NCT04832958CompletedPhase 2
Imaging Guided Surgery to Improve the Detection of Lymph Node Metastases in Prostate Cancer Patients
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
Source: ClinicalTrials.gov · Last updated 14 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 81 (actual)
- First submitted
- 3 Apr 2021
- Start date
- May 2021
- Primary completion date
- Nov 2024
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Prostate cancer
- NCT number
- NCT04832958
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 81
- From May 2021 to the primary completion date, Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of neoadjuvant therapies
- Evidence of clinical lymphadenopathies at conventional imaging before surgery
- Previous chemotherapy
- Previous brachytherapy or external beam radiotherapy
- 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
Other illness
- Evidence of metastatic disease at conventional imaging before surgery
- 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)
Other
- Inability to complete the imaging examinations according to the prospective protocol
- Life expectancy of less than 12 months
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.