A trial of stereotactic body radiotherapy for prostate cancer (HERMES)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Prostate cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at giving radiotherapy in fewer, higher doses for prostate cancer.

It is comparing having either 5 treatments over 10 days or 2 treatments over 8 days.

The trial is for men who have prostate cancer that is newly diagnosed and hasn’t spread.

More about this trial

Radiotherapy is a treatment option for prostate cancer. Researchers want to find the best way to give radiotherapy with the aim to cure that has the fewest side effects. In this trial they are looking at stereotactic body radiotherapy (SBRT).

SBRT directs radiotherapy beams at the cancer from different positions around the body. It is an accurate way to deliver a high dose of radiotherapy to the prostate in a smaller number of doses.

The team running this trial know that 5 treatments of SBRT works. Now they want to see if having 2 treatments at a higher dose works. This is possible with internal radiotherapy Open a glossary item . This involves having an anaesthetic and needles being inserted into the prostate. So the team want to see if can they give 2 doses of radiotherapy in a less invasive way, with SBRT.

The main aims of the trial are to find out:

if it is safe to have 2 large doses of SBRT to the prostate
if it is better to have 5 treatments or 2 treatments of SBRT
more about the side effects

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

You may be able to join this trial if all of the following apply. You:

have adenocarcinoma of the prostate and you are due to have radiotherapy with the aim to cure it
are male or a trans woman. You can’t take part if you are a trans woman and have had some types of gender reassignment surgery. Your team can explain more.
have prostate cancer that may have broken through the capsule (covering) of the prostate gland but it hasn’t spread any further. This is stage T3a cancer.
have a Gleason score that is no more than 3+4 or 4+3. Your doctor will know this.
have a PSA level that is less than 25 before starting hormone therapy
are having standard hormone treatment for at least 6 months but no more than 12 months
are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
are willing to fill in some questionnaires asking how you are feeling and to rate your quality of life
are willing to use reliable contraception during the trial and for a period after if there is any chance your partner could become pregnant
are at least 18 years old

Who can’t take part

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

have moderate to severe problems passing urine
can’t empty your bladder properly. You have a scan to check this.
have had one or both hips replaced or you have metal implants in the area between your hip bones (pelvis)
have had radiotherapy to the pelvis in the past
are going to need to have 2 to 3 years of hormone therapy
can’t have an MRI scan for any reason, for example you have a pacemaker, certain mobile metal implants or you are afraid of small spaces
have had another cancer in the last 2 years. This doesn’t include non melanoma skin cancer , low risk bladder cancer that hasn’t grown into the muscle wall or small growths on the kidney that you are having regular check ups for
have another medical condition that may cause you to have more side effects from radiotherapy such as inflammatory bowel disease

Trial design

This is a phase 2 trial. It is taking place at the Royal Marsden NHS Foundation Trust in Sutton. The team need 46 people to take part.

It is a randomised trial. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. There are 2 treatment groups.

You have 1 of the following:

5 SBRT treatments over 10 days
2 higher doses of SBRT over 8 days

HERMES trial randomisation diagram

Radiotherapy
The radiographer Open a glossary item takes some scans of your prostate before and during each treatment. This is to make sure that the SBRT is as accurate as possible.

You have the radiotherapy via a new radiotherapy machine. This is called an MR linac (Magnetic Resonance Linear Accelerator). It puts together an MRI scanner with a radiotherapy treatment machine called a Linear Accelerator.

Using the MR linac means you don’t have extra radiation that you have if you have CT scans Open a glossary item or x-rays. It lets the team adapt or ‘tweak’ the radiotherapy plan each day if they need to. This helps to target the prostate more precisely.

Each session takes about 45 to 60 minutes. Some people find the bed is quite hard. This is a picture of the MR linac machine.

Photo of the MR-linac machine

The team hope to look at 2 doses of SBRT in a large group of people. First they need to run this small trial to see if having 2 doses of SBRT works.

Hormone therapy
You also have hormone therapy. This is standard treatment and you would have this if you weren’t in the trial.

You start hormone therapy before radiotherapy begins and continue afterwards. You may have already started this treatment. Your doctor can tell you more about hormone therapy, the type you will have and how long you have it.

MOMENTUM study
The team will ask you to join the MOMENTUM study. MOMENTUM is an international registry to collect information and scan images on all people being treated on the MR linac machine. This means that researchers can help each other to learn faster about any possible benefits of the MR-linac.

You do have to take part in MOMENTUM to take part in this trial. MOMENTUM captures your treatment information. It does not add anything extra to this trial.

MRI scans and tissue samples for research
The team also ask you to have 3 extra MRI scans. You have these:

before you start radiotherapy
2 weeks after you finish radiotherapy
3 months after you finish radiotherapy

The team want to see if there is a link between what the prostate looks like on a scan and how well treatment worked. They also take some extra images while you are having treatment.

These scans won’t benefit you. They will help the team to learn more about prostate cancer and hopefully improve treatment for people with prostate cancer in the future.

The team also ask for a sample of cancer tissue Open a glossary item (biopsy) from when you were first diagnosed. They plan to look for gene changes in cancer cells. They may also use the samples in future research.

You don’t have to agree to have the extra scans or give permission for the tissue sample. It won’t affect you taking part in the rest of the trial.

The team might also ask you to give some extra blood samples. This is to see how radiotherapy affects the immune system Open a glossary item . You don’t have to give the extra blood samples if you don’t want to.

Quality of life
The trial team ask you to fill out questionnaires:

before you start treatment
at set times during treatment

The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see a doctor and have some tests before you take part in this trial. These may include:

physical examination
blood tests
a check to see you are suitable to have MRIs

If you are suitable to take part you also have some scans to plan your SBRT. These include a CT scan and an MRI scan. Your planning session is normally a separate appointment and takes about 30 minutes.

You have your radiotherapy at the hospital.

Follow up
When you finish radiotherapy you see the doctor or they call you to see how you are at:

2 weeks
1 month
2 months
3 months
6 months
1 year
2 years and then
once a year for up to 5 years after you finish radiotherapy

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.

We know about the side effects of standard radiotherapy. SBRT is not standard of care in the UK. So there may be some side effects we don’t know about yet.

Recent research suggests that people who have 5 SBRT treatments have similar short term side effects to people having standard radiotherapy. This is 20 to 39 treatment sessions.

We have included a list of side effects people have after standard radiotherapy treatment. The most common side effects during and soon after radiotherapy treatment are: