for prostate cancer.
- •Inability to undergo transrectal ultrasound.
- •Life expectancy less than 10 years.
- •Not interested in pursuing active surveillance.
- •Initial diagnosis of prostate cancer greater than 15 months.
研究组 & 干预措施
PSMA-PET CT
Patients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) at baseline, 12 month and 24 month time point.
干预措施: PSMA-PET CT (Diagnostic Test)
结局指标
主要结局
Negative predictive value (NPV)
时间窗: 24 months
Negative predictive value (NPV): The NPV is defined as the number of negative image results with identified clinically insignificant prostate cancer on biopsy divided by the number of negative image results.
Negative predictive value (NPV)
时间窗: Baseline
Negative predictive value (NPV): The NPV is defined as the number of negative image results with identified clinically insignificant prostate cancer on biopsy divided by the number of negative image results.
Negative predictive value (NPV)
时间窗: 12 months
Negative predictive value (NPV): The NPV is defined as the number of negative image results with identified clinically insignificant prostate cancer on biopsy divided by the number of negative image results.
次要结局
- Positive predictive value (PPV) of PSMA PET.(24 months)
- Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.(24 months)
- Number of positive scans on mpMRI(24 months)
- Number of negative scans on PSMA-PET(24 months)
- Number of patients with negative PSMA pet scan.(24 months)
- Number of positive scans on PSMA-PET(24 months)
- Number of negative scans on both PSMA-PET and mpMRI(24 months)
- Number of positive scans on both PSMA-PET and mpMRI(24 months)
- Number of negative scans on mpMRI(24 months)
- Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.(24 months)
- Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.(24 months)
- Positive predictive value (PPV) of PSMA PET.(Baseline)
- Positive predictive value (PPV) of PSMA PET.(12 months)
- Number of patients with negative PSMA pet scan.(Baseline)
- Number of patients with negative PSMA pet scan.(12 months)
- Number of positive scans on mpMRI(Baseline)
- Number of positive scans on mpMRI(12 months)
- Number of positive scans on PSMA-PET(Baseline)
- Number of positive scans on PSMA-PET(12 months)
- Number of positive scans on both PSMA-PET and mpMRI(Baseline)
- Number of positive scans on both PSMA-PET and mpMRI(12 months)
- Number of negative scans on mpMRI(Baseline)
- Number of negative scans on mpMRI(12 months)
- Number of negative scans on PSMA-PET(Baseline)
- Number of negative scans on PSMA-PET(12 months)
- Number of negative scans on both PSMA-PET and mpMRI(Baseline)
- Number of negative scans on both PSMA-PET and mpMRI(12 months)
- Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.(Baseline)
- Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.(12 months)
- Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.(Baseline)
- Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.(12 months)
- Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.(Baseline)
- Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.(12 months)