"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”
A trial comparing three operations for prostate cancer (LopeRA)
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Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing open surgery, keyhole (laparoscopic) surgery and robot assisted surgery for prostate cancer that has not spread. This trial is supported by Cancer Research UK.
Doctors usually remove localised prostate cancer with surgery. There are several ways to do this, and no one is quite sure yet which one is best.
Open surgery is when the surgeon makes a cut in the abdomen, or between the testicles and back passage, to remove the prostate.
Laparoscopic surgery is when the surgeon makes several smaller cuts and puts surgical instruments and a camera through these small holes. The surgeon uses these to look inside, find and remove the prostate.
Robot assisted surgery is similar to laparoscopic surgery. But the surgeon controls the instruments and camera using a machine (robot). It is sometimes called da Vinci surgery.
The research team will run a feasibility study first, to see if it is possible to recruit more patients into a larger trial.
The aims of the larger trial would be to find out more about
- How long each operation takes
- How long you stay in hospital
- The side effects
- What effect each operation has on quality of life
- If the cancer comes back after surgery
Who can enter
You can enter this trial if you
- Have prostate cancer that has not spread outside your prostate
- Have decided to have an operation to remove your prostate (a radical prostatectomy)
- Have a Gleason score of 7 or less
- Have a PSA level of 20 or less
- Are at least 18 years old
You cannot enter this trial if you
This is a feasibility study of a phase 3 trial. This means the trial team will recruit about 100 patients to begin with and if that goes well, they will go on to recruit more people in a large phase 3 trial. It is in 2 stages. In the first stage the trial team want to recruit 30 people in 6 months. In this stage they want to find out why people agree to take part in the trial and why they don’t. They will use this information to try and improve recruitment into the second stage. In the second stage they hope to recruit another 30 people in 6 months
This is a randomised trial. The people taking part are put into treatment groups using a computer. Neither you nor your doctor will be able to decide which group you are in.
- Group 1 will have key hole (laparoscopic) surgery
- Group 2 will have open surgery
- Group 3 will have robot assisted surgery
These operations are all specialist procedures. There may not be a surgeon at your local hospital who is an expert at the operation you are due to have. So you may have to go to another hospital for your operation. But the trial team have set up the trial so that there is an expert in each of the 3 operations working near each other. So which ever group you are in, you shouldn’t have to travel far.
You will fill out a questionnaire before you have surgery and then 6 times in the first year after your operation. This will ask you how you have been feeling and about any side effects you have had. It is called a quality of life study.
You will see the doctors and have some tests before you take part in this trial. The tests include
- Physical examination
- Blood tests
- An ultrasound via your rectum (trans rectal ultrasound scan, or TRUS)
- Chest X-ray
Heart trace (ECG)
You will go into hospital either on the day of your operation or the day before. How long you stay in hospital will depend on which operation you have, but it shouldn’t be more than about 5 days.
When you go home you will have a tube (catheter) into your bladder to drain urine. You will go back to the hospital to have this removed 1 to 2 weeks after your operation.
You will see the doctors and have a PSA test 6 weeks after your operation, and then every 6 months after that.
How to join a clinical trial
Professor Ara Darzi
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Imperial College London
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUK/09/008.