AuthorisedTherapeutic use (Phase IV)Interventional

ECETEP : Pilot study evaluating PSMA positron emission tomography for monitoring clinically significant prostate cancer after focal HIFU treatment

This clinical trial is testing a modern type of imaging called a PSMA PET scan in men who have had targeted ultrasound treatment (HIFU) for prostate cancer. HIFU destroys cancer cells in the prostate using sound waves. After this treatment, doctors need reliable ways to check that the cancer has not come back. In this study, participants receive a special dye called piflufolastat (18F) through a vein. This dye attaches to prostate cancer cells and lights them up on a PET scan. Doctors will compare the results of the scan with standard checks, such as an MRI and small tissue samples (biopsies), taken one year after treatment. The main aim is to see if PSMA PET scans are accurate enough to help monitor men safely and spot any returning cancer as early as possible.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Centre Hospitalier Universitaire De Toulouse

Enrolment target

Start

25 Jun 2026

prostate cancer

What is this study about?

Prostate cancer is the most common cancer in men in the UK. When the cancer is caught early and stays inside the prostate, doctors can sometimes treat just the diseased area rather than the whole gland. One way to do this is with focal HIFU (High-Intensity Focused Ultrasound), which uses concentrated sound waves to heat and destroy cancer cells while protecting healthy tissue around them.

After HIFU treatment, it is vital to keep a close eye on the prostate to make sure the cancer has not returned. Currently, doctors usually rely on blood tests, MRI scans, and biopsies. However, it can sometimes be difficult on standard scans to tell the difference between harmless scar tissue from the HIFU treatment and cancer cells that may have come back.

This pilot study tests an advanced imaging method called a PSMA PET scan. Before the scan, patients receive an injection of a tracking substance called piflufolastat (18F). This tracker sticks to a specific protein found on the surface of prostate cancer cells, making them glow on the scan.

By comparing these scans with tissue samples taken one year after treatment, the researchers hope to discover how dependable PSMA PET scans are. If the scans prove accurate, they could give doctors a clearer way to monitor patients, helping them catch any returning cancer sooner and avoid unnecessary invasive procedures in the future.

Key takeaways

Tests how well a PSMA PET scan spots returning cancer after focal HIFU treatment.
A harmless tracking dye is used to highlight prostate cancer cells on the scanner.
Scan results are checked against standard prostate biopsies at the one-year mark.
Open to men who have had targeted HIFU therapy for prostate cancer.
Participation is voluntary and does not interrupt your normal NHS treatment plan.

Who may be eligible?

This study is open to men of any age who have been diagnosed with prostate cancer and have received targeted ultrasound treatment (focal HIFU). Because the study specifically looks at how clear the scans are after this exact treatment, you must have had focal HIFU rather than surgery to remove the entire prostate or full-gland radiotherapy.

Participants must be willing to attend follow-up visits, undergo the specialised PET scan, and have standard safety checks. Doctors will check your medical history to ensure that you are fit to have the imaging dye and the scan.

If you have had other treatments that might interfere with the scan results, or if your kidneys cannot safely process the imaging dye, this study may not be suitable for you. Your hospital care team can confirm whether you meet all the safety rules.

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 male.
I have been diagnosed with localized prostate cancer.
I have had, or am scheduled to have, focal HIFU treatment.
I am able to attend follow-up visits, including scans and checks, around one year after treatment.
I am able to lie still on a flat scanner bed for 20 to 30 minutes.

Answer every question to see your result.

What does participation involve?

Taking part in this study takes place over the course of about one year following your HIFU procedure. During the study, you will have planned clinic visits where the team will monitor your recovery.

Around one year after your treatment, you will attend a hospital imaging appointment. A nurse or doctor will place a small needle (cannula) into a vein in your arm to give you a small, safe injection of the tracking dye (piflufolastat 18F). You will wait quietly for a short time to allow the dye to travel through your body, and then you will lie flat inside the PET scanner while it takes pictures of your pelvis.

As part of your standard follow-up checks, you will also have an MRI scan and routine prostate biopsies (where tiny tissue samples are taken to check for cancer cells under a microscope). Researchers will compare the pictures from your PET scan with these biopsy results. No extra experimental medicines are given, and your total direct involvement in study scans will usually take just a few hours around your one-year check-up.

Potential risks and benefits

Taking part may not help you directly, but having these detailed scans means your prostate is monitored very carefully during your recovery. The results will also help doctors design better, less invasive ways to monitor men with prostate cancer in the future. The risks are generally low. The tracking dye carries a very small amount of radiation, similar to other standard medical scans, and allergic reactions to it are rare. If you have a biopsy as part of your standard follow-up, this can cause brief soreness, light bleeding, or a small risk of infection. Taking part is completely voluntary, and you can change your mind and leave the trial at any time without it affecting your standard NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is a PSMA PET scan?

It is a scan that uses a tiny, safe amount of a radioactive tracker to find a protein called PSMA, which is often found in large amounts on prostate cancer cells. This helps doctors see any cancer cells clearly on the screen.

Will having this scan make me radioactive?

The tracking dye contains a very low amount of radiation that naturally leaves your body through your urine within a few hours. Drinking plenty of water after your scan helps flush it out quickly.

Does this trial replace my normal cancer treatment?

No. This study focuses on how best to check your prostate after your HIFU treatment has already taken place. It works alongside your regular care.

Does the scan hurt?

The scan itself is completely painless. You will feel a quick scratch when the small tube (cannula) is inserted into your arm for the dye, and you will need to lie still on a padded scanning bed for about 20 to 30 minutes.

What happens if the scan finds something?

If your scan shows signs that cancer may be present, your medical team will discuss the findings with you right away and help you choose the best next steps for your care.