The Role of Imaging Guided Surgery to Improve the Detection of Lymph Node Metastases in Prostate Cancer Patients Treated with Radical Prostatectomy and Extended Pelvic Lymph Node Dissection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Rate of lymph node invasion
研究概览
简要总结
The project aims at assessing the role of radio-guided surgery in the detection of lymph node invasion (LNI) in prostate cancer (PCa) patients undergoing radical prostatectomy (RP) by using an intraoperative gamma probe and a radioactive labelled PSMA ligand (99mTc-PSMA-I&S). We hypothesize that 99mTc-PSMA-I&S radio-guided surgery (99mTc-PSMA-RGS) might assist physicians in the identification of patients with LNI candidate for an extended pelvic lymph node dissection (ePLND). Overall, 100 men with a LNI risk >5% according to the Briganti nomogram will be submitted to 68Ga-PSMA PET/MRI followed by 99mTc-PSMA-RGS and ePLND. The aims are 1) to assess the safety and tolerability of 99mTc-PSMA-I&S; 2) to assess the accuracy of 99mTc-PSMA-RGS in the identification of LNI compared to available clinical tools and to molecular imaging (i.e., 68Ga-PSMA PET/MRI); 3) to assess whether 99mTc-PSMA-RGS would allow for the identification of positive nodes outside the standard ePLND template.
详细描述
Potential participants will be identified, screened and recruited by the Urologists working at the Department of Urology, IRCCS San Raffaele, Milan, Italy. A total of 100 patients affected by PCa with a risk of LNI >5% according to the Briganti nomogram and planned to receive RARP with an ePLND according to the European Association of Urology (EAU) guidelines will be identified and enrolled in the study.
The patient must personally sign and date the latest approved version of the Informed Consent Form (ICF) before any trial specific procedures are performed.
Written and verbal versions of the Patient Information and Informed Consent will be presented to the participants detailing no less than:
- The exact nature of the trial
- The surgical procedures
- The implications and constraints of the protocol
- The known side effects and any risks involved in taking part
- The clear statement that the participant is free to withdraw from the trial at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal.
The participant will be allowed as much time as wished to consider the information and the opportunity to question the Investigator, their GP or other independent parties to decide whether they will participate in the trial. Written Informed Consent will then be obtained by means of participant dated signature and dated signature of the person who presented and obtained the Informed Consent. The person who obtained the consent must be suitably qualified and experienced, and have been authorized to do so by the Principal Investigator.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients
- •Age between 18 and 80 years
- •Biopsy proven PCa with a LNI risk >5% according to the Briganti nomogram
- •Planned to receive a RARP with an ePLND
- •Able to understand and willing to sign a written informed consent document
排除标准
- •Receipt of neoadjuvant therapies
- •Inability to complete the imaging examinations according to the prospective protocol
- •Evidence of metastatic disease at conventional imaging before surgery
- •Evidence of clinical lymphadenopathies at conventional imaging before surgery
- •Life expectancy of less than 12 months
- •Previous chemotherapy
- •Previous brachytherapy or external beam radiotherapy
- •Unstable cardiovascular disease
- •Congestive Heart Failure (CHF)
- •Clinically significant hepatobiliary or renal disease
- •History of significant CNS injuries within 6 months
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
- •Medical history of allergic disease or reactions likely to be exacerbated by the IMPs used in this study or by any of the components of the radiotracers (99mTc-PSMA-I&S and 68Ga-PSMA)
- •Patients who received an experimental drug in the context of clinical trials within 30 days from the administration of the radiotracers in the current investigation or within 5 half-lives of the experimental drug itself
研究组 & 干预措施
Radioguided surgery
- 68Ga-PSMA PET/MRI acquisition
- 99mTc-PSMA-I&S intravenous injection the day before surgery
- 99mTc-PSMA-I&S SPECT/CT imaging
- 99mTc-PSMA-RGS to detect an increased count rate at the level of the nodal stations
- Robot-assisted ePLND followed by RP
- 99mTc-PSMA-RGS to detect an increased count rate in the prostatic fossa after removal of the primary tumor
- Histopathological examination
- Monitoring of adverse events and perioperative outcomes after surgery
干预措施: 99m-TC-PSMA-I&S (Drug)
结局指标
主要结局
Rate of lymph node invasion
时间窗: 12 weeks
Rate of LNI observed at final pathology after 99mTc-PSMA-RGS (histopathological evaluation of the lymph nodes)
次要结局
- Side effects(day 0)
- Nodal invasion outside the template(12 weeks)
- Postoperative complications(day 28 and day 84)