A study looking at a new PET scan tracer for men with prostate cancer (FDHT study)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Prostate cancer

Status:

Closed

Phase:

Other

This study is looking at a new radioactive injection (tracer) that you have before a PET scan to look for areas of prostate cancer.

It is for men with prostate cancer that has grown or spread to other parts of the body (progressive prostate cancer).

More about this trial

PET scans are a common cancer test. You might have one to: 

  • diagnose cancer
  • show if the cancer has spread to other parts of the body
  • find out how well treatment is working

Before you have a PET scan, you have an injection with a small amount of a radioactive drug called a tracer. The tracer is taken up by the cancer cells, which then show up on the scan. 

In this study, researchers are looking at a new tracer called 18F-Dihydro-Testosterone ([18F]-FDHT). They think that it can show up prostate cancer cells better. 

Everyone taking part in this study have up to 3 PET scans using the new tracer ([18F]-FDHT PET scan) and up to 3 MRI scans.

The main aims of this study are to:  

  • see where the tracer goes in your body
  • find out how much of the tracer is taken up by prostate cancer cells before and after treatment

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 

Who can take part

You may be able to join this study if you are a man and all of the following apply. 

  • You have prostate cancer that has grown or spread to other parts of the body or your PSA level Open a glossary item has increased in the last 2 to 3 blood tests 
  • You have at least 1 area of cancer that is getting worse (progressive disease) and that can be seen and measured on a scan
  • You have satisfactory blood tests results 
  • You are at least 18 years old 

Who can’t take part

You cannot join this study if you have had a severe allergic reaction to a [18F]-FDHT PET scan in the past. 

Trial design

This is an international study. Researchers hope that around 105 people worldwide will take part. This includes around 30 people going to the Royal Marsden Hospital in Sutton.  

You go to the nuclear medicine department to have the [18F]-FDHT PET scans:

  • before treatment
  • 28 days after treatment
  • if your cancer gets worse (you don’t have to agree to this if you don’t want to)

You complete a questionnaire and have a small tube called a cannula put into a vein in each one of your arms. The research team will use one cannula to inject the new tracer and the other to take blood samples during the scan. 

You have a CT scan first. After this, the research team injects the tracer into the cannula. You then have the [18F]-FDHT PET scan. It takes about 2 hours in total.  

You have blood samples taken during each [18F]-FDHT PET scan. The researchers want to look at what happens to the tracer in your body.   

You also have MRI scans of your whole body. You have this before treatment, 28 days after the end of treatment and if your cancer gets worse. It takes about 45 minutes each time. 

Hospital visits

You see a doctor and have some tests before taking part. These tests include: 

  • physical examination
  • blood tests

You go to the Royal Marsden hospital in Sutton to have the scans. There can be up to 6 visits (3 visits to the nuclear medicine department and 3 visits to the MRI department). 

After the scans, you see the trial doctor every 3 months for a year. This is part of your routine follow up Open a glossary item

Side effects

The study team will monitor you during and after you have the scans. You will have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.

PET scans are very safe and the team doesn’t think you will have any side effects from it. 

A number of people have had the [18F]-FDHT tracer as part of other clinical trials. The side effects of the new tracer are:

  • pain at the injection site
  • taste changes
  • allergic reaction

We have information about having a PET scan and MRI scan.  

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Wim Oyen 

Supported by

The Royal Marsden Hospital NHS Foundation Trust
Movember Foundation
NIHR Clinical Research Network: Cancer

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13083

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Keith took part in a trial looking into hormone therapy

A picture of Keith

"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”

Last reviewed:

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