2026-526915-12-00Not yet recruitingPhase 2
PET-Guided Navigation with Electromagnetic Tracking during PSMA-RadioGuided Surgery: Innovative Bimodal Detection of Nodal Metastases in Prostate Cancer Patients
Source: EU CTIS (euclinicaltrials.eu) · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 30 Jun 2026
- Start date
- 1 Oct 2026
- Lead sponsor
- Ospedale San Raffaele S.r.l.
- Diseases
- Prostate cancer
- EU CT number
- 2026-526915-12-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 54
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale San Raffaele S.r.l. | Milan | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.