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

You can enter this trial if you have prostate cancer and you have had biopsies that show any of the following

• All of the cancer is on one side of the prostate
• You have cancer 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
• You have cancer on both sides of the prostate that measures 3mm or less and has a Gleason score of 3+3 (‘clinically unimportant cancer’), but one side of the prostate has more cancer than the other

To enter this trial, you must also have all of the following

• Cancer that is still contained inside the prostate gland (stages T1 to T2c) - if a scan has shown that the cancer has just broken through the covering of the prostate (stage T3a) you can still take part
• A maximum Gleason score of no higher than 4+3
• A PSA reading of 15 or less
• A life expectancy of at least 10 years
• The ability to understand information about the trial in English

You cannot enter this trial if you

• Have had radiotherapy
• Have had hormone therapy for prostate cancer in the last 12 months
• Have had a scan that shows your cancer 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
• Are allergic to latex
• 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 months
• 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 a up build up of a significant amount of calcium, or lumps called cysts in your prostate, which would affect HIFU treatment – an ultrasound scan will show this
• Your kidneys do not work well enough to get rid of the dye used for the MRI scan – you can check this with your doctor

This trial will recruit around 150 men. Everyone will have HIFU and a series of tests and scans over a 3 year period, to monitor how well the treatment is working.

On the morning of your HIFU treatment you will have an enema 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 1 ½ to 2 hours. You should be able to go home about 4 hours later, as long as someone can stay with you overnight.

Because the treatment can cause the prostate to swell, the team will also put a catheter through the skin of your lower tummy and into your bladder, to drain your urine. This is a called a ‘supra pubic catheter’, and it stays in place for up to 2 weeks. Before you go home, the team will give you antibiotics and mild pain killers, and show you how to care for the catheter.

You will also fill out a questionnaire before you start the trial, and regularly throughout the trial. The questionnaire 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.

The team will also ask if you would be willing to give extra blood and urine samples. You give up to 6 teaspoons of blood on three occasions during the trial. These extra tests will be used to find out more about prostate cancer. They will not change your treatment plan in any way. You do not have to have these extra tests if you don’t want to. You can still take part in the trial.

At some trial centres you will also be asked to have a new type of ultrasound scan called Histoscanning. They would like to see how good this scan is at finding cancers in the prostate. They will compare results with your MRI scan and some of the trial biopsies. Histoscanning is very similar to a trans rectal ultrasound scan. Having the scan in this trial will not affect your treatment plan in any way.

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 transperineal template biopsy) – you will have a general anaesthetic for this

One or 2 weeks after HIFU, you have your catheter removed and some people will have another MRI scan.

You will see the doctor, have a blood test and fill out a questionnaire after 6 weeks, and then 3, 6, 9, 12, 18, 24, 30 and 36 months after HIFU.

If your trial hospital is happy with this, some of these visits can be replaced with telephone conversations with the trial team and blood tests with your GP. In this case, you would fill out the questionnaires at home and return them to the team in pre paid envelopes.

You will also have blood tests taken at your GP surgery at 15, 21, 27 and 33 months after HIFU.

At the 12 month appointment, you will also have another MRI scan and more biopsies under local anaesthetic, using an ultrasound scan of your prostate through the back passage. The biopsies will take about 20 minutes, and you should not need to stay in hospital. You will see the doctor for these results when they are ready.

At the 36 month appointment, you will have another MRI scan, and another template biopsy under general anaesthetic.

If your centre is carrying out HistoScanning, you have these

• Just before your template biopsies, or just before HIFU
• At the 12 month visit, just before your biopsies
• At 36 months, just before your last biopsies

You then see the trial team for the last time 38 months after your treatment. They will discuss the results of your biopsies and MRI scan.

If you agree to the extra blood tests, you will have these at your first visit (before treatment), and again at 12 months and 36 months after HIFU treatment.

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)