PET-Guided Navigation with Electromagnetic Tracking during PSMA-RadioGuided Surgery: Innovative Bimodal Detection of Nodal Metastases in Prostate Cancer Patients
Prostate cancer can spread to nearby lymph nodes, which are small glands that help fight infection. Finding and removing these tiny bits of cancer during an operation can be tricky. This Phase 2 clinical trial tests a new navigation system designed to guide surgeons in real time. Before surgery, patients receive an injection of a special tracer liquid called [99mTc]PSMA I&S. This liquid safely attaches to prostate cancer cells and gives off a weak signal. During surgery, doctors use electromagnetic tracking—similar to a satellite navigation system—to follow the signal directly to affected lymph nodes and remove them. The main goal is to see whether this technique leads to a successful outcome, measured by very low PSA levels in the blood six weeks after surgery. Researchers will also monitor the safety and accuracy of the tracking device and tracer.
At a glance
What is this study about?
When prostate cancer spreads, it often moves first to the surrounding lymph nodes. These tiny glands act as filters in the body, but when cancer cells settle inside them, they can be very difficult to see with the naked eye. Leaving even small traces behind can cause cancer to return, requiring further treatment later on.
This study tests an innovative way to guide surgeons during prostate cancer operations. Patients receive a small, safe injection of a tracer that highlights prostate cancer cells. In the operating theatre, surgeons then use an electromagnetic tracking system that works like a GPS. This helps them pinpoint and remove affected lymph nodes with great accuracy, while protecting healthy surrounding tissue.
Doctors want to find out whether this high-tech guidance improves patient outcomes. The main test is checking the level of prostate-specific antigen (PSA) in the blood six weeks after the operation. A very low reading (under 0.1 ng/mL) suggests that the surgery successfully cleared the cancer.
By testing how reliable and safe this equipment is, researchers hope to give surgeons better tools to treat prostate cancer completely on the first attempt.
Key takeaways
- Tests a GPS-style tracking system to guide surgeons during prostate cancer surgery.
- Uses a special tracer injection to highlight cancer cells in the lymph nodes.
- Aiming to achieve very low PSA blood levels (under 0.1 ng/mL) six weeks after surgery.
- Open to men aged 18 and older who are already scheduled for prostate surgery.
- Participation does not replace your operation, but adds extra navigation to it.
Who may be eligible?
This study is open to adult men aged 18 and over who have been diagnosed with prostate cancer and are already scheduled to have surgery to remove their prostate and lymph nodes.
Because the study focuses on tracking cancer spread, doctors will review your previous scans to see if this navigation method is suitable for your specific operation. Men must be well enough to undergo general surgery.
You may not be able to take part if you have certain medical conditions or allergies that make using the tracer liquid unsafe. Your care team will review all of your health details before inviting you to join.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am a man aged 18 or older.
- I have been diagnosed with prostate cancer.
- I am scheduled to have surgery to remove my prostate and lymph nodes.
- I am well enough to undergo general anaesthesia and surgery.
- I am able to attend a follow-up blood test six weeks after my operation.
What does participation involve?
If you take part, you will receive an injection of the tracer liquid [99mTc]PSMA I&S shortly before your scheduled prostate surgery. You will then have your operation, during which the surgical team will use the tracking tools to find and remove target lymph nodes. After surgery, your recovery in the hospital will be monitored just like standard care, with extra checks for any side effects from the tracer or tracking device. You will attend a follow-up appointment about six weeks later for a routine PSA blood test. In total, taking part lasts from your pre-surgery preparation until your six-week follow-up visit.
Potential risks and benefits
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Common questions
Will the radioactive tracer make me dangerous to others?
No. The tracer uses a very low dose of radiation that fades quickly and leaves your body naturally through your urine within a day or two.
Is this a new type of surgery?
No, your planned surgery remains the same. The trial simply adds a guidance tool to help the surgeon see and remove affected tissue more clearly.
What does a low PSA level at six weeks mean?
PSA is a protein made by the prostate. After the prostate is removed, a very low PSA level (under 0.1 ng/mL) indicates that the cancer has likely been cleared.
Will taking part delay my planned operation?
No. The tracer injection and navigation are timed to fit smoothly into your normal hospital surgical schedule.
What happens if I change my mind?
You are free to leave the study at any time. Your medical team will simply carry out your surgery using standard NHS methods.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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