"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”
A study looking at surgery for men with prostate cancer that has spread to the bones (TRoMbone)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is to find if removing the prostate gland can help men with prostate cancer that has spread to the bone only.
More about this trial
Hormone therapy is the usual treatment for prostate cancer that has spread to the bones.
Researchers think that having surgery to remove the prostate gland completely (radical prostatectomy) and hormone therapy might be better than hormone therapy only. But they aren’t sure.
To find this out, they need to do a large
- have standard care and surgery to remove their prostate
Before they can do a clinical trial they need to find out if it is possible to do one. This is called a feasibility study.
The aim of this feasibility study is to find how willing men are to take part.
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 prostate cancer that has spread to the bones
- You have a had a
scanthat shows there are only 1 to 3 areas of cancer spread to the bones
- Your cancer can be removed by surgery (stage T1 to T3)
- You are able to have surgery to remove the prostate within 12 months of starting hormone therapy
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1)
- You are between 18 and 74 years old
You cannot join this study if any of these apply.
- Your cancer has spread to other areas of the body
- You have more than 3 areas of cancer spread to the bones
- You aren’t able to have surgery to remove the prostate
- You have had radiotherapy to your tummy (abdomen) or the area between your hips (pelvis)
- You have had radiotherapy to the cancer spread in your bones
- You have had treatment for your prostate cancer that reaches your whole body, for example chemotherapy or hormone therapy, for 12 months or more
- You are already taking part in a clinical trial
This is a feasibility study. The team need 50 men to join.
It is a randomised study. You are put into 1 of 2 groups by a computer. Neither you or your doctor can choose which group you are in.
- 25 men have standard care
- 25 men have standard care and surgery to remove the prostate (radical prostatectomy)
You start hormone therapy by taking tablets for a month. You then have injections once a month or once a year. Your GP gives you the injections.
If you are in the group having surgery you have this within 12 months of starting hormone therapy.
Before surgery you have a general anaesthetic. Your surgeon will use keyhole surgery. This means having an operation without needing a major cut in your tummy (abdomen).
The surgeon makes 6 small cuts in your abdomen. Through these the surgeon uses the instruments to remove the prostate. The instruments are attached to a machine (robot) that the surgeon uses to control the instruments.
Sometimes it might not be possible to do keyhole surgery. The surgeon then makes one large cut at the bottom of your abdomen.
After surgery you are in hospital for up to a week depending on which surgery you had.
Quality of life
You fill in a questionnaire at the start of the study and 3 months after. The questions ask about your general health and any side effects you might have. This is called a quality of life questionnaire.
Tape recordings and interviews
The researchers will ask your permission to audio tape your visit with the doctor or research nurse when they talk about the study with you.
They will also invite some people for an interview to talk about their experience of the information session.
You don’t have to agree to either of these if you don’t want to. You can still take part in the main study.
Everyone sees the doctor to have a physical examination and blood tests before taking part.
If you are having hormone therapy you see the doctors after 3 months. This is part of routine follow up but as part of the study you will also be asked to complete a questionnaire and about any side effects you have.
If you are having surgery, you go to the hospital for a routine pre surgery assessment visit. This is to find out how fit you are to have surgery. You might have some tests including:
- blood tests
- heart trace (
- chest x-ray
Depending on the type of surgery you will be in hospital for up to a week after surgery.
Your surgeon will see you 6 weeks after surgery to see how you are. In most cases this visit will coincide with your 3 month follow up after starting hormone therapy. So as part of the study you will be asked to complete a questionnaire and about any side effects you have.
How to join a clinical trial
Dr Prasanna Sooriakumaran
Prostate Cancer Foundation
The Urology Foundation
University of Oxford
Surgical Intervention Trials Unit (SITU)