Patients with prostate cancer (PCa) who are candidate to undergo surgical treatment with robot-assisted radical prostatectomy with a risk of lymph nodal invasion > 5% according to preoperative data MedDRA version: 21.1 Level: LLT Classification code 10026389 Term: Malignant neoplasm of prostate System Organ Class: 100000004864
Conditions
Interventions
Product Name: 99mTc-PSMA-I&S
Product Code: [99mTc-PSMA-I&S]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PSMA I&S (99mTc-MAS3-y-nal-k(Sub-KuE))
Current Sponsor code: 99mTc-PSMA I&S
Sponsors
OSPEDALE SAN RAFFAELE
Eligibility
Sex/Gender
Male
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to improve clinicians’ ability to identify LNI in PCa patients undergoing RARP with an ePLND and to assess the role of 99mTc-PSMA-I&S in this setting.;Secondary Objective: 1.To optimize the synthesis of 99mTc-PSMA-I&S 2.To assess the safety and tolerability of the administration of 99mTc-PSMA-I&S 3.To assess the diagnostic accuracy of 99mTc-PSMA-RGS in the identification of LNI in men at higher risk for LNI and to compare its predictive accuracy to preoperative 68Ga-PSMA PET/MRI and to available predictive tools such as the Briganti nomogram. 4.To assess whether 99mTc-PSMA-RGS would allow for the identification of positive nodes outside the anatomically defined ePLND template, which includes the internal and external iliac as well as the obturator lymphatic landing sites.;Primary end point(s): Rate of LNI observed at final pathology after 99mTc-PSMA-RGS (namely, histopathological evaluation of the lymph nodes done by a dedicated high-volume uro-pathologists, the results are typically available 10 days after surgery).;Timepoint(s) of evaluation of this end point: 10 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Side effects associated with the administration of 99mTC-PSMA-I&S; Rate of intraoperative complications associated with 99mTc-PSMA-RGS assessed at visit 2; Rate of postoperative complications associated with 99mTc-PSMA-RGS assessed; Rate of LNI observed at final pathology in nodes outside the extended nodal dissection template detected only by 99mTc-PSMA-RGS;Timepoint(s) of evaluation of this end point: Within 84 days; Day 28; Day 84; Day 10 | — |
Countries
Italy
Contacts
Public ContactUrologia
Ospedale San Raffaele
Outcome results
None listed