"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”
A trial of MR guided focused ultrasound to treat men with early stage prostate cancer
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
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
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)
Gleason scoreis 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
epiduralor general anaesthetic(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
inflammationof the prostate (prostatitis) caused by a bacteriaor 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 (
- 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) 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 mediumthat is used in the MRI scan
- Weigh more than 113kg (17½ stone)
- May want to have children in the future
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 either a
After the anaesthetic has taken affect and before treatment you have a urinary
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.
You see the doctor to have some tests before taking part in this trial. These tests include
- A physical examination
- Blood tests
- Rectal examination (Digital rectal examination – DRE)
- Needle biopsy (if not done in the past year)
- CT scan
- MRI scan
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.
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.
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.
Professor W Gedroyc