A study looking at a device to help reduce side effects from prostate cancer radiotherapy after surgery (POPS)

Cancer type:

Prostate cancer

Status:

Open

Phase:

Phase 2

This study is looking at a device called ProSpare to see if it can reduce the side effects from prostate cancer radiotherapy after surgery. 

It is for men who have had surgery to remove their prostate and who are going to have radiotherapy to the area where the prostate used to be (prostate bed).

More about this trial

Men with prostate cancer often have treatment with surgery and radiotherapy. But there can be side effects from prostate radiotherapy. Some of the most common problems affect the back passage (rectum) and can include:

  • pain
  • bleeding
  • an increase in the amount of times you have to poo
  • having to rush to go to the toilet (urgency)  

This can happen because the rectum is right next to the prostate bed and so it is impossible to avoid the rectum when having radiotherapy. Doctors try to avoid the rectum as much as possible. 

The researchers in this study have developed a device called ProSpare. They think it can help to identify the prostate bed and direct the radiotherapy to it. This should make the radiotherapy more accurate. 

ProSpare is a device about the size of a thumb. You put the ProSpare into your rectum before having radiotherapy and remove it afterwards.  

In this study, men have 1 of the following:

  • radiotherapy
  • radiotherapy with ProSpare 

The main aims of this trial are:

  • find out if ProSpare can help to reduce the side effects of prostate bed radiotherapy
  • find out if ProSpare can increase the accuracy of prostate bed radiotherapy
  • find out more about the side effects that men having prostate bed radiotherapy have

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
  • You have had surgery to remove your prostate (radical prostatectomy)
  • You are going to have radiotherapy to the area where your prostate was (prostate bed) 
  • Your anal muscles are working well
  • You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You are at least 18 years old

You cannot join this study if any of these apply.

  • Your prostate cancer has spread to the lymph nodes or other parts of the body (metastatic prostate cancer)
  • You have had radiotherapy to your pelvis (pelvic radiotherapy Open a glossary item)
  • You have had another cancer in the past 3 years apart from non melanoma skin cancer Open a glossary item
  • You have had chemotherapy within 6 weeks of starting radiotherapy
  • You are going to have chemotherapy within 2 months of finishing radiotherapy
  • You have haemorrhoids, problems in your anus or with your mobility that could affect the insertion of ProSpare
  • You have problems with your bladder or bowel (such as urinary incontinence Open a glossary item or inflammatory bowel disease) that could affect you taking part

Trial design

This is a phase 2 study. The researchers need about 245 men to take part. 

This trial is randomised. The men taking part are put into 1 of the following 2 groups by a computer:

  • radiotherapy
  • radiotherapy with ProSpare

    Neither you nor your doctor can choose which group you are in.

POPS study diagram

Radiotherapy
Everyone has radiotherapy. Your doctor can tell you how many treatments you will have. 

You usually have it once a day, Monday to Friday. It takes about 10 minutes each time. 

ProSpare
Your doctor will show you how to insert ProSpare. You also have a leaflet with instructions to guide you. The doctor will check that you are able to insert ProSpare and that it is comfortable.

You put ProSpare into your back passage (rectum). Then you have radiotherapy. This takes about 10 minutes. After radiotherapy you remove ProSpare.

You repeat this every radiotherapy treatment. Your doctor can tell you how many radiotherapy treatments you need.

Quality of life 
Everybody taking part in this study will be asked to complete quality of life questionnaires:

  • before starting radiotherapy
  • at set times during radiotherapy
  • at the end of radiotherapy treatment
  • at set times for up to 5 years after radiotherapy 

It asks about how your bowels and bladder are working and if the treatment has affected your ability to have sex. 

For the first 6 months the questionnaires will be given to you when you attend hospital for clinic appointments. After 6 months, the study team will send you the questionnaires in the post with a prepaid envelope.

Hospital visits

You see the doctor before taking part in this study. And you will have some tests before starting radiotherapy. Your doctor can tell you what tests you need. It includes:

  • blood tests (including a PSA level Open a glossary item)
  • a rectal examination Open a glossary item

You may have some extra x-rays if you are in the ProSpare group. You have them during your radiotherapy treatment to check that your prostate bed is in the correct position every day. It is a small amount of extra radiation and the researchers don’t think this will cause any problems to your health.

You see the study doctor every 2 weeks while you have radiotherapy. This is to check how you are and what side effects you may have. 

After radiotherapy, you see the trial doctor after:

  • 10 weeks 
  • 18 weeks
  • 6 months 
  • then every 6 months for 2 years

Side effects

You won’t have any side effects from using ProSpare but you might have side effects from the radiotherapy.

Location

Sutton

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor David Dearnaley

Supported by

Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
Sussex Development Services LLP 
The Royal Marsden NHS Foundation Trust

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13711

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Keith took part in a trial looking into hormone therapy

A picture of Keith

"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”

Last reviewed:

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