Imaging Guided Surgery to Improve the Detection of Lymph Node Metastases in Prostate Cancer Patients
Status:
Recruiting
Trial end date:
2024-11-15
Target enrollment:
Participant gender:
Summary
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.