PET-guided navigation during PSMA-radioguided surgery to find prostate cancer in lymph nodes
Tests combined PET navigation and PSMA-guided surgery in men with prostate cancer lymph node spread.
Key facts
- Who runs it
- Ospedale San Raffaele S.r.l.
- Where
- Milan, ItalySee the site
- Trial code
- Registry title
- PET-Guided Navigation with Electromagnetic Tracking during PSMA-RadioGuided Surgery: Innovative Bimodal Detection of Nodal Metastases in Prostate Cancer Patients
- Status
- Not yet recruiting
- Phase
- Phase 2
- People taking part
- 54 people, planned
- Started
- 1 Oct 2026
- Expected to end
- 31 Aug 2029
- Type of study
- Interventional
- Record updated
- 19 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has spread to nearby lymph nodes but not to distant sites, and who can have robot-assisted prostate surgery with lymph node removal.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Newly diagnosed prostate cancer, or cancer that came back in a few places, with spread to nearby lymph nodes (miN1) but no distant spread (M0). The planned operation is robot-assisted prostate removal (RARP) with extended pelvic lymph node removal (ePLND) or sentinel lymph node removal (SLND).
- Earlier treatment
- People who have had hormone treatment for prostate cancer (before or after surgery, previous or ongoing) cannot join.
Main reasons for not taking part
- Hormone treatment for prostate cancer, before, after, previous or ongoing
- Cannot complete the imaging protocol
- Cancer spread to distant sites (miM1) on the PSMA-PET scan
- Reasons that make the planned surgery unsafe, including robot-assisted surgery
- A cardiac pacemaker that can interfere with the navigation system
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- Male participants who are at least 18 years of age on the day of signing informed consent - Ability to provide written informed consent - Newly diagnosed miN1M0 Pca or oligorecurrent miN1M0 PCa - Eligibility for RARP and ePLND or SPLND
Who cannot take part
- Neoadjuvant or adjuvant, previous or concomitant hormonal treatment for prostate cancer - Inability to complete the imaging protocol - miM1 at PSMA-PET - Contraindications to the planned surgical procedure, including robot-assisted surgery - Cardiac pacemaker which can cause interference with the navigation system
Where in Italy
- Ospedale San Raffaele S.r.l.Milan, ItalyNot yet recruiting
About the trial
What the trial wants to find out
To evaluate the role of PSMA-PET-guided navigation with electromagnetic tracking combined with PSMA-RGS to improve bCR rate (PSA <0.1 ng/mL at 6 weeks after surgery) in miN1 PCa patients with primary or recurrent disease undergoing RARP + ePLND or SLND.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- PET-Guided Navigation with Electromagnetic Tracking during PSMA-RadioGuided Surgery: Innovative Bimodal Detection of Nodal Metastases in Prostate Cancer Patients
- Plain-language title
- PET-guided navigation during PSMA-radioguided surgery to find prostate cancer in lymph nodesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 19 October 2026