A study looking at increasing the dose of radiotherapy to areas of cancer inside the prostate gland (DELINEATE)

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 study is looking at new ways of planning and giving radiotherapy for prostate cancer. It is for men who have localised prostate cancer and their doctors think there is a medium (intermediate) or high risk of it growing or spreading.

More about this trial

When doctors treat localised prostate cancer with radiotherapy, they usually give the same dose to the whole prostate gland. This is because it can be very difficult to see the difference between cancer and normal prostate tissue on a scan. But new types of MRI scans are more accurate. Using these, along with modern radiotherapy equipment, doctors can now identify and target areas of cancer in the prostate.

In this study, researchers are using intensity modulated radiotherapy (IMRT) to plan radiotherapy, and image guided radiotherapy (IGRT) to give treatment very accurately. This will allow them to give a higher dose of radiotherapy to the cancer, while giving the standard dose to the rest of the prostate gland.

The aims of the study are to

See if this type of treatment is possible
Learn more about the side effects

Who can enter

You may be able to enter this study if:

You have been diagnosed with localised prostate cancer, are being treated at the Royal Marsden Hospital (Sutton branch) and your doctors think there is a medium or high risk of your cancer growing or spreading
Doctors can see your cancer using an MRI scan
You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
You have satisfactory blood tests results
You are at least 18 years old

You cannot enter this study if you

Have cancer that has spread to other body organs
Have a PSA level of 50 or over
Have already had radiotherapy to your prostate gland or to the area between your hip bones (your pelvis )
Have had surgery to remove your prostate gland (a radical prostatectomy)
Have had any other type of cancer in the last 5 years, apart from non melanoma skin cancer
Can’t have MRI scans for example, because you have some metal in your body, or have a pacemaker
Have had both your hips replaced
Have any other medical condition (or have had any other treatment) that the doctors think could make the side effects of radiotherapy worse
Take medication to thin your blood (anticoagulants) and you would not be able to stop taking this for about a week
Had an infection or a lot of bleeding after having a biopsy of your prostate

Trial design

The study will recruit 320 men who are having treatment at the Royal Marsden Hospital, Sutton.

If you agree to join the trial, you start by having an MRI scan. During this scan, you have a small magnetic coil put inside your back passage. This makes the scan more accurate.

You then start hormone therapy to lower the testosterone Open a glossary item level in your body. This can help to shrink your prostate gland and the cancer. You have tablets for 1 to 2 weeks and then an injection. The study team will give you more information about this, but having hormone therapy alongside radiotherapy is a standard treatment for prostate cancer.

A radiologist will study the images from your MRI scan. If they can clearly see an area of cancer (a nodule) inside your prostate gland that they can target with a higher dose of radiotherapy, you can continue in the study. If they cannot see a nodule clearly, you will have standard radiotherapy.

If you continue in the study, the researchers need to put some small gold seeds into your prostate gland – they are about the size of a grain of rice. They put the seeds in during a transrectal ultrasound. This is similar to the prostate biopsy that you would have had to diagnose your cancer. To lower the risk of infection, you take antibiotics for a few days before and after the seeds are put in. And if you take drugs to thin your blood (anticoagulants), the study team will ask you to stop taking them 5 to 7 days beforehand.

At least 5 days after having the gold seeds put in, you have another MRI or CT scan to plan your radiotherapy. You do not have the coil put in this time. You may have a thin tube called a catheter put into your bladder through your penis. This is to make sure that the area of the prostate gland getting the higher dose of radiotherapy doesn’t include the tube that carries urine out of the body (the urethra).

You start radiotherapy about 3 weeks after your planning session. Each time you have treatment, the study team take images to check the position of your pelvis and the location of the gold seeds in your prostate gland. Checking this will make each radiotherapy session about 5 minutes longer.

The team will ask everybody taking part to fill out some questionnaires during the study and at follow up appointments. They will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

Hospital visits

Before you can join the study, you see the doctors and have some tests. The tests include

Physical examination
CT scan or MRI scan
Bone scan
Blood tests, including a PSA test

The first MRI scan will take 40 to 50 minutes, as you have some of the scan with the coil inside your back passage and some without the coil in place.

You have the gold seeds put in at the Sutton branch of the Royal Marsden Hospital. It takes between 15 and 30 minutes.

You have your radiotherapy planning session at the Sutton branch of the hospital.

You go to hospital every day for 4 weeks for radiotherapy. You see the study team

Every 2 weeks during radiotherapy
After you finish radiotherapy and again 8 weeks later
Then after 6 months, 1 year, 18 months and 2 years

Side effects

Having gold seeds put in to your prostate gland can be uncomfortable. If you wish, you can have some local anaesthetic Open a glossary item . The gold seed markers are not removed after treatment and will not cause you any problems in the future.

As the study team will take X-rays each day to check the position of your prostate gland, taking part in the study will mean that you are exposed to more radiation. This could increase your risk of getting another cancer in the future. The amount of extra radiation is very small (about 2% of your treatment dose) and the study team thinks the risk is outweighed by the benefit of having your treatment planned accurately.

It is possible that men taking part in this study may have more radiotherapy side effects, but the researchers think this is unlikely.

We have more information about side effects of prostate cancer radiotherapy.