A trial looking at high intensity focused ultrasound or surgery to treat prostate cancer contained in one part of the prostate gland (PART)

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:

Pilot

This trial is comparing high intensity focused ultrasound (HIFU) with surgery to treat men with prostate cancer. It is recruiting men who have a medium risk of their cancer coming back and only have cancer in one area of their prostate gland.

More about this trial

If you have prostate cancer that is contained within the prostate gland, your doctor may suggest they monitor you (active surveillance) or offer you a choice of treatments. These standard treatments include an operation to remove the prostate (radical prostatectomy) or radiotherapy to the prostate gland. But these treatments have side effects, including urinary problems (such as leaking urine) and difficulty getting an erection.

Doctors think that only treating the areas of cancer in the prostate may be just as good as standard treatments and may cause fewer side effects. Only targeting certain areas of the prostate is called focal therapy or ablation. High intensity focused ultrasound (HIFU) is a type of ablation that uses sound waves. Doctors direct the sound waves at the tissues containing cancer, causing the tissues to heat up and die.

This trial has 2 parts. The first part is the feasibility study. The researchers hope to find out if it is possible to carry out the same research in a larger number of men. For example, they want to know whether men will be willing to join the trial.

If the first part is successful, the researchers will then start the second part. The aims of the trial are to

  • Find out whether focal therapy or surgery is a better treatment for men whose prostate cancer is in one part of their prostate
  • Learn more about the side effects of each treatment

Who can enter

You may be able to join this trial if you have prostate cancer that is contained within one area of your prostate gland and your doctor thinks it is unlikely to grow or spread for a few years (medium or intermediate risk localised prostate cancer). All of the following must also apply. You

  • Have had samples (biopsies Open a glossary item) taken from your prostate gland that show that you only have significant cancer on 1 side of the prostate
  • Have a Gleason score of at least 6 and a PSA blood test result of no more than 20 (your doctor can advise you about both of these)

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

  • Are not fit or well enough to have surgery
  • Have significant cancer in both sides of your prostate gland
  • Have prostate cancer that is considered to be low risk or high risk  (rather than medium risk)
  • Have already had treatment for prostate cancer
  • Have been diagnosed with another type of primary cancer Open a glossary item
  • Are not able to have an ultrasound probe into your back passage to scan your prostate (transrectal ultrasound) for any reason
  • Are allergic to latex

Trial design

The researchers need 100 men to join the first part of the trial which is a feasibility study. The aim of the feasibility study is to find out if it is possible to carry out the same research in a larger number of men.

If the first part is successful, the second part will recruit between 600 and 800 men.

Both parts 1 and 2 are randomised. Men are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Men in one group have an operation to remove their prostate gland (prostatectomy). Men in the other group have focal therapy using high intensity focused ultrasound (HIFU) to treat the areas of cancer in the prostate.

If you have a prostatectomy, you may have robotic assisted keyhole surgery. If you have this type of keyhole surgery, the surgeon cuts 6 small holes into the skin of your abdomen and uses these holes to insert their instruments and carry out the operation. You have a general anaesthetic Open a glossary item so you are asleep throughout your operation.

Sometimes it is not possible to do this operation with keyhole surgery. So the surgeon may need to remove the prostate gland by making a larger cut at the bottom of your abdomen. This is called an open prostatectomy.

During the operation the surgeon will join the waterpipe (urethra) to the bladder with some internal stitches. This join needs to heal, so the surgeon will put a catheter through the tube which carries urine from your bladder to the outside of your body. This called a urethral catheter. It drains your urine into a bag which can be emptied and stays in place for 1 to 2 weeks while the join heals.

If you have HIFU, you have a general anaesthetic so you are asleep throughout the treatment. You have an ultrasound device put into your back passage rectum Open a glossary item, similar to when you had a transrectal ultrasound and biopsies. Your treatment takes about 1 to 2 hours.

HIFU can make your prostate gland swell, so your surgeon will put a catheter into your bladder through the waterpipe. It drains your urine into a bag and stays in place for about 1 week.

The trial team will ask you to fill out a questionnaire before you start treatment, 6 weeks after treatment and then on 7 different occasions over the next 3 years. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You will see the doctors and have some tests to find out if you are able to take part in this trial. The tests include

If you have robotic assisted keyhole surgery you may stay in hospital for 1 or 2 nights. If you have an open prostatectomy you stay in hospital for about 4 to 7 days.

If you have high intensity focused ultrasound (HIFU) you may have it as a day patient, or you may stay in hospital for 1 night following treatment.

You go back to hospital to have your catheter removed 1-2 weeks after the procedure.

Men in both groups go back to see their doctor 6 weeks after treatment. You have further appointments every 3 months for the first year, then about every 6 months for 3 years. At each appointment, your doctor will check how you are and ask about any side effects you have. You also have a PSA blood test as this will be an important test to check that the treatment has worked.

If you have HIFU, you have an MRI scan and prostate biopsies 1 year after treatment, then 2 years later. If you have had your prostate gland removed you don't need an MRI scan or biopsy.

Side effects

Possible complications of having surgery to remove the prostate gland (prostatectomy) include the risk of infection and bleeding. Long term side effects include

We have more information about having a prostatectomy.

Complications of having high intensity focused ultrasound include the risk of infection. Doctors don’t yet have any information about the long term side effects of this treatment. HIFU may cause erection problems and leakage of urine. But the trial team think that men having HIFU may have fewer side effects than men having a prostatectomy.

We have more information about high intensity focused ultrasound.

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 Freddie Hamdy

Supported by

NIHR Health Technology Assessment (HTA) programme
University of Oxford

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12704

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

A picture of Keith

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

Last reviewed:

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