A trial of MR guided focused ultrasound to treat men with early stage prostate cancer

Cancer type:

Prostate cancer




Phase 2

This trial is looking at magnetic resonance (MR) guided focused ultrasound to treat men with early stage prostate cancer. This trial is for men with prostate cancer that is completely contained in the prostate gland.

More about this trial

Doctors can treat prostate cancer by removing it with surgery. As with all treatments, this has side effects that can affect your quality of life Open a glossary item.

MR guided focused ultrasound uses high power ultrasound waves to heat up the cancer and destroy it. To have the treatment, a doctor inserts a probe into your back passage (rectum) next to your prostate gland. They look at images from an MRI scan Open a glossary item to direct the ultrasound waves through the probe to the area of cancer. A trained member of the research team carefully controls the ultrasound waves so that only the area of cancer is treated.

The researchers think that MR guided focused ultrasound may work as well as surgery to treat prostate cancer and have fewer side effects.

The aims of this trial are to find out

  • How well MR guided focused ultrasound works for early prostate cancer
  • How safe it is
  • How it affects quality of life

Who can enter

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

  • You have prostate cancer that is contained within the prostate gland (localised prostate cancer)
  • You have cancer in just one area of your prostate and if it can be seen on a scan is only in one half of the lobes of the prostate gland (stage T1 or T2a)
  • Your PSA blood test result is 20ng/ml or less (your doctor can confirm this)
  • Your Gleason score Open a glossary item is 7 (your doctor can confirm this)
  • Your prostate gland is 60cm or less in volume (your doctor can confirm this)
  • You are able to have an epidural Open a glossary item or general anaesthetic Open a glossary item (a doctor who specialises in giving anaesthetics (an anaesthetist) will assess you for this)
  • Your other blood test results are satisfactory
  • You are at least 50 years old

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

  • Have cancer that is very close to the prostate gland capsule (your doctor can confirm this)
  • Have cancer that is very close to the muscles that control the flow of urine from the bladder (your doctor can tell you this)
  • Have had hormone therapy for your prostate cancer in the last 6 months
  • Have had any other treatment for your prostate cancer
  • Have inflammation Open a glossary item of the prostate (prostatitis) caused by a bacteria Open a glossary item or ongoing pain in the area between your hips (pelvis)
  • Have an infection in your bladder or the tubes that carry urine out of your body (UTI Open a glossary item)
  • Have problems with urine leaking and this interferes with your daily living (your doctor will ask you to fill in a questionnaire to assess this)
  • Have an area of calcium (calcification Open a glossary item) in your prostate gland that could interfere with the ultrasound waves (your doctor can confirm this)
  • Have a blockage in the tube that carries urine out of your body (urethra)
  • Have a problem with your back passage (rectum) that could affect how the treatment is given, such as irritable bowel disease or haemorrhoids (the trial team can advise you about this)
  • Have certain heart problems (the trial team can advise you about this)
  • Have had another cancer in the last 5 years apart from non melanoma skin cancer
  • Have taken part in another clinical trial in the last month
  • Are not able to have an MRI scan (for example if you have a pacemaker, metal clips, any other metal in your body, or aren’t able to be in a small space for a period of time)
  • Are sensitive to a substance called contrast medium Open a glossary item that is used in the MRI scan
  • Weigh more than 113kg (17½ stone)
  • May want to have children in the future

Trial design

This is an international phase 2 trial. The trial team need 30 men to join in the UK and 80 men in total worldwide.  

You have treatment at St Mary’s Hospital, London.

You have a special diet called a low residue diet for 2 days before your treatment. You cannot eat or drink anything for 12 hours before the treatment.

You have laxatives Open a glossary item to help clear your bowels the evening before and the morning of your treatment. You have an enema Open a glossary item 2 hours before treatment to make sure your back passage is clear.

You have either a general anaesthetic Open a glossary item that will put you to sleep or an epidural Open a glossary item so that you can’t feel the lower half of your body without putting you to sleep.

After the anaesthetic has taken affect and before treatment you have a urinary catheter Open a glossary item put in to drain away your urine. This is taken out after treatment is finished.

When you have the treatment, an ultrasound probe is inserted into your back passage (rectum). Then using the MRI images the researchers will direct high power focused ultrasound waves to the area of cancer.

The trial team will ask you to fill out a questionnaire before you start treatment a week after treatment then at 3 months, 5 months, 9 months, 1 year, 18 months and 2 years after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see the doctor to have some tests before taking part in this trial. These tests include

You go into hospital the day before treatment and stay for another 2 to 3 days after treatment.

After treatment you see the doctor at

  • 1 week
  • 1 month
  • 5  months
  • 9 months
  • 1 year
  • 18 months
  • 2 years

You have a PSA blood test each time. You have a rectal examination at 1 year and 2 years. You have a needle biopsy and MRI scan at 5 months and 2 years.

Side effects

The probe is inserted into your back passage and this may cause some damage to your anus or the wall of the back passage. Having a general anaesthetic or epidural reduces the possibility of damage.   

After the ultrasound treatment you may have a mild fever for a day. There may be some pain where you were treated for which you can take simple pain killing drugs.



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 W Gedroyc

Supported by


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Last review date

CRUK internal database number:


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

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

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