A trial looking at new ways to improve treatment for prostate cancer that has spread (STAMPEDE2)
Cancer type:
Status:
Phase:
This trial is looking at adding certain treatments to hormone treatment for prostate cancer that has spread to other parts of the body.
Cancer Research UK supports this trial.
More about this trial
Prostate cancer that has spread to another part of the body is called metastatic prostate cancer. The current best treatment for metastatic prostate cancer is a combination of several different treatments used together. Everyone has hormone therapy as injections or tablets. These stop your body making testosterone. You might hear these treatments referred to as androgen deprivation therapy (ADT). In addition to ADT, some people might also have 
, docetaxel chemotherapy or both.
Most people also have additional hormone treatment in the form of a tablet. Examples of additional hormone treatments are the drugs abiraterone, enzalutamide, darolutamide or apalutamide. These drugs block testosterone from reaching the cancer cells. Altogether, these treatments are referred to as the standard of care.
Doctors are looking at ways to improve treatment for prostate cancer that has spread. In this trial they are looking at:
- a type of radiotherapy called stereotactic ablative body radiotherapy (SABR)
- a type of internal radiotherapy called PSMA-Lutetium (177Lu-PSMA-617)
Stereotactic ablative body radiotherapy is a type of external radiotherapy. A machine directs radiation at the cancer from outside of the body. It gives radiotherapy from many different angles around the body and the beams meet at the tumour. This means the tumour gets a high dose of radiation and the tissues around it get a much lower dose. This lowers the risk of side effects. It is widely used for a range of cancers, including prostate cancer that has come back after initial therapy.
PSMA-Lutetium is a type of internal radiotherapy. Internal radiotherapy means giving radiotherapy to the cancer from inside the body. You have PSMA-Lutetium as a drip into a vein. Once inside the body, the therapy targets a protein called prostate specific membrane antigen (PSMA). PSMA is overproduced in prostate cancer cells. So PSMA-Lutetium targets radiation to the prostate cancer cells. This means that the cancer cells get a high dose of radiation which can destroy them. And healthy cells get a low dose or no radiation.
In this trial, everyone has standard of care treatment. And some people also have the trial treatments.
The main aims of this trial are to find out:
- if adding these treatments works better than standard of care alone
- what the side effects are
- how 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.
Who can take part
Registration part
You may be able to register for this trial if all of the following apply. You:
- have
adenocarcinoma of the prostate or your doctor suspects this and you are having tests to confirm this before you are put into a treatment group. This is normally confirmed by a tissue sample (biopsy ). - have newly diagnosed prostate cancer or you have prostate cancer that has come back. If you have prostate cancer that has come back you must have stopped taking hormone treatment more than 2 years ago and had it for less than 3 years.
- have started having long term hormone treatment or the plan is for you to start this and have it for at least 2 years. Your doctor will know about this.
- have cancer that has spread to other parts of the body that your doctor can see on a CT scan, an MRI scan or a bone scan. Your doctor checks where exactly it has spread to and how big it is to see if you are suitable for the trial.
- are up and about for at least half the day but might not be able to work (performance status 0, 1, 2 or 3). If you are performance status 3, you might need some help looking after yourself but your doctor thinks this will improve when you start hormone treatment.
- are at least 18 years old
Treatment part
STAMPEDE2 is a large trial that is actually two smaller trials rolled into one. Each smaller trial is called a comparison. These are comparison S and Comparison P.
Your doctor will talk to you about the comparison they think you might be suitable for.
| As well as the general entry conditions for registration into the whole trial, the following must also apply for entry into each comparison. |
To join this comparison the following must apply. You:
- have newly diagnosed prostate cancer and you are suitable to have
stereotactic ablative body radiotherapy - have cancer that has spread to 1 to 5 areas in the
lymph glands outside of the pelvis, to the bones or both - have started initial hormone therapy and you join the comparison within 12 weeks of this
PSMA-Lutetium (177Lu-PSMA-617) (Comparison P)
To join this comparison the following must apply. You:
- have cancer that can’t be treated with stereotactic ablative body radiotherapy
- have cancer that has spread to more than 5 areas in the
lymph glands outside of the pelvis, to the bones or to other parts of the body - have started initial hormone therapy and you join the comparison within 12 weeks of starting this
- stopped having hormone treatment more than 2 years before joining a comparison if you have prostate cancer that has come back. You must not have had the hormone treatment for more than 3 years in total and your cancer didn’t get worse within 12 months after having it.
- have satisfactory blood and general fitness test results
For both comparisons, the following must also apply. You:
- have confirmed adenocarcinoma of the prostate
- are up and about for at least half the day but might not be able to work (performance status 0, 1 or 2)
- are willing to use reliable contraception during research treatments
Who can’t take part
Registration part
You cannot register for the trial comparisons if any of these apply. You:
- have pure small cell cancer of the prostate
- have cancer that has spread to the brain or spinal cord or the tissues that surround them
- have another cancer that is getting worse or needed treatment in the last 3 years. You can take part if you have non muscle invasive bladder cancer,
non melanoma skin cancer or another cancer that has a low risk of coming back. - have any other medical condition that means you aren’t suitable to have long term hormone treatment or any of the trial treatments
| As well as exclusions for the registration part, the following must also apply for the treatment part. |
Stereotactic ablative body radiotherapy (Comparison S)
You cannot join this comparison if any of the following apply. You:
- have prostate cancer that has come back
- have had surgery to remove the prostate, radiotherapy to the prostate or both
- have cancer that has spread to the brain
- have had treatment to the areas of cancer spread that include radiotherapy, surgery or
radiofrequency ablation - have
spinal cord compression or a trapped spinal cord and you might need urgent radiotherapy or surgery to treat it - have any other medical condition that could affect having stereotactic radiotherapy
- have had another cancer in the last 3 years
PSMA-Lutetium (177Lu-PSMA-617) (Comparison P)
You cannot join this comparison if any of the following apply. You:
- have had Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or a treatment similar to PSMA-Lutetium (177Lu-PSMA-617) in the past. Your doctor will know this.
- have spinal cord compression that is causing symptoms or your doctor thinks you are developing this. You might be able to take part when this has been safely managed.
- can’t raise your arms. You ned to be able to raise your arms for the scans you have.
- can’t control passing urine or you have a blocked
urethra that can’t be treated
Trial design
This is a phase 3 trial. The trial team need about 3,500 men to take part.
The team are comparing standard of care on its own with standard of care and one of the following:
- a type of radiotherapy called stereotactic ablative body radiotherapy (SABR)
- a new type of internal radiotherapy called PSMA-Lutetium (177Lu-PSMA-617)
Your doctor will tell you about which part of the trial you might be suitable to join.
Standard of care treatment
Your doctor will talk to you about the standard of care treatments, as described above.
You might also have docetaxel chemotherapy, radiotherapy or both. This depends on your cancer. Not everyone will be suitable for it or need to have it.
Your doctor will talk to you about these treatments and which ones you will have. They will also tell you how often you have them and for how long.
Stereotactic ablative body radiotherapy (comparison S)
You are put into a treatment group at random. Neither you nor your doctor can decide which group you are in. You and your doctor will know which treatment you are having.
There are 2 groups. You will have one of the following:
- standard of care
- standard of care treatment and stereotactic ablative body radiotherapy (SABR)
You have standard of care treatment as described above.
You have 3 to 5 treatments with SABR. You have treatment every other day. This takes about 1 to 2 weeks.
Everyone has a radiotherapy planning session before starting treatment. Your doctor can tell you more about this.
PSMA-Lutetium (177Lu-PSMA-617) (Comparison P)
You are put into a treatment group at random. Neither you nor your doctor can decide which group you are in. You and your doctor will know which treatment you are having. There are 2 groups. You have one of the following:
- standard of care
- standard of care and PSMA-Lutetium (177Lu-PSMA-617)
You have standard of care treatment as described above.
You have PSMA-Lutetium as an injection into a vein. You have that last 6 weeks. You will have 3 cycles of treatment in total. In each cycle you have:
- PSMA-Lutetium on day 1
- PSMA-Lutetium on day 8 and then
- no PSMA-Lutetium treatment for 5 weeks
You have 6 doses of treatment in total. This takes about 18 weeks but it could be a bit longer if you have side effects.
You can only have this treatment in a small number of centres across the UK. So you might need to travel to a hospital that offers this treatment. Your doctor can tell you more about this.
Samples and scans for research
The researchers ask everyone taking part if they can look at a sample of tissue that was taken when you were diagnosed. They also ask to take some extra blood samples for some people in Comparison P. Where possible, you will have these at the same time as your routine blood tests.
They plan to use the samples to:
- see how well the treatment is working
- look at
genes to understand more about prostate cancer - look for substances called
biomarkers to help work out why treatment might work for some people and not for others - learn more about the causes of prostate cancer
You don’t have to agree to collection of your tissue, scans or blood samples being stored and studied by the trial team. This research is very important to help understand why treatments do or do not work but you can still take part in the trial without agreeing to this.
Quality of life
The trial team ask everyone to fill out some questionnaires:
- before you start treatment
- at set times during and after treatment
The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study. The trial team encourage you to complete these questionnaires on your computer, phone or tablet device. This means they can be sent directly to you by email or text. If you prefer to complete these questionnaires on paper in clinic then the research team can help you with this.
Hospital visits
You see the doctor for a have some tests before you can take part in the trial. These may include:
You will see the doctor regularly during treatment. This is to see how you are and for blood tests. At the end of your treatment, you will see the doctor for some of the same tests you had at the start.
Follow up
When you finish treatment, you will have regular check ups with your doctor. How often you have check ups depends on the routine follow up care at your hospital. The team will tell you more about this.
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.
Having standard of care treatment in combination with the trial treatments is new. So we don’t know what all the side effects are.
The side effects of stereotactic body radiotherapy (SABR) include:
- short term tiredness
- mild skin changes at the treatment site
- some pain at the treatment site for a few days afterwards
The most common side effects of PSMA-Lutetium (177Lu-PSMA-617) include:
- a drop in the number of blood cells causing an increased risk of tiredness and breathlessness, bruising and bleeding
- dry mouth
- constipation or diarrhoea
- feeling or being sick
- tiredness
- loss of appetite
- pain at the site of where the cancer is
- a risk of a long term drop in kidney function. You have scans and tests to help work out who might be at risk of this.
After the treatment, some radiation may be present in your wee (urine) and poo (stool). The total amount is extremely small and gets lower each day. The team looking after you might ask you to take some precautions. A summary of these include:
- drinking a lot of fluid on the day you have treatment so that you can pass a lot of urine
- remaining in isolation at the hospital for as long as required by the team (this is on the day of treatment)
- avoiding close contact with those you live with for 2 to 3 days. It’s 7 days for children and anyone who is pregnant.
- washing your clothes that contain sweat, blood or urine separately from the laundry of other members of your household. They should be washed 2 or 3 times in a washing machine.
- flushing and cleaning the toilet after you have used it
We have more information about the following treatments and their side effects:
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
Professor Nick James
Professor Gert Attard
Supported by
University College London
Medical Research Council (MRC) Clinical Trials Unit at UCL
Cancer Research UK
Medical Research Council
Advanced Accelerator Applications (ADACAP) Novartis
Johnson & Johnson (provided funding during trial setup period)
Other information
There is more information about the trial on the STAMPEDE2 trial website.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
