A study looking at two different types of surgery for prostate cancer (ELIPSE)
Cancer type:
Status:
Phase:
This study is comparing 2 different types of routine surgery for prostate cancer that has a high risk of coming back.
More about this trial
High risk localised prostate cancer is cancer that has not spread elsewhere in the body. But it has a high risk of coming back. You might have surgery to remove the prostate to treat this. Sometimes, the surgeon also removes the nearby 
. The aim is to reduce the risk of the cancer coming back.
Doctors don’t know for sure if removing the lymph nodes reduces the chance of the cancer returning or not. There can be complications after removing lymph nodes. These include injury to nerves and blood vessels, fluid collecting at the operation site and blood clots. This might cause pain, infection, swelling of the scrotum or legs, and problems passing urine. Removing lymph nodes might also cause blood clots in the legs, lungs or both. So, surgeons don’t want to remove the lymph nodes if they don’t need to.
In this study, some men have surgery to remove the prostate. And some have surgery to remove the prostate and lymph nodes nearby. Both are routine surgeries in the National Health Service (NHS).
The main aims of the study are to compare the surgeries to find out:
- which surgery works best to stop the cancer coming back
- more about the complications after surgery and how long it takes to recover
- about
quality of life
Please note, you might not benefit directly from taking part in the study. This research could help to find out the best surgery for prostate cancer surgery in future.
Who can enter
The following bullet points are a summary of 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.
Who can take part
You may be able to join this study if all of the following apply. You:
- are suitable to have surgery to remove your prostate
- have prostate cancer that hasn’t spread but has a high risk of growing or spreading. This is high risk localised prostate cancer. It includes one or more of the following:
a Gleason score of 7 or highera prostate specific antigen (PSA) of 20ng/ml or higher- the cancer has broken through the covering of the prostate gland. This is stage T3 cancer.
- are at least 18 years old
Who can’t take part
You cannot join this study if any of these apply. You:
- have had hormone treatment in the 3 months before you join the study
- have already had surgery to remove the prostate,
radiotherapy or focal therapy such as cryotherapy or high intensity focused ultrasound (HIFU)
Trial design
This is a surgical study. The team need 1,080 men from the UK to take part.
It is a randomised study. A computer puts you into a treatment group. Neither you nor your doctor will be able to decide which group you are in.
There are 2 treatment groups. You have 1 of the following:
- surgery to remove the prostate and the
lymph nodes - surgery to remove the prostate without removing the lymph nodes
Your surgical team will arrange a date for your surgery. They will talk to you about the surgery, what it involves and how long you’ll be in hospital for.
The surgeon will record an image of the internal area when you have your operation. This is if you have lymph nodes removed during the surgery. The image is like a photograph showing that you have had your lymph nodes removed. It won’t be possible to identify you from it.
Questionnaires
The study team ask everyone to fill out some questionnaires before surgery.
One questionnaire asks how you’ve been feeling and if you have any side effects. This is called a quality of life study. The other questionnaire asks you to fill in some information about your recent contact with the NHS. For example, how far it is to travel to your GP or hospital.
At 3 months you fill in questionnaires about your:
- quality of life
- recovery from surgery and any complications you may have had
At 1 year, 2 years and 3 years, you fill in some more questionnaires about:
- your quality of life
- your use of healthcare services
- whether your health impacts work or regular daily activities
- further treatment you may have had for prostate cancer
The questionnaire packs take about 15 minutes to complete each time. The team either email or text you a link and you can then complete the questionnaires online. Or they can post paper copies of the questionnaires to you. You complete these at home and return them in the post in the self-addressed stamped envelope provided. You can choose how you would like to get the questionnaires.
Hospital visits
You won’t have any extra hospital visits or tests as a result of taking part in this study. You have routine follow up with your doctor. They can tell you how often you have these appointments.
The study team will see how everyone is getting on at 3 months and then once a year for up to 3 years. They will check your medical notes to see how you are. They collect information about results, other tests you may have and any other treatments you have for prostate cancer.
At 3 years, a member of the study team will call you to ask if you had any extra visits to hospitals, other than the one where you had surgery.
The team may plan longer term follow up. This might involve checking .
Side effects
Your doctor monitors you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
Both types of surgery are already routinely used in the NHS to treat men with prostate cancer. There are some possible risks and benefits of both.
The possible pros and cons of surgery to remove the prostate and not the lymph nodes might include:
- a higher chance of the cancer coming back
- a lower chance of complications such as injury to nerves or blood vessels during the operation
- a lower chance of complications such as fluid collection or clots in legs or lungs that need treatment
- reducing the time your operation takes
The possible pros and cons of surgery to remove the prostate and the lymph nodes might include:
- a lower chance of the cancer coming back
- a higher chance of complications such as injury to nerves or blood vessels during the operation
- a higher chance of complications such as fluid collection or clots in legs or lungs that need treatment
- an increase in the length of time your operation takes meaning a longer
general anaesthetic
Your doctor will talk to you about all the possible side effects of surgery. You will have a chance to ask them any questions you may have.
We have more information about surgery to remove the prostate cancer.
Location
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.
Chief Investigator
Professor Krishna Narahari
Professor Rakesh Heer
Supported by
Cardiff and Vale University Health Board
University of Aberdeen
NIHR Health Technology Assessment (HTA) Programme
The Urology Foundation
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
