PSMA Radio-Guided Lymph Node Dissection With Beta-Probe, in High-risk Prostate Cancer Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Sensitivity, specificity and positive predictive value in a per-region analysis
研究概览
简要总结
The goal of this observational study is to evaluate the diagnostic efficacy and the safety of the combined approach with β-probe and 68Ga-PSMA-11 PET/CT in the correct identification of lymph node metastases, in high-risk prostate cancer patients undergoing radical prostatectomy and pelvic lymph node dissection.
详细描述
Study Phase: Phase II
Primary Objective:
To evaluate the diagnostic accuracy of the combined approach with β-probe and 68Ga-PSMA-11 PET/CT in the correct identification of lymph node metastases, in high-risk prostate cancer patients undergoing radical prostatectomy and pelvic lymph node dissection. The histopathological analysis of the surgical specimens will be considered the standard of reference and diagnostic accuracy will be evaluated in terms of sensitivity and specificity.
Secondary Objectives:
- the identification of the most appropriate tumor-to-background ratio (TBR) able to correctly locate the signal emitted by PSMA-positive lymph nodes compared with the signal derived by the background rumor.
- safety and toxicity analysis regarding the intraoperative application of the β-probe.
- the comparison between the signal detected by the β-probe and 68Ga-PSMA-11 PET/CT images.
- the correlation of the signal detected by the β-probe with the PSMA expression (PSMA staining) in lymph node metastases assessed by immuno-histochemical analysis on the surgical specimens
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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 proven prostate cancer
- •High-risk prostate cancer (T>T2c and/or PSA>20 and/or ISUP>3)
- •Patients suitable for radical prostatectomy + pelvic lymph node dissection
- •68Ga-PSMA-11 PET/CT performed within 4 weeks prior to surgery
- •PSMA positive pelvic lymph nodes detected at 68Ga-PSMA-11 PET/CT
- •Age >18 years old
- •Willing to sign informed consent
排除标准
- •Patient unfit for surgery
- •M1 stage (any M) detected at 68Ga-PSMA-11 PET/CT or other imaging modalities performed during diagnostic wok-up evaluation
- •Unable to tolerate PET scan
结局指标
主要结局
Sensitivity, specificity and positive predictive value in a per-region analysis
时间窗: March 2022 - March 2023
次要结局
- Comparison of β-probe measurements and 68Ga-PSMA-11 semi-quantitative parameters(March 2022 - March 2023)
- Comparison of β-probe intra-operatory measurements with ex-vivo ones.(March 2022 - March 2023)
- Comparison of β-probe measurements and PSMA expression assessed by immunohistochemical analysis (IHC).(May 2022 - December 2023)