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A study looking at reducing side effects of prostate cancer radiotherapy (ProSpare II)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
More about this trial
Doctors often treat prostate cancer with radiotherapy. As with all treatments, there are side effects. One of the main side effects of prostate radiotherapy is inflammation of the back passage (proctitis). Doctors use techniques, such as
The researchers have developed a device called ProSpare that could help increase the accuracy of radiotherapy to the prostate. They also think it could push some of the back passage out of the way of the radiotherapy. By doing this they hope it could reduce inflammation of the back passage.
The aims of this study are to find out if using ProSpare can help increase the accuracy of giving radiotherapy to the prostate and so decrease the side effects to the back passage.
Who can enter
You may be able to enter this study if you are attending the Royal Marsden Hospital and you
- Have prostate cancer
- Are able to have radiotherapy to try and cure your cancer (radical radiotherapy)
- Have satisfactory blood test results
- Are at least 18 years old
You cannot enter this study if you
- Have already had radiotherapy to your prostate or the area between your hip bones (pelvis)
- Have had an operation to remove your whole prostate gland (radical prostatectomy)
- Have had surgery to replace one or both of your hip bones
- Have had another cancer in the last 5 years apart from non melanoma skin cancer
- Are taking medication to stop your blood from clotting – you may be able to take part if your medication can be stopped for a short period of time
- Have another bladder or bowel condition that could affect you taking part in this study
This is a pilot study. It will recruit 30 men who attend the Royal Marsden Hospital. It is a randomised study. You will be put into 1 of 2 groups. Neither you nor your doctor can choose which group you are in.
Every man taking part in this study will have radiotherapy and use the ProSpare device. ProSpare is a device about the size of a thumb. You put it into your back passage (rectum) before having radiotherapy and remove it afterwards.
Men in group 1 will use ProSpare for the first half of their radiotherapy. Men in group 2 will use ProSpare for the second half of their radiotherapy.
When you attend the clinic the doctor will show you how to put ProSpare in place. They will also check that having it in place is comfortable for you before going any further with the study. You will have an instruction leaflet on how to put it in.
As a part of this study you will have very small beads of gold, called gold seeds, put into your prostate. Having the gold seeds in your prostate makes it easier to be seen when you have radiotherapy. Putting them in is similar to having your prostate needle biopsy done.
The researchers will ask you to fill in a questionnaire. This will ask you how comfortable you felt using ProSpare and for any other comments you have.
You see the doctor and have some tests before taking part in this study. These tests can include
- A physical examination
- Digital rectal examination (DRE)
- Rectal ultrasound (TRUS) and needle biopsy
- Blood tests
- PSA blood test
During radiotherapy you see the doctor or nurse every 2 weeks to see how you are and if you have any side effects from the radiotherapy.
After treatment, you see the doctor 18 weeks after starting radiotherapy for a DRE and PSA blood test. You then see the doctor every 6 months for 2 years for the same and a physical examination.
As you have more radiotherapy treatments you may feel discomfort inserting or using ProSpare. If it becomes too uncomfortable you can stop using it and continue having radiotherapy without it.
After having the gold seeds put in you may have some blood in your urine, stool or semen for a few days. There is a small risk of getting an infection but you have antibiotics to reduce the risk.
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.
Prof David Dearnaley
Cancer Research UK
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
The Royal Marsden NHS Foundation Trust