RecruitingOBSERVATIONAL

A Prospective, Bicentric Evaluation of Fluciclovine PET-imaging in Patients with Prior Negative or Inconclusive PSMA-ligand PET

The REFINE study is investigating a special type of scan, called a fluciclovine PET/CT, to help doctors find prostate cancer that has returned. This is especially useful for men who have had treatment for prostate cancer in the past and whose previous scans (known as PSMA PET/CT scans) didn't clearly show if the cancer was back, or where it was located. The study aims to see how well the fluciclovine PET/CT scan works in real-life situations. Participants will have this scan and then be followed for 12 months to see how accurate the scan results were. The goal is to improve how doctors detect prostate cancer recurrence so they can make better decisions about treatment.

At a glance

Status

Recruiting

Sponsor

Technical University of Munich

Enrolment target

Start

01 Mar 2025

Estimated completion

01 Dec 2027

Biochemical Recurrence of Malignant Neoplasm of Prostate

What is this study about?

When prostate cancer comes back after treatment, doctors call this 'biochemical recurrence.' Often, the first step to find out where the cancer might be is a special scan. This study is testing a new type of scan called a fluciclovine PET/CT. It's particularly for men who have had previous scans (called PSMA PET/CT scans) that were unable to clearly show if the cancer had returned, or precisely where it was located in the body. The aim is to see if this new fluciclovine scan can give doctors a clearer picture.

The researchers want to understand how well the fluciclovine PET/CT scan works in real situations. They are enrolling men who have already had treatment for prostate cancer, and whose PSA levels (a blood test that can indicate prostate cancer) are rising again, suggesting the cancer might be back. By comparing the results of the fluciclovine scan with other information gathered over time, the doctors hope to learn if this new scan is better at finding the returning cancer.

This study is important because finding prostate cancer recurrence early and accurately can help doctors decide on the best next steps for treatment. If the cancer can be pinpointed more precisely, it might lead to more targeted and effective treatment plans, potentially improving patient outcomes.

Key takeaways

This study explores a new scan (fluciclovine PET/CT) for recurrent prostate cancer.
It's for men whose previous scans (PSMA PET/CT) were unclear.
The goal is to improve how doctors find returning prostate cancer.
Participation involves having the scan and being followed for 12 months.
No new medications are given; it evaluates a diagnostic scan.
It could help doctors make more informed treatment decisions in the future.

Who may be eligible?

This study is looking for men aged 18 or older who have been treated for prostate cancer and are now showing signs that the cancer might be returning. This means your PSA levels are rising after your initial treatment, such as surgery (radical prostatectomy) or radiotherapy, or a combination of treatments.

Specifically, if you've had surgery, your PSA needs to be at a certain level and confirmed by a second test. If you've had radiotherapy, your PSA needs to have risen by a specific amount from its lowest point. Also, previous scans to find the returning cancer (PSMA PET/CT) must have been either negative or unclear.

You would not be able to join if you have any other health conditions that might make it hard to take part in the study or if you're currently receiving certain hormone therapies for prostate cancer (like ADT) or have had them within the last three months.

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.

Are you a man aged 18 or older?
Have you had treatment for prostate cancer (like surgery or radiotherapy)?
Are your PSA levels rising after your treatment, indicating the cancer might have returned?
Were your previous scans (PSMA PET/CT) unable to clearly show if or where the cancer had returned?
Have you not received certain hormone therapies for prostate cancer in the last 3 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a fluciclovine PET/CT scan as part of your usual medical care. The images from your scan will then be looked at by different specialist doctors to ensure a thorough review. You will be followed up for a total of 12 months.

During this time, the study team will gather information about your health. At one month after your scan, your doctor will be asked about any changes to your treatment plan. Throughout the 12 months, the team will collect information such as results from any other scans you have, your PSA levels, how your treatment is working, and any biopsy results if applicable. All of this information helps the researchers understand the accuracy of the fluciclovine scan.

Potential risks and benefits

Taking part in this study may offer some benefits, such as contributing to scientific understanding that could help future patients with prostate cancer. The fluciclovine PET/CT scan you receive is part of your normal care, so you wouldn't be undergoing extra procedures solely for the study. However, as with any medical procedure, there are minor risks associated with the scan itself, which your doctor can explain. You are also free to withdraw from the study at any time without it affecting your medical care.

Locations (2)

University Hospital Augsburg
Verified postcode
Augsburg, Germany· Not yet recruiting
TUM University Hospital
Verified postcode
Munich, Germany· Recruiting

Common questions

What is a fluciclovine PET/CT scan?

It's a special imaging test that uses a small amount of radioactive material to help doctors find prostate cancer cells in the body, especially when the cancer has returned.

Why is this scan being studied?

It's being studied to see if it can better detect prostate cancer that has come back, particularly when other scans haven't been clear enough to locate it.

Will I get any new medicine in this study?

No, this study is about evaluating a scan, not new medications. You will continue with your standard medical care as advised by your doctor.

How long will I be involved in the study?

You will be followed for a total of 12 months after your fluciclovine PET/CT scan.

What if my PSA levels are rising but I'm on hormone therapy?

You would generally not be able to join this study if you are currently on certain hormone therapies or have been within the last three months, as this could affect the study results.

How to find out more

Matthias Eiber, MD

matthias.eiber@tum.de +49 89 4140 0 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.