
"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at using high frequency sound waves (high intensity focused ultrasound or HIFU) to treat areas of cancer in the prostate. The trial is for men with prostate cancer that is medium to high risk of spreading, but hasn’t spread beyond the prostate.
If you have prostate cancer that has not spread outside the prostate gland, you can choose from a number of treatments. These include radiotherapy and surgery to treat the whole gland. HIFU may also be offered in some centres. Or, you can decide to let your doctor carefully monitor your cancer, and only treat it if it gets worse. This is called active surveillance.
Having treatment to the whole prostate can mean greater certainty that your cancer is controlled. But these treatments can also affect sexual function, bladder control, and cause bowel problems. If you choose active surveillance, you don’t have the treatment side effects, but need to live with the risk of your cancer possibly getting worse in the future. You will also need to have regular blood tests and biopsies.
In this trial, researchers are looking at using HIFU to treat only the areas within the prostate gland that contain cancer. This is called focal therapy. They will treat areas of cancer that would be at risk of spreading if left untreated. Treating less of the prostate should mean a lower risk of side effects. Small areas of cancer that are thought to be at very low risk of spreading are not treated. These can be closely monitored.
If successful, this could become a standard choice of treatment for men with cancer that is completely within the prostate gland. The researchers hope that this trial will help them find out
You may be able to join this trial if all of the following apply. You
You cannot join this trial if any of these apply. You
The trial team aims to treat 354 men as part of the trial. Everyone will have HIFU and a series of tests over a 2 year period, to monitor how well the treatment is working.
On the morning of your HIFU treatment you will have an to clear your back passage. This allows the team to have a clearer view with the ultrasound scan during your treatment. You will have a general anaesthetic to put you to sleep. Then the team will put the HIFU probe into your back passage. The treatment usually takes between 1½ to 2 hours. You should be able to go home later that same day, as long as you are well after the procedure and have someone that can stay with you overnight.
Because the treatment can cause the prostate to swell, the team will also put a catheter through the tube which carries urine from your bladder to the outside of your body (urethra), to drain your urine. This is a called a ‘urethral catheter’ and it stays in place for 1 to 2 weeks. Before you go home, the team will give you antibiotics and mild painkillers, and show you how to care for the catheter.
You will fill out questionnaires before you start the trial, and regularly throughout the trial. The questionnaires will ask about any side effects you have had and about how you have been feeling. It will include questions of a personal nature about your sexual function and any problems with passing urine. This is called a quality of life study.
With your permission the team will collect information about your healthcare 5 years and 10 years after treatment. To collect the information a member of the team can phone you or they can take it from your medical records. You don't need to go to the clinic.
Before you join the trial you will see the doctor and have some tests. These tests include
If you have not already had them, you will also have
You will go to hospital on a different day to have the HIFU.
You will have the catheter removed 1 or 2 weeks later.
After having HIFU, you will see the doctor, have a blood test and urine test at 3, 6, 9, 12, 18 and 24 months. Some of these appointments will be carried out over the phone. In this case you can have the PSA and urine test at your GP surgery. And you can fill out the questionnaires at home and return them to the team in pre-paid envelopes.
At the 12 month appointment, you will also have another MRI scan and more targeted prostate biopsies. You have a and the doctor takes the biopsies through the back passage using an ultrasound scan. The biopsies will take about 20 minutes, and you should not need to stay in hospital. You will see the doctor to get these results when they are ready.
Complications from HIFU include
The trial team will talk to you about all possible complications of HIFU before you agree to take part in this trial.
We have more information about HIFU.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Prof Hashim Uddin Ahmed
NIHR Clinical Research Network: Cancer
Sonacare Medical
University College London (UCL)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”