NCT05822726招募中不适用
The Combination of PSMA-PET/MRI and p2PSA in Early Diagnosis of Prostate Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- biospy outcome
研究概览
简要总结
This is a single center prospective non-randomized controlled study.
The goal of this clinical trial is to figure out whether the combination of PSMA-PET/MR and PHI could add values to each method alone. The main questions it aims to answer are:
- Compare the diagnostic value of the combination with each alone and set up a diagnostic model.
- Compare the diagnostic value of PSMA-PET/MR+PHI to mpMRI+PHI.
- Evaluate the diagnostic value the combination of PHI and PSMA-PET/MR in suspected PCA patients.
Patients will experience mpMRI or PSMA-PET/MR and their blood samples will be used to test PSA and p2PSA. Prostate biopsy will be the golden standard.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Preoperative clinical judgment of suspected early prostate cancer (according to NCCN guidelines): meet PSA ≤ 20ng/ml and clinical stage<T3, while meeting one of the following criteria:
- •① Digital rectal examination revealed suspicious nodules of the prostate;
- •② Transrectal prostate ultrasound or MRI found suspicious lesions;
- •③ PSA>10 ng/ml；
- •④ PSA 4~10ng/ml, f/t PSA suspicious or PSAD value suspicious;
- •Aged between 18 and 85 years;
- •Generally in good health, able to tolerate and cooperate with research interventions, such as prostate biopsy and radical prostatectomy Etc;
- •Provide a signed and dated informed consent form;
- •Commit to complying with research procedures and cooperate in the implementation of the entire process of research.
排除标准
- •Preoperative clinical characteristics of suspected high-risk prostate cancer (according to NCCN guidelines): meet PSA>20 ng/ml or clinical stage ≥ T3;
- •Have received any treatment (endocrine therapy, radiotherapy, chemotherapy, prostate resection, etc.)
- •Have had prostatitis (infectious or non infectious) 3 months before the examination
- •Taking 5a reductase inhibitors
- •Previously diagnosed with prostate cancer
- •In the acute infection period and fever period;
- •Have a hypertensive crisis;
- •In the period of decompensation due to cardiac insufficiency;
- •Diseases with a tendency to severe bleeding;
- •In diabetes, blood sugar is unstable;
- •Have severe internal and external hemorrhoids, perianal or rectal lesions;
- •Combined with other systemic malignant tumors;
- •Implantation of functional electronic devices and various stimulators such as cardiac pacemakers, cochlear implants, and cardiac stents in vivo, with implants made of ferromagnetic materials (such as iron, cobalt, nickel, etc.);
- •A perfusion device implanted in the body, such as insulin or other perfusion pumps;
- •Have a history of surgery within the past 3 months, especially organ transplantation, heart and kidney surgery;
- •People with claustrophobia.
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 both methods and set up a diagnostic model.
次要结局
未报告次要终点
研究者
研究点 (1)
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