Imaging Guided Surgery to Improve the Detection of Lymph Node Metastases in Prostate Cancer Patients

NCT04832958 PHASE2 COMPLETED

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.

Details

Lead sponsor	IRCCS San Raffaele
Phase	PHASE2
Status	COMPLETED
Enrolment	81
Start date	Sat May 15 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Prostate Cancer

Interventions

• 99m-TC-PSMA-I&S

Countries

Italy