A study of radiofrequency ablation to treat cancer in the prostate gland (Pro-RAFT)

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:

Other

This study is looking at treating prostate cancer with radiofrequency ablation (RFA) using a new device called Encage. Radiofrequency is a type of electrical energy. Ablation means destroying completely. The electrical energy heats up the tumour and kills the cancer cells. You have RFA through a probe that goes through your skin into the cancer.

If prostate cancer has not spread outside the prostate gland it is called localised prostate cancer. In this situation, there are different treatments that men can have, such as surgery or radiotherapy. But treatment to the whole prostate gland often causes side effects such as problems getting an erection, urinary problems, diarrhoea and pain or bleeding from the back passage.

More about this trial

For some men, radiotherapy or surgery to remove the prostate gland is not a suitable treatment, or they don’t want to have the side effects that these treatments can cause. For these men, monitoring the cancer until it starts to grow may be an option. This is called active surveillance.

Another option is to treat only the area of the prostate that contains cancer. This is called focal therapy. Radiofrequency ablation is a type of focal therapy.

Doctors will use an MRI scan to see what areas of cancer they think are likely to grow and cause problems. They describe these areas of cancer as being clinically significant. In this study, doctors will only treat clinically significant areas of cancer. But they will watch the untreated areas carefully to check they are not getting worse.

The aims of this study are to

See how well radiofrequency ablation treatment using Encage works for men with localised prostate cancer
Learn more about the side effects of radiofrequency ablation using Encage

Who can enter

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

Have been diagnosed with localised prostate cancer
Have areas of cancer in your prostate gland that could grow and cause problems (clinically significant areas of cancer)
Have had blood tests in the last 3 months that showed your PSA level was 15ng/ml or less
Are aged 40 years or older
Have enough English language to be able to understand the written and spoken information given to you about the study

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

Have prostate cancer that has spread outside of your prostate gland
Have prostate cancer that cannot be seen using an MRI scan
Have had radiotherapy to the area between the hip bones (your pelvis)
Have had any hormone therapy for prostate cancer in the last 12 months
Are not able to have an ultrasound scan via your back passage (a transrectal ultrasound) such as if you have had surgery to your back passage (rectum)
Are allergic to latex
Have already had treatment with radiofrequency ablation or high intensity focused ultrasound (HIFU)
Have had treatment with cryosurgery or microwave therapy
Have had an operation called a transurethral resection of the prostate (TURP) in the last 6 months
Can’t have major surgery, for example because you cannot have a general anaesthetic
Can’t have an MRI scan of your pelvis maybe due to having a metal implant or a permanent cardiac pacemaker
Have metal implants or hollow tubes (stents) in the tube that carries urine from your bladder to the outside (urethra)
Have poor kidney function (your doctor can advise you about this)

Trial design

Doctors need 20 men to take part in this study. Everybody taking part will have radiofrequency ablation using a device called Encage.

On the morning of the radiofrequency ablation treatment, you may have an enema Open a glossary item to clear your back passage. Or you may have a suppository the night before to do this.

You have the treatment while you are asleep under general anaesthetic Open a glossary item . Before the treatment starts, a tube called a catheter is put into your bladder to drain your urine. This may pass though the tube which carries urine from your bladder to the outside of your body. This is called a urinary catheter. Or it may be put into your bladder through your skin. This is called a suprapubic catheter.

When you have the radiofrequency ablation treatment, the trial doctor puts a probe into your back passage. They then put needles through the skin in front of your back passage into your prostate gland. They deliver an electrical current to destroy the cancer cells.

Most men will be able to go home 4 to 5 hours later, but it is possible that you may need to stay in hospital overnight.

The catheter stays in when you go home. The study team will teach you how to look after it. They will also give you painkillers and antibiotics to take at home for a week.

The study team will ask you to complete some questionnaires before you have treatment, 6 weeks after you have treatment, and then every 3 months for up to a year. The questionnaires include questions about any problems you have with getting erections, or bladder problems and about how the treatment affects your day to day living. They are called quality of life questionnaires.

They will also ask you to complete a diary where you need to make a note of any visits you have to do with your health that are not part of this study.

Hospital visits

You will have had both an MRI scan and prostate biopsy before you see the study doctors. When you see the study team you will also have some blood tests done to check your PSA level and your general health.

You usually have radiofrequency ablation treatment as an outpatient. Occasionally men may need to stay in hospital overnight.

After treatment you will go back to the hospital 3 to 10 days later. At this visit the catheter will be removed and you will have an MRI scan.

6 weeks and 3 months after treatment you will have some blood tests and speak with the study team. The doctor will ask how you are and check your latest blood test results.

6 months after treatment you will have some more blood tests and an MRI scan. You will also have a prostate biopsy. This is all to make sure there is no cancer left in your prostate gland that the doctors think could grow and cause problems. You should not need to stay overnight in hospital at this visit.

After you have had these tests, the study team will be in touch to discuss the results. If the results show you have cancer in the prostate gland the study team may either offer to re-treat you with radiofrequency ablation or suggest another type of treatment.

9 months after treatment you will have some blood tests and speak with the study team. The doctor will ask how you are and check your latest blood test results.

Your final study visit will be 12 months after treatment. You will need to have an MRI scan and blood tests. The doctor will ask how you are and check your latest scan and blood test results. They will also discuss any future follow up with you.

Instead of visiting the hospital for some of these appointments you may be able to have a telephone catch up and have any blood tests done locally. Talk to the doctor about which will be best.

Side effects

As radiofrequency ablation using the Encage device is a new treatment for prostate cancer there may be some side effects we don’t know about yet. The following are what the study team know from previous studies using Encage and other similar treatments

Urinary tract infection
Narrowing of the tube that carries urine from your bladder to outside your body (the urethra)
Not being able to pass urine (urine retention)
Uncontrolled leaking of urine (urinary incontinence)
An abnormal opening between the bladder and back passage (recto-urethral fistula)
No semen being produced if you have an orgasm (Dry ejaculation)
Reduction in the amount and quality of semen you produce
Reduced fertility (ability to father a child)
Inability to get an erection
Infection of the tubes surrounding your testicles (epididymitis)

The study team believe that radiofrequency ablation should not have many side effects but one of the aims of the study is to look into this and they will be monitoring you carefully. You will have a telephone number to call if you are concerned about anything.