A study looking at further treatment for prostate cancer that has come back in the prostate after previous radiotherapy (RO-PIP)

Cancer type:

Prostate cancer

Status:

Open

Phase:

Other

This study is looking at the side effects of 2 different types of radiotherapy.

It is open to men with prostate cancer:

who have had previous external beam radiotherapy or brachytherapy
and the prostate cancer has come back in the prostate gland only

More about this trial

Doctors can treat prostate cancer with external beam radiotherapy Open a glossary item (EBRT) or brachytherapy . Unfortunately for some men their prostate cancer can come back in the prostate after treatment.

What the best treatment is for men in this situation is not known. It is possible to treat these men again with radiotherapy. And recent research suggests this might be better and have fewer side effects than other treatments such as surgery.

Doctors can use brachytherapy to treat prostate cancer that has come back in the prostate only. Brachytherapy is putting radiotherapy seeds into the prostate. To have brachytherapy you need to have a general anaesthetic Open a glossary item . But not all men can have a general anaesthetic.

A type of EBRT is stereotactic ablative radiotherapy (SABR). This targets the cancer more accurately than other EBRT. This means there could be fewer side effects. Researchers think that SABR might be as good as brachytherapy and have fewer side effects.

To find this out they need to do a large clinical trial Open a glossary item comparing these 2 treatments. First, they need to know if men would be willing to go into such a trial. This is a feasibility study .

The main aims of this feasibility study are to find out:

if it is possible to do a large phase 3 trial
more about the side effects
how the treatments affect quality of life

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:

have prostate cancer that has not spread out of the prostate (stage T1 to T3) and your most recent PSA level was less than 50ng/ml
had external beam radiotherapy (EBRT) or brachytherapy (BT) as your previous treatment
had previous prostate treatment at least 2 years ago
have a tissue sample (biopsy ) that shows your cancer has come back
have satisfactory blood test results
can pass water (urinate) well enough. Your doctor will do a test for this.
are able to have a general anaesthetic
are up and about for half the day, can look after yourself but might not be able to work (performance status 0, 1 or 2)
are at least 18 years old

Your doctor might want to start you on hormone treatment. If so, you must not start having it until you start treatment in this trial.

Who can’t take part

You cannot join this study if any of these apply. You:

have cancer spread to another part of the body (metastatic)
have had your prostate removed by surgery (prostatectomy)
have or had an inflammatory bowel disease such as irritable bowel syndrome or Crohn’s disease
have a narrowing of the urethra
are not able to have a biopsy taken from your prostate
are not able to have an MRI scan . This could be because you have metal such as a pacemaker in your body or don’t like small and confined spaces (claustrophobia).
have any other medical condition or mental health problem that affects your ability to give informed consent

Trial design

This is a feasibility study. The team aim to have 60 men take part in the study.

It is a randomised study. A computer puts you into 1 of 2 groups. Neither you nor your doctor chooses which group you go into. The groups are:

brachytherapy
SABR

Diagram 1

Brachytherapy
Brachytherapy is internal radiotherapy. You have a general anaesthetic Open a glossary item to have brachytherapy. You might need to stay in hospital overnight after treatment. This is so the healthcare team can monitor you after the general anaesthetic.

You might have 1 or 2 treatments of brachytherapy. Your doctor will tell you how many you are going to have. If you are having 2 treatments you have the 2nd treatment about 2 weeks after the first.

SABR
SABR is external radiotherapy. Before having SABR you have a planning appointment. This is so the team can work out accurately where to give the radiotherapy and how much to give.

You have 5 treatments over 2 weeks. You come in as an outpatient.

Quality of life
You fill in questionnaires before you start treatment and then after treatment at:

1 month
3 months
6 months
1 year
2 years

The questions ask about:

your general health and wellbeing
what daily activities you can do
side effects and symptoms

These are quality of life questionnaires.

Samples for research
The team take tissue samples (biopsies Open a glossary item ), blood samples and urine samples as part of the study. Your doctor will tell you when and how often you have these done.

Researchers use these samples to see how well treatment is working.

Hospital visits

You see the doctor to have tests before taking part. These include:

blood tests
urine test
mpMRI scan
PSA test

You see the doctor regularly during treatment. This is:

to see how you are
for blood and urine samples
to ask about side effects

After treatment you see the doctor at:

1 month
3 months
6 months
1 year
2 years

You have an MRI scan before your treatment and after treatment at 1 month and 1 year.

Your doctor will then tell you how often they want to see you.

Side effects

The study team monitor 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.

Brachytherapy and SABR and can affect the body organs surrounding the prostate such as the bowel and bladder.

Side effects of the bowel can be:

loose watery stool
needing to pass stool more often and urgently
passing mucus
blood in the stool
abdominal and bowel discomfort

Side effects of the bladder can be:

needing to pass urine more frequently and urgently. This can cause mild discomfort.
unable to pass urine

Radiotherapy can also affect your sex life. Your sexual activity can decrease a lot during treatment. A small number of men might recover their sexual activity after treatment. Older men have more difficulties than younger men.

Unfortunately, you are likely to lose the ability to father children.

We have information about the side effects of:

Your doctor will talk to you about the possible side effects of treatment. And they can answer any of your questions before you agree to take part.