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

PSMA RGS

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.

2021-05-15

2024-11-15

2024-11-15

Recruiting

Early phase I

100

Inclusion Criteria: * 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 Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-02-21