A study looking at robotic surgery for prostate cancer that has come back (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 for men who have had treatment that only targeted a certain area of their prostate (focal ablation therapy) and their cancer has come back.

More about this trial

There are a number of treatments that can be used to just treat an area of cancer in the prostate gland. These include internal radiotherapy (bracytherapy), cryotherapy and high intensity focused ultrasound (HIFU). These treatments are relatively new and so doctors are now looking at the best way to treat men if their cancer comes back.

Surgery to remove the prostate after previous treatment is difficult. This is because previous treatment might have caused problems such as:

getting an erection
urinary problems
diarrhoea
pain or bleeding from the back passage

Doing surgery may make these problems worse. But treatments that only target a certain area of the prostate gland usually cause fewer problems. This is because the tissues surrounding the prostate gland are not so affected.

Doctors think that it might be possible to use assisted robotic surgery after focal ablation therapy because the overall side effects should be less.

Assisted robotic prostate surgery is when a surgeon does the surgery but uses a special machine (robot) to help remove the prostate gland. It is a type of keyhole or laparascopic surgery. It is also called da Vinci surgery.

The main aim of this study is to see how successful robotic prostate cancer surgery is for men whose cancer has come back after focal ablation therapy.

The doctors will also test any prostate cancer tissue they remove to see if they can work out why the prostate cancer has come back after treatment.

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

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

You have had a cancer sample (biopsy ) taken in the last 6 months that shows that your prostate cancer has come back or you still have prostate cancer following focal ablation therapy
You have had had focal ablation therapy using either high intensity focused ultrasound (HIFU), cryotherapy, bracytherapy, electroporation or photodynamic therapy
Your PSA is less than 20
You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
You have had an MRI scan that shows that your urinary sphincter (the muscle used to keep urine in your bladder) was not affected by your previous treatment
You are aged 18 or older

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

Have prostate cancer that has spread elsewhere in the body (metastatic prostate cancer)
Have needed to have treatment that affects your whole body (systemic treatment) for any other type of cancer in the last 5 years apart from treatment given after surgery with the aim of curing the cancer, non melanoma skin cancer or superficial transitional cell carcinoma of the bladder
Have scar tissue (adhesions) in your back passage (rectum) caused by your previous treatment
Have a serious illness such as an autoimmune disease that is causing symptoms
Have a condition affecting your liver called cirrhosis
Have any condition that causes problems with blood clotting (coagulopathy)
Are very overweight, this means that you have a BMI greater than 45
Have previously broken your pelvis
Are not able to have a general anaesthetic.

Trial design

Doctors need 24 men to take part in this study.

Everyone taking part has an assisted robotic prostatectomy (removal of the prostate gland). The doctors doing the surgery have been trained to use the special machine (robot) that helps during the operation.

Before your operation you need to complete some questionnaires about whether you have any problems with controlling your bladder or erections as well as some general health questions. These questionnaires are called quality of life studies. You also complete them at your follow up appointments.

Hospital visits

You need to go to hospital before your operation. This is to have a number of tests such as blood tests and a heart trace (ECG Open a glossary item ) to make sure you are fit enough to have surgery.

The surgery takes place at Guys and St Thomas’ Hospital in London or University College London Hospital.

You have the operation under general anaesthetic. It takes between 2 to 4 hours. Straight after surgery you go to intensive care so you can be closely monitored.

You should be able to go home about 2 days after your operation.

You have a tube (catheter) put into your bladder to drain away the urine. This is put in place during the operation and can be removed 2 to 3 weeks later.

Within 8 weeks after your surgery you see the doctors. They will see how you are and talk to you about the cancer they removed. Most men will not need any additional treatment but a few might need radiotherapy. This will be explained during this meeting.

The doctors then see you every 3 months for the 1st year following your surgery.

Side effects

Like all surgery to the prostate gland there is a risk afterwards of

problems with bladder control
difficulty having an erection
injury to your back passage (rectum)

The doctors think these risks are lower with robotic assisted prostatectomy. Part of the reason for the study is to learn more about the side effects of this surgery.