A trial looking at using high intensity focused ultrasound (HIFU) to delay further treatment for prostate cancer

Please note this trial is no longer recruiting patients.

This trial is looking at using high intensity focused ultrasound (HIFU) to delay further treatment for prostate cancer by treating the largest area of cancer in the prostate gland.

The commonest treatments for early prostate cancer are surgery, radiotherapy and hormone therapy. All of these treat the whole prostate, but they have side effects that can severely affect quality of life. These side effects include leakage of urine, loss of erection and problems with the back passage. But we know from research that treating one area of the prostate can reduce these side effects and improve quality of life.

There is often more than one area of cancer in the prostate. We know from research that it is the largest area of cancer that is the most likely to spread. Doctors think that treating the largest area can delay the spread of the cancer and the need to have surgery, radiotherapy or hormone therapy. Men with early prostate cancer may then have a better quality of life for longer.

High intensity ultrasound beams can kill cancer cells if the beam is focused directly on to them. This treatment is called high intensity focused ultrasound (HIFU). We know from research that this treatment can help men with prostate cancer.

Treatment with HIFU may delay the need for more intensive treatment and therefore also delay the onset of side effects from further treatment.

The aim of this trial is to find out if treating the largest area of cancer in the prostate gland with HIFU can delay the need for further treatment. And to see what the side effects are.

Recruitment

Start 20/07/2009

End 01/11/2010

Phase

Phase 2

Who can enter

You can enter this trial if you

Have been diagnosed with stage 1, 2 or 3 prostate cancer
Have a Gleason score of 8 or less
Have a PSA level of 20 or less
Are well enough for a general anaesthetic

You cannot enter this trial if you

Have cancer that has spread outside the prostate
Have had hormone therapy in the last 12 months
Have had radiotherapy for prostate cancer before
Have had an operation called transurethral resection of the prostate (TURP) in the last 2 years
Have had HIFU, cryosurgery, heat treatment or microwave treatment before
Have had rectal surgery that means it is not possible for you to have treatment via your rectum
Are allergic to latex
Are not able to have an MRI scan for example, because you have metal in your body such as some types of surgical clips, plates or a pacemaker
Have deposits of calcium in the prostate gland (this will show up when you have an ultrasound)
Have a narrowing of your urinary passage (a stricture) or a tube in place to keep it open (a catheter)

Trial design

This is a pilot study. It will recruit about 56 men who are suitable for HIFU treatment.

Doctors use the results of an MRI scan or detailed biopsies called ‘prostate mapping biopsies’ to find the largest area of cancer in the prostate gland. They then treat this area with HIFU beams. The rest of the prostate gland is not treated.

You go into hospital on the day of treatment and have an enema to make sure your bowel is empty.

Most men will have a general anaesthetic when they have HIFU treatment. When you are asleep, the doctors will put the HIFU probe into your back passage (rectum). Using the MRI scan and biopsy results to see where your cancer is, they will treat the largest area of cancer.

HIFU can cause your prostate gland to swell, making it difficult to pass urine. So the doctors will put a tube into your bladder (a catheter) to help you pass urine. You will have the catheter in place for about 1 to 2 weeks.

The trials team will ask you to complete some questionnaires during the trial. These will ask about how you are, about any side effects you have had and how the treatment has affected you. They are called quality of life studies.

Hospital visits

You will see the doctor and have some tests before you can take part in this trial. You will have

Blood tests including a PSA test
Physical examination including a digital rectal examination (DRE)
An ultrasound via your rectum (trans rectal ultrasound scan, or TRUS)
MRI scan
Prostate biopsy, taken through the skin behind your testicles (perineum) using a transperineal ultrasound scan – you will usually have a general anaesthetic for this

You will be in hospital for a day when you have the biopsy taken through the perineum. The biopsy will take about 30 to 45 minutes.

The HIFU treatment will take about 1 ½ to 2 hours. You should be able to go home later the same day, as long as there is someone at home.

About 1 to 2 weeks after your treatment you go back to hospital to have your catheter removed. Once you have successfully passed urine without the catheter, you will be able to go home.

You have another MRI scan within 30 days of finishing treatment. The trials team will try to organise this on the same day as the catheter is removed. You see the doctors at 6 weeks, 3 months, 6 months, 9 months and 1 year. You will have a physical examination and blood tests at each visit.

About 6 months after treatment you have tests to see how well the HIFU has worked. You have an MRI scan and a trans rectal ultrasound scan (under local anaesthetic) to take more biopsies.

Side effects

HIFU is a new treatment for prostate cancer and trials so far have shown that there are not many side effects.

After treatment, most men will have difficulty passing urine or need to pass urine more frequently or urgently. But these are temporary side effects and happen in the 3 months after treatment.

There are other side effects of HIFU for prostate cancer but they only affect a minority of men treated. Side effects can include

Narrowing of the tube through which urine flows out of the body
Problems getting an erection
Urinary tract infection
Leaking of urine

After HIFU, most men will not produce semen during ejaculation. This is called dry ejaculation.

These are side effects of treating the whole prostate gland with HIFU.
The research team hope that side effects will be less common when they treat only one area of the prostate. But it is too early to say for sure.