A study looking at further treatment for prostate cancer that has come back in the prostate after previous radiotherapy (RO-PIP)
Cancer type:
Status:
Phase:
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 
(EBRT) or . 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 . 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 comparing these 2 treatments. First, they need to know if men would be willing to go into such a trial. This is a .
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
Brachytherapy
Brachytherapy is internal radiotherapy. You have a 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 (), 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.
Location
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.
Chief Investigator
Dr Ann Henry
Supported by
Leeds Teaching Hospitals NHS Trust
Leeds Hospitals Charity
CRUK RadNet
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
