Focal Therapy

Focal therapies only target areas of your prostate that contain the most significant cancer. 

What is focal therapy?

  • Focal therapies only target areas of your prostate that contain the most significant cancer. Doing this:
    • Avoids damage to the surrounding tissues 
    • Reduces side effects. 

These differ from whole gland therapies that involve treating the whole prostate gland for example, prostatectomy or radiotherapy.

 

  • There are different types of focal therapy: 
    • High intensity focused ultrasound (HIFU)
    • Cryotherapy (sometimes called cryoablation or cryosurgery)
    • Irreversible electroporation (IRE and sometimes called Nanoknife).
Image
Treatment focused on one area of cancer on the prostate
Special information about focal therapy

Are focal therapies available in the NHS?

Focal therapies are available in the UK:

  • Focal HIFU, Cryotherapy and Irreversible electroporation are available from the NHS in England in a few centres under ‘special arrangements’. Although these centres are mostly in London or the South of England, numbers are increasing across the country.
  • As part of a clinical trial. Note If you agree to take part in a trial, there is no guarantee that you will get the treatment you want.
  • They may also be available privately. 

 

What are 'special arrangements'?

Special arrangements are put in place by the National Institute for Health and Care Excellence (NICE) if there is a lack of long-term data on the effectiveness of a treatment. Before deciding on focal therapy, your healthcare team need to talk to you about:

  • What is currently known about focal therapies – the pros and cons
  • The uncertainty that surrounds focal therapies

 

What does the National Institute for Health and Care Excellence do?

NICE provides guidance on:

  • How different conditions should be treated
  • What treatments should be made available.
  • Learn more about NICE and what they do by visiting their website.

    People sitting around a big round table making decisions

Informed consent

Informed consent is even more important for treatments under a special arrangement. 

Informed consent means that you must be given all the information about:

  • What the treatment involves, including the benefits and risks
  • Whether there are reasonable, alternative management options. This could include talking about your suitability for active surveillance. Visit our active surveillance page (page opens in a new tab) for more information.  

 

Man talking to his doctor

 

Healthcare professionals who use focal therapies must collect information about:

  • What they did 
  • How well the treatment worked (statistics). 

This information may be:

  • Published in journals
  • Presented at conferences and 
  • Shared with NICE. 

They do not share information about individual patients. 

Focal HIFU: 

Evidence suggests that this procedure is safe enough, but there is not enough evidence about how well it works. So, it can only be done with special arrangements. This means you will have regular appointments afterwards to check how well it is working or if it has caused problems’. NICE 5th April 2023. 

For more information you can visit the NICE website (this link will open in a new external tab). 

Cryotherapy: 

The statement from NICE on cryotherapy is similar to that for HIFU. For more information, you can read the NICE statement on cryotherapy (this link will open in a new external tab). 

Irreversible electroporation:

'There is not enough evidence about how well this procedure works in the long term. So, it can only be done with special arrangements. This means you will have regular appointments afterwards to check how well it is working or if it has caused problems..' NICE July, 2023. 

For more information, visit the NICE website (this link will open in a new external tab).

  • Focal treatments have less side-effects than whole gland therapies.
  • However, we do not yet know whether focal therapies are as effective a cure as whole gland therapies over a long period of time (10-15 years). 
  • This is because there is less data available. This is especially so for cancers of grade group 3 or above. Visit our grading and staging page (this link will open in a new tab) for more information on how prostate cancer is graded.
  • Some smaller cancers will not need active treatment. Other larger cancers will need whole gland treatment. 
  • However, there are some small grade 2 and 3 cancers that are at risk of growing. 
  • Studies show these cancers can be effectively treated by focal therapy. However, there are a lack of randomised control trials comparing focal to whole gland treatments. 

     

What are randomised control trials?

Randomised trials compare two or more different groups of patients. There is usually: 

  • A control group that gets the standard treatment or placebo 
  • A treatment group that gets the new treatment. 

Randomisation is when people are put into either one of these groups by chance. A bit like flipping a coin. A computer decides which group you are in.

Randomisation is the best way of making sure that the results of trials are free from bias. 

Visit our clinical trials page (this link will open in a new tab) for more information on how clinical trials work.

 

Important things to know

Who can have focal therapy?

You may be able to have focal therapy if:

Your prostate cancer is contained within your prostate (localised prostate cancer) and your:

  • PSA is less than 20 and
  • Gleason grade is 7 (4+3) on your biopsy, affecting just one side of the prostate and the tumour can be seen on an MRI in the same area.
  • Gleason grade is 6 (3+3), but your tumour size is bigger than 6mm and your MRI score is 3, 4 or 5. This type of tumour could also undergo monitoring instead using active surveillance (this link will take you to a new tab). You will need to discuss this with your doctor. 
  • Sometimes a small amount of low-grade cancer, Gleason 6 (3+3), less than 6mm can be left untreated in other parts of the prostate. These areas are then monitored with active surveillance.

 

What are the possible benefits of focal therapies?

  • You are likely to have fewer side effects than you would have with other treatments like radiotherapy and surgery.
  • If your cancer comes back and is contained inside your prostate, you can still be offered other treatments. This may include radical prostatectomy, radical radiotherapy, or even focal therapy again. These will aim to cure your cancer. You may hear them called salvage treatments.
Survival up to 10 years after focal therapy

Please note: Data relates to cryotherapy and HIFU only.

What are the possible disadvantages of focal therapies?

  • There is still a risk of side-effects as no treatment is side-effect free.
  • There is more chance of your cancer coming back than with treatments like radiotherapy and surgery.
  • You may need more surveillance after treatment in case your cancer comes back. You can have regular tests that will help to pick up any changes quickly. 
  • It is not yet clear which patients will benefit from focal therapies. Research is ongoing. The National Institute for Health and Care Excellence (NICE) will update their statements when more information is known.
  • You may have to travel a distance to get focal therapy. 
Image
bob
“I was told that men, in time, can recover from Erectile Dysfunction. I am now a year and a half on from the therapy and I’m pleased to say that it is getting better with every week.”
Bob
Frequently asked questions (FAQs) about focal therapies

Your doctor will look at the results of your:

  • MRI
  • Biopsy

They will then talk to you about all the treatments that are suitable for you. This will include the possible benefits as well as the risks and side effects.  Your doctor and specialist nurse can support you to make a decision that is right for you and your lifestyle.

 

Black man with doctor discussing scan results

HIFU uses high intensity ultrasound waves to kill prostate cancer cells. This is done by heating the cancer cells to a high temperature. You will need a general anaesthetic.

 

Image showing the HIFU procedure

 

What happens during HIFU?

  • Your doctor will pass a thin tube called a catheter into your bladder. This will drain your pee into a bag.
  • The HIFU probe is put inside your back passage (rectum).
  • The probe lets your doctor see a picture of your prostate. It also puts out ultrasound waves. These pass through your rectum to your prostate.
  • Your doctor can move the HIFU probe into different positions. This allows them to treat the prostate cancer cells. 
  • It is better at treating tumours in the peripheral part of the prostate. This is the largest part of the prostate. It is at the back of the prostate near the wall of your back passage (rectum). 
  • HIFU may struggle to treat the anterior area of the prostate. This can be found in front of your urethra. The urethra is the tube that takes your pee from your bladder to the outside.

The whole procedure can take between 1 and 3 hours. This will depend on the size of the area that needs treatment. 

Cryotherapy kills cancer cells by freezing them. It is done under a general anaesthetic. 

 

Image showing the cryotherapy procedure

 

What happens during cryotherapy?

Your doctor will:

  • Pass an ultrasound probe into your back passage (rectum). This helps them to see your prostate. 
  • Put warm water put into your bladder through a thin tube called a catheter. This protects:
    • Your bladder
    • The tube that carries pee from your bladder to the outside (urethra).
    • The sphincter muscle that stops urine leak.
  • Pass 5-8 thin needles through the area between your rectum and scrotum (perineum) into your prostate. 
  • Pass a special gas called argon through the needles. This freezes and kills the cancer cells. 

Irreversible electroporation uses electrical pulses to destroy cancer cells. It is done under a general anaesthetic. 

 

What happens during irreversible electroporation?

Your doctor will pass:

  • An ultrasound probe into your back passage (rectum). This helps them to see your prostate. 
  • A thin tube called a catheter into your bladder. This will drain your pee into a bag.
  • 3-6 thin needles through the area between your rectum and scrotum (perineum) into your prostate. 
  • Short electrical pulses through the needles.

The needles will be taken out at the end of the treatment.

  • You may be asked to come along to the hospital for a pre-assessment. This will be one-to-two weeks before your treatment. 
  • You will have a general anaesthetic. So, you will be asked to fast for about six hours before you have your treatment. 
  • You will be asked to empty your bowels on the morning of your surgery. So, you may need to use a small enema. An enema puts a small amount of fluid into your rectum. This helps to clear out your bowel. You can do this yourself. 
3 small microenemas in the palms of teh hands
Microenemas

What happens on the day of my treatment?

Your surgeon will visit you to:

  • Explain what they are going to do
  • Give you the chance to ask questions
  • Ask you to sign a consent form. This is a written record that says you have agreed to the operation and the anaesthetic. Always make sure you understand what is going to happen before you sign the form. Ask your doctor about any worries you may have.

 

Your anaesthetist who will ask you questions about:

  • Your health
  • Allergies
  • Pain control after the operation.   

 

You may be asked to wear a pair of compression stockings.  These are sometimes called TED stockings. You may also have a heparin injection. This helps to thin your blood. Both help to stop blood clots (deep vein thromboses) forming in your lower legs. 

 

Compression stockings
  • You will be encouraged to get up and about as soon as possible. This helps to stop blood clots.  
  • You will have a tube to drain pee from your bladder into a bag. This is called a urinary catheter. A nurse will show you how to care for the 

    Diagram showing urinary catheter in bladder

    catheter.

  • The catheter is removed at clinic, 3-10 days after the treatment. 
  • You will be given a course of antibiotics to take for up to a week. These lower the risk of getting an infection in your pee. 
  • You should be able to go home the same day. You are not allowed to drive for at least 24 hours after a general anaesthetic. So, you will need someone to pick you up from the hospital. 
  • You may feel a bit tired for a few days after the treatment. 

You may have some pain in your penis and back passage. Your healthcare team will talk to you about painkillers. 

  • Yes. You will need to take some time off work to recover. 
  • How long you need to take off will depend on the type of work that you do. 
  • Your doctor will advise you when it is safe to get back to work. 

It is the responsibility of the doctor who treated you to arrange a suitable follow-up plan. This may include regular PSA tests, MRI scans and prostate biopsies. Ask your doctor about what tests you will need after your treatment.

Blood in test bottle labled PSA test

After your treatment, you will have your PSA levels checked:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

If your cancer comes back, your doctor will talk to you about other treatments. The treatment you can have may depend on:

  • The grade and stage of the cancer. 
  • The treatments you have already had.

     

Possible treatments may include: 

  • Focal therapies may affect the amount and quality of your sperm. It may mean that you will have problems getting someone pregnant. 
  • If you think you may want children, please talk to your doctor before starting treatment. 
  • You may be able to have some of your sperm saved and frozen. This is called sperm banking. You can learn more about sperm banking on the Human Fertilisation and Embryology Authority website (this link will open in a new external tab). Cancer Research UK also have information about sperm collection and storage (this link will open in a new external tab).
Sperm banking illustration
  • You may still be able to get someone pregnant. 
  • There is a chance that focal therapies may affect your sperm. This may theoretically harm babies who are conceived during your treatment. 
  • You should use contraception during treatment. You can talk to your healthcare team for advice about safe sex during and after focal therapy. 

About this information

  • This information was published in June 2023. We will revise it in June 2024.
  • References and bibliography available on request.
  • If you want to reproduce this content, please see our Reproducing Our Content page (this link will open in a new tab).

What is risk?

  • Risk is the chance something bad could happen when we do something. Even simple things such as walking down the stairs can have risks. But we take risks because we think it will be worth it. We need to think about both the benefits and risks of what might happen when we do something.
  • You should always ask your healthcare team about both the benefits and risks of any treatment.
  • Remember if they tell you about a risk, it doesn‘t mean it will happen to you. They may say one man in 10 who has this treatment will have a side effect. But they can‘t tell you if you will be the ‘one’ man who gets this side effect.
Image
 showing a see saw with risk on one side and benefits on the other
What are the risks of focal therapies?

Peeing

1. Leaking pee (needing to use a pad some or all of the time) 

 

After 12 months

Between 1 in 100 and 2 in 100 people leaked pee.  

Leaking tap

 

 

 

 

 

 

 

2. Problems peeing (needing to pee at night, needing to pee a lot and needing to pee in a hurry). 

 

The first 6 weeks after focal therapy

All men experience problems peeing due to the prostate healing.peeing into a toilet

 

After 12 months

5 in 100 people had problems peeing. 

 

 

 

 

 

Bowel problems 

Pooing more often, needing to poo quickly, passing mucous or blood in poo).

 

After 12 months

Less than 1 in 100 people had problems with their bowels. 

Person sitting on toilet

 

 

 

 

 

 

Please note: All data relates to cryotherapy and HIFU only.

1. Problems getting or keeping an erection (erectile dysfunction)

 

In the first 2-3 months

Most men will have problems getting or keeping an erection months and will need to use medication to help.Erectile dysfunction

 

After 12 months

Between 5 in 100 and 20 in 100 people had problems getting or keeping an erection.

 

 

 

2. Dry orgasms

 

Dry orgasm

 

After 12 months

50 in 100 people had dry orgasms.

 

 

 

 

Please note: All data relates to cryotherapy and HIFU only.

Over a 5-10 year follow-up:

  • Between 20 and 30 in every 100 men need to have further focal therapy.
  • Between 5 to 10 in every 100 men need to have surgery or radiotherapy.

Please note: All data relates to cryotherapy and HIFU only.

  • All of the data shown relates to cryotherapy and HIFU only. 
  • Focal Therapy data is based on UK HEAT and UK ICE registries.
  • These registries are for data collection of focal therapy outcomes.
  • The HEAT registry of HIFU cases has been collecting data on all cases and outcomes in the UK since 2004. 
  • The ICE registry for cryotherapy has been collecting outcomes on cases treated over the last 10 years throughout the UK.
  • The registries are overseen by Focal Therapy UK. 
  • Focal Therapy UK is a user group of focal therapy urologists and urological surgeons committed to high standards of training, conduct and delivery, and reporting of the outcomes of focal therapy in the UK.  
  • More information can be found by visiting their website

What is the impact?

  • We asked real visitors to the infopool to share their experience of this treatment. They told us how this treatment had impacted their everyday lives in a number of different areas.
  • The numbers and images below represent how many people said this treatment had impacted them ‘a lot’ in each of the different areas. As this site is new, this is currently based on a relatively small group of people who have responded about this treatment. Please take this into account when reviewing the information below.
  • For example, imagine it says ‘25 in 100’ underneath ‘physical and social wellbeing’. This means that 25 out of 100 people who shared their experience of this treatment told us it impacted their ‘physical and social wellbeing’ a lot. However, it would also mean that 75 out of 100 people said it had not impacted them a lot.

Physical and social wellbeing

Enjoying activities such as walking or going out to the pub

54 out of 100

Effect on relationships

Ability to make good connections with others

8 out of 100

Sexual activity

Ability to reach sexual arousal, either physically or emotionally

38 out of 100

Sense of self

Knowing who you are and what motivates you

17 out of 100

Wellbeing and quality of life

Feeling good and functioning well in your personal and professional life

29 out of 100

Mental and emotional health

Ability to think clearly, make good decisions, and cope with your emotions

25 out of 100

Fatigue

Feeling of constant physical and/or mental tiredness or weakness

29 out of 100

Ethnicity
Age
Work
Sexual Orientation