A trial of stereotactic radiotherapy for prostate that has spread (STAR-TRAP)
Cancer type:
Status:
Phase:
This trial is looking at stereotactic radiotherapy to treat prostate cancer that has spread to another part of the body.
It is open to people:
- who have started the
standard treatment 
to treat prostate cancer that has spread and - whose cancer is currently active in a few areas in the body
More about this trial
One of the standard treatments for prostate cancer that has spread is hormone treatment. With the hormone treatment you will also have:
- an
anti androgen treatment such as enzalutamide, darolutamide or apalutamide - or abiraterone
You might also have a chemotherapy drug called docetaxel.
Stereotactic radiotherapy (also called SBRT or SABR) gives radiotherapy from many different angles around the body. The beams all meet at the cancer. We know that stereotactic radiotherapy works for other cancers where there is a small number of areas where the cancer has spread to.
Researchers think that stereotactic radiotherapy with the standard treatment might be better for people in this situation than standard treatment only.
The trial team will recruit 2 different groups of people. One group includes
people with who have been having hormone therapy for at least 6 months, but no more than 12 months. This group will have a scan to help doctors decide if they can continue into the treatment part of the trial.
The other group is for people:
- whose cancer is starting to grow (progress) with 5 or fewer areas of active cancer within the body, or
- who have active cancer within their prostate gland
This is called oligoprogressive disease.
In this trial, half the people will have the standard treatment only. The other half will have the standard treatment plus stereotactic radiotherapy.
The aims of this trial are to find out:
- how well stereotactic radiotherapy works with the standard treatment
- more about the side effects of stereotactic radiotherapy
- how this treatment affects
quality of life
Who can enter
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
| The entry conditions below apply to everyone who might be able to take part. There are 2 different groups in this trial. As well as the below, each group has its own entry conditions which your doctor or member of the trial team can tell you about. |
You may be able to join this trial if you are at least 18 years old and all of the following apply. You:
- have prostate cancer
- had more than 5 areas in the body where the cancer has spread to, when it was originally found
- are on
hormone therapy and you are taking abiraterone or an anti androgen treatment such as enzalutamide, apalutamide or darolutamide. This can be with or without docetaxel. - have blood tests to assess how your cancer treatment is working
- have recent scans that show you now have 5 or less areas where the cancer is active
- are able to have stereotactic radiotherapy. Your doctor will know this.
- can look after yourself, are up and about for most of the day but might not be able to work (performance status 0, 1 or 2)
Who can’t take part
You cannot join this trial if any of these apply. You:
- have an area of cancer spread that is bigger than 6cm. For an area in the lung it is 5cm.
- had another cancer in the past 3 years that got worse or needed treatment. If you have had a recent treated cancer, you may still be able to enter the trial.
- have
spinal cord compression or another condition where your doctor thinks you might need urgent radiotherapy (that is within 24 hours) to the spine. - have any other medical conditions that could affect you taking part. Your doctor will ask you about any medical conditions you have and will know if they could affect you taking part.
Trial design
There are 2 parts to this trial. The registration part and the treatment part. You might go into the registration part first before going on to the treatment part. Or you might go straight into the treatment part. Your doctor will explain this when they discuss the trial with you.
Registration
This is for people who are taking hormone therapies, with or without docetaxel. This is for at least 6 months but no more than 12 months. Your blood test must indicate the cancer is responding well. You will then have a PMSA PET-CT scan. This is a specialised scan for prostate cancer. The doctor will invite you to go into the treatment part if the results of the scan shows that:
- the treatment is working and
- you have 5 or fewer areas of active cancer in the body
This is called induced oligo-metastatic disease.
The team might ask if you are willing to take part in a sub study. In this sub study you have an extra scan, called a whole body MRI scan. You don’t have to agree to take part in the sub study.
If your scan results mean that you are not eligible, you won’t continue in this trial. Your doctor will discuss other possible treatment options with you.
This is a phase 2 trial. The team need about 236 people to take part. This includes:
- 176 people who joined the registration part and are eligible to move into the treatment part of the trial
- 60 people whose prostate cancer is starting to grow (progress) with 5 or fewer areas of active cancer spread in the body, or who have active cancer within the prostate gland
It is a randomised trial. A computer puts you into 1 of 2 treatment groups. Neither you nor your doctor will choose which treatment group you go into. These are:
- standard treatment
- standard treatment and stereotactic radiotherapy
Standard treatment
You continue having your hormone and anti androgen treatment.
Standard treatment and stereotactic radiotherapy
You continue to have your hormone and anti androgen treatment. You also have stereotactic radiotherapy to the areas of the body where the cancer has spread to.
Before your radiotherapy you have a planning appointment. This is to work out the dose of radiotherapy and exactly where you need it. You will have a CT planning scan. You might also have an MRI scan.
You might have small metal markers put in and around the cancer. This is to help target the cancer. Your doctor will explain more about the metal markers and how they are put in, if you need to have them.
You start radiotherapy treatment about 8 weeks after randomisation. You have the radiotherapy over 3 to 5 days on alternate days. There are different types of machines that give stereotactic radiotherapy. Depending on the machine, your treatment could take between 20 to 90 minutes.
You might also have radiotherapy to your prostate.
Your doctor will discuss more about your treatment when you see them.
Quality of life
Everyone fills in questionnaires. The questions ask about:
- your general health and wellbeing
- what daily activities you can do
- symptoms and side effects
People having standard treatment
You complete the questionnaires when you join the trial and then at:
- 10 weeks
- 20 weeks
- 6 months
- 9 months
- 12 months and then every
- 4 months up to 3 years
People having standard treatment with stereotactic radiotherapy
You complete the questionnaires when you join the trial, then at:
- the finish of radiotherapy
- 12 weeks
- 6 months
- 9 months
- 12 months and then every
- 4 months up to 3 years
These are quality of life questionnaires.
Hospital visits
You see the doctor before registering for or joining the trial. This is to discuss the trial with you.
During the trial you see the doctor as part of your regular follow up. Your doctor will tell you how often this is and what tests you might have. Tests might include blood tests and scans.
Side effects
The trial 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.
Your doctor will discuss the possible side effects of the treatments and answer any questions you have before you agree to take part in the trial.
The side effects of radiotherapy will depend on where you have the radiotherapy.
After radiotherapy you can have short term side effects and long term side effects. Short term side effects can happen during or soon after radiotherapy. Long term side effects can happen months or years after having radiotherapy.
General side effects of radiotherapy include:
- tiredness
- red, sore skin where you have the radiotherapy, this is rare and temporary
We have information about:
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 Julia Murray
Supported by
Prostate Cancer UK
Institute of Cancer Research (ICR)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
