A trial looking at high intensity focused ultrasound to treat only areas of the prostate gland that contain cancer (INDEX)

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:

Phase 2

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.

More about this trial

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

How well it works to control prostate cancer
What side effects men have after this treatment

Who can enter

You may be able to join this trial if all of the following apply. You

Have had samples of tissue (biopsies ) from your prostate that shows all of your cancer is on 1 side of your prostate, or your cancer is on both sides of the prostate but on one side the cancer is no more than 3mm across and has a Gleason score of no more than 3+3
Have cancer that is still contained inside the prostate gland (stages T1 to T2c). If a scan shows that the cancer has just broken through the covering of the prostate (stage T3a) you can still take part
Have a maximum Gleason score of no higher than 4+3
Have a PSA blood test result of 20 or less
Have a life expectancy of at least 10 years
Are able to understand information about the trial in English

You cannot join this trial if any of these apply. You

Have had radiotherapy to the area between your hip bones (pelvis)
Have had hormone therapy for prostate cancer in the last 6 months
Have had a scan that shows your cancer has spread to your lymph nodes or other parts of your body
Would not be able to have an ultrasound probe put into your back passage to scan your prostate (transrectal ultrasound) for any reason (you can check this with your doctor)
Have had HIFU, cryosurgery, heat treatment or microwave treatment to the prostate in the past
Have had a type of surgery called a transurethral resection of prostate (TURP) in the last 6 weeks
Would not be fit enough to have a general anaesthetic
Are not able to have an MRI scan for any reason, for example you have some metal in your body, or a pacemaker , or cannot cope with being in small spaces
Have problems with your kidneys that means they may not get rid of the dye used for the MRI scan (you can check this with your doctor)

Trial design

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 enema Open a glossary item 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.

Hospital visits

Before you join the trial you will see the doctor and have some tests. These tests include

A PSA blood test
A physical examination

If you have not already had them, you will also have

An MRI scan
A prostate biopsy taken through the skin between your testicles and back passage (a template or targeted biopsy).

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 local anaesthetic Open a glossary item 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.

Side effects

Complications from HIFU include

Symptoms related to passing urine (going a lot, needing to go urgently, having difficult passing urine) in the first 2 to 3 months after treatment
Urine infection
Narrowing of the tube that carries urine from the bladder (the urethra), some people may need to have a further operation if they have this
Not producing semen during ejaculation (a ‘dry climax’) or producing less semen
Reduced fertility
Infection of the tubes surrounding the testicles (epididymitis)
Not being able to get an erection (impotence)
Leaking of urine, needing pads
An abnormal connection between the back passage and the tube carrying urine from the bladder (recto urethral fistula)

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.