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

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.

Timeline

Start

2021-05-15

Primary completion

2024-11-15

Completion

2024-11-15

Publications

• Gandaglia G, Mazzone E, Stabile A, Pellegrino A, Cucchiara V, Barletta F, Scuderi S, Robesti D, Leni R, Samanes Gajate AM, Picchio M, Gianolli L, Brembilla G, De Cobelli F, van Oosterom MN, van Leeuwen FWB, Montorsi F, Briganti A. Prostate-specific membrane antigen Radioguided Surgery to Detect Nodal Metastases in Primary Prostate Cancer Patients Undergoing Robot-assisted Radical Prostatectomy and Extended Pelvic Lymph Node Dissection: Results of a Planned Interim Analysis of a Prospective Phase 2 Study. Eur Urol. 2022 Oct;82(4):411-418. doi: 10.1016/j.eururo.2022.06.002. Epub 2022 Jul 22.

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Indications