Diagnostic Performance of Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography/Computed Tomography (PET/CT) Imaging for Pre-operative Lymph Node Assessment in Intermediate and High-risk Nonmetastasic Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- To evaluate the sensitivity, specificity and likelihood ratios of PET-PSMA for the detection of lymph node metastases in intermediate- or high-risk prostatic neoplasia in patients whose radical treatment by prostatectomy is selected by the multidisciplinary consultation meeting, by reference to the gold standard (reference test) obtained from histological data and/or imaging follow-up.
研究概览
简要总结
To determine the diagnostic performance of Positron Emission Tomography with Prostate Specific Membrane Antigen Ligands (PET-PSMA) for the detection of lymph node metastases in intermediate or high-risk prostatic neoplasia for which radical treatment by prostatectomy is selected by the multidisciplinary consultation meeting
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age
- •Histologically confirmed prostatic neoplasia
- •Intermediate-risk neoplasia (PSA between 10 and 20 ng/mL and/or TR showing T2b and/or ISUP 2 or 3, AND with risk of lymph node extension > 5% according to the Briganti nomogram) or high-risk neoplasia (PSA ≥ 20 ng/mL and/or TR ≥ T2c and/or ISUP 4 or 5) according to the d'Amico classification
- •Radical treatment by total prostatectomy selected by the multidisciplinary consultation meeting
- •Patient affiliated to or benefiting from a health insurance scheme.
排除标准
- •Refusal or inability to take part in the study
- •Prostatic neoplasia with low risk of extension according to the Amico classification, or intermediate risk but with a risk of lymph node extension <5% according to the Briganti nomogram
- •Curative treatment other than surgery selected
- •Life expectancy < 12 months
- •Karnofsky score < 70 or ECOG score > 2
- •Patient under guardianship or trusteeship
结局指标
主要结局
To evaluate the sensitivity, specificity and likelihood ratios of PET-PSMA for the detection of lymph node metastases in intermediate- or high-risk prostatic neoplasia in patients whose radical treatment by prostatectomy is selected by the multidisciplinary consultation meeting, by reference to the gold standard (reference test) obtained from histological data and/or imaging follow-up.
To evaluate the sensitivity, specificity and likelihood ratios of PET-PSMA for the detection of lymph node metastases in intermediate- or high-risk prostatic neoplasia in patients whose radical treatment by prostatectomy is selected by the multidisciplinary consultation meeting, by reference to the gold standard (reference test) obtained from histological data and/or imaging follow-up.
次要结局
- Modification of the surgical strategy for lymph node dissection on the basis of the PET-PSMA examination, compared with the strategy that would have been dictated by conventional imaging alone.
- Existence of a pathological focus according to each of the 3 examinations (PET-PSMA, MRI and anatomopathology = gold standard) for each of the 6 following locations: base, middle, prostatic apex (right and left)
- Positive predictive value of PET-PSMA in the detection of distant visceral or bone metastases, taking as the gold standard the diagnosis made by a review committee in the light of the patient's follow-up and the results available in current practice (clinical data, anatomopathology, repeated PSA tests and imaging).
- Adverses events recorded during the assessment
研究者
Pr Philippe ROBIN
Scientific
Centre Hospitalier Regional Et Universitaire De Brest