Utilizing 68Ga-PSMA PET/MRI Imaging in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- PPV of concordant PET/MRI lesion plus PI-RADS score 4~5
研究概览
简要总结
The goal of this observational study is to learn if Ga-68 PSMA PET/MRI can better diagnose prostate cancer than mpMRI in males between 40 to 85 years old who is naive to prostate biopsy and is suspicious for prostate cancer by elevated PSA or lower urinary tract symptoms. The main questions it aims to answer are:
- Does PSMA PET/MRI have better PPV and NPV than mpMRI to diagnose prostate cancer?
- Does lesion location concordance in PSMA PET and MRI effect diagnosis accuracy?
Participants will:
- Undergo a Ga-68 PSMA PET/MRI scan and keep followed up for 2 years to check if prostate cancer is diagnosed after the scan.
- Between the follow-up period, visit the clinic once every 6 months for checkups and blood tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients who indicated MRI of pelvis due to clinical suspicion of prostate cancer based on elevated PSA (4~20 ng/mL), abnormal digital rectal examination or lower urinary tract syndromes.
- •Males aged between 40 and 85 years with a life expectancy greater than two years.
- •Naïve to prostate biopsy in the past.
- •Assessment of daily physical status graded 0 to 2 based on the Eastern Cooperative Oncology Group (ECOG) criteria.
- •Willing to sign the informed consent.
排除标准
- •Unable to tolerate the PET/MRI scan, such as those with claustrophobia, unable to lie still, consciousness unclear, vital sign unstable, or having MRI unsafe metallic implants or devices.
- •With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast.
- •High risk to conduct examination after evaluations of PI
- •Patient had previous malignancy history
结局指标
主要结局
PPV of concordant PET/MRI lesion plus PI-RADS score 4~5
时间窗: 2 years after PSMA PET/MRI scan
Comparing positive predictive values (PPV) of using concordant PET/MRI lesion plus PI-RADS score 4\~5 as positive test with PPV of using PI-RADS 4\~5 alone as positive test to predict diagnosing prostate cancer within 2 years.
NPV of using negative PET lesion plus PI-RADS score 1~3
时间窗: 2 years after PSMA PET/MRI scan
Comparing negative predictive values (NPV) of using negative PET lesion plus PI-RADS score 1\~3 as negative test with NPV of using PI-RADS 1\~3 alone as negative test to predict diagnosing prostate cancer within 2 years.
次要结局
未报告次要终点