A trial looking at high intensity focused ultrasound (HIFU) treatment for prostate cancer that has come back after radiotherapy

Who can enter

You can enter this trial if

• You have prostate cancer that has started to grow again following radiotherapy (you will have a biopsy to confirm this)
• The cancer is contained within your prostate gland (stage T1 or T2 prostate cancer)
• You have a Gleason score of 7 or less
• You had a PSA level of 30 or less before your radiotherapy, and your PSA level is now 15 or less

You cannot enter this trial if

• Your cancer has spread outside your prostate gland or to another part of your body
• You have taken hormone therapy in the last12 months
• Your back passage is inflamed (proctitis)
• You are not able to have treatment via your rectum (for example, you have narrowing of the anus)
• The wall of your rectum is less than 7mm thick (you will have a trans rectal ultrasound scan to assess this)
• You have a large collection of calcium in your prostate (prostatic calcification)
• You have inflammatory bowel disease
• You have a urine infection or inflammation of your prostate (prostatitis)
• You have an abnormal opening (fistula) connecting your bladder and rectum
• You have fluid in your prostate (a seroma), a prostate abscess or narrowing of your urethra
• You have had an implant put into your prostate (for example a stent or a catheter)

Trial design

This trial will recruit about 50 men with prostate cancer. Everyone taking part will have HIFU treatment.

Because the prostate is inside the body, you have HIFU to the prostate via an ultrasound probe in your back passage (rectum). This is called a trans rectal probe. From that position, the ultrasound beams can be directed onto the prostate more accurately.

You will go into hospital either on the day that you have the treatment, or the evening before. Two hours before the treatment you will have an enema to make sure your bowel is empty.

Before you have HIFU you will either have a spinal anaesthetic (epidural) and a sedative, or a general anaesthetic.

You may have either a trans urethral resection of the prostate (TURP) or a trans urethral incision of the prostate (TUIP). This is done to take away any cancer that is pressing on your urethra. The doctor will tell you more about which procedure you will have.

You will have the HIFU treatment straight afterwards. The doctors will insert the HIFU probe into your back passage (rectum). They will treat small areas of prostate tissue, until they have treated the whole prostate gland.

Because the treatment can cause the prostate to swell, the doctors will put a tube into your bladder (a catheter) during your treatment to help you pass urine. You will have the catheter in place for about 5 days.

You will fill in a questionnaire before you start the treatment, and then at 1 month, 3 months, 6 months, and then every 6 months after that. The questionnaire will ask you how you are feeling and what side effects you are having. It is called a quality of life questionnaire.

Hospital visits

You will see the doctors and have some tests before you can take part in the trial. The tests include

• Blood tests (including a PSA test)
• Bone scan
• An ultrasound via your rectum (trans rectal ultrasound scan or TRUS)
• A prostate biopsy, taken via your back passage using a trans rectal ultrasound scanner (TRUS)
• Tests to measure your flow of urine and bladder volume

The doctors will also ask you some questions about your sex life (for example, they will ask you if you have any problems with getting an erection).

You will come into hospital either the night before, or the morning of the HIFU treatment. The whole procedure will take about 3 to 4 hours. You should be able to go home the same day.

About 5 days after the treatment you will have your catheter removed, either at the hospital, or by a community nurse at home.

You will see the doctors at 1 month, 3 months, 6 months, and then every 6 months after that as part of your routine follow up.

You will have a physical examination, blood tests and urine tests at each visit. The researchers will also ask you some questions about your sex life.

About 6 months after the treatment the doctors will take biopsies of your prostate, to see how well the treatment has worked.

Side effects

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

The most common side effects of HIFU for prostate cancer are

• Difficulty passing urine
• Problems getting an erection (impotence)

A less common side effect is leaking urine (urinary incontinence).