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 Non-metastasic Prostate Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Diagnostic performance of PSMA PET/CT
研究概览
简要总结
In France, prostate cancer is the most common cancer in men over 50 years of age (nearly 50,000 new cases per year) and is the second most common cause of cancer death in men (approximately 9,000 deaths per year). Although mortality has been declining since the end of the 1990s (about 7%/year), about 30 to 35% of them will have a biological recurrence.
Accurate assessment of local, regional and distant spread of the disease is therefore needed to design optimal personalised care for each patient, either curative or palliative.
Currently, in France, recommended disease assessment includes bone scintigraphy and Abdomino-Pelvic Magnetic Resonance Imaging. However, conventional imaging has limited performance with regard to lymph node extension.
Node dissection is the best way to assess node status. Currently, no imaging exam allows this level of accuracy.
Recently, molecular imaging has emerged as a promising tool to improve the initial extensional assessment of prostate cancer. Prostate-specific membrane antigen (PSMA) is a transmembrane glycoprotein, specific to the prostate, which is over-expressed on the surface of prostate cancer cells.
Recent studies of PSMA PET/CT as part of the initial extension assessment of prostate cancer report superior diagnostic performance in terms of sensitivity and specificity compared to conventional tests, as well as an impact of PSMA PET/CT on patient management.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed prostate cancer;
- •Intermediate-risk prostate cancer (PSA level of 10- 20 ng/mL and/or Clinical tumor stage ≥ T2b and/or ISUP 2 or 3, AND with risk of lymph node extension > 5% according to the Briganti nomogram) or high-risk prostate cancer (PSA ≥ 20 ng/mL and/or TR ≥ T2c and/or ISUP 4 or 5) according to d'Amico classification;
- •Curative treatment by radical prostatectomy chosen by the multidisciplinary consultation meeting.
排除标准
- •Refusal or inability to participate in the study ;
- •Low-risk prostate cancer according to D'Amico's classification, or an intermediate-risk but with a risk of lymph node extension <5% according to Briganti's nomogram;
- •Curative treatment other than surgical treatment chosen;
- •Life expectancy < 12 months;
- •Karnofsky score < 70 or ECOG score > 2.
研究组 & 干预措施
Intervention
All patients with prostate cancer undergo PSMA PET/CT as part of the trial in addition to standard methods (abdo-pelvic MRI and a bone scan).
干预措施: PSMA PET/CT (Diagnostic Test)
结局指标
主要结局
Diagnostic performance of PSMA PET/CT
时间窗: Month 12
The main objective of the trial is to determine the diagnostic performance of Positron Emission Tomography of Prostate Specific Membrane Antigen Ligands (PET-PSMA) for the detection of lymph node metastases in intermediate- and high-risk prostate neoplasia, whose radical treatment by prostatectomy is selected by the multidisciplinary consultation meeting.
次要结局
- Impact of PSMA-PET in the surgical strategy of lymph node dissection.(Month 12)
- Comparison of prostate tumor index lesion location on PSMA PET/CT and MRI with prostate histopathology after prostatectomy.(Month 12)
- Diagnostic performance of PSMA PET/CT for distant metastasis(Month 12)
- Impact of PSMA-PET in the surgical strategy of lymph node dissection.(Month 12)
- Comparison of prostate tumor index lesion location on PSMA PET/CT and MRI with prostate histopathology after prostatectomy.(Month 12)
- Diagnostic performance of PSMA PET/CT for distant metastasis(Month 12)
- 68Ga-HBED-CC-PSMA and et du 68Ga- PSMA-11 tolerance(Month 12)