A trial using stereotactic radiotherapy to treat prostate cancer (SPORT)

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Cancer type:

Prostate cancer

Status:

Open

Phase:

Pilot

This trial is looking at whether a new targeted type of radiotherapy called SABR is a useful treatment for prostate cancer.

Some of the men taking part will have their lymph nodes Open a glossary item treated as well as their prostate gland and the others will not.

More about this trial

Radiotherapy, either with surgery or hormone therapy or on its own is the usual treatment for locally advanced prostate cancer. But there is still a risk of the cancer coming back or getting worse after treatment. 
    
Doctors want to see if it is better and safer to treat the prostate gland and lymph nodes with SABR. They also want to see if this will improve the way the radiotherapy is given.

The prostate organ moves with breathing. Doctors will place markers into the prostate so that the radiotherapy can target the prostate precisely. 

A type of gel called a spacer placement will also be put in at the same time above the back passage (rectum). This creates a space between the rectum and prostate to help reduce side effects.

The aims of the trial are to find out

  • if it is practical to give SABR radiotherapy to treat prostate cancer
  • if it is effective to treat lymph nodes with the prostate gland
  • what the side effects are

Who can enter

The following bullet points list 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. 

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

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

  • Have a prostate bigger than a volume of 90cc
  • Have prostate cancer that is stage T3b or higher
  • Might not respond to hormone therapy (castrate resistant)
  • Have any severe lower urinary tract symptoms, such as a feeling of incomplete bladder emptying, having to pass urine very often, having to pass urine suddenly, having to strain to pass urine, having to pass urine a lot at night
  • Are having chemotherapy or drugs as part of a clinical trial
  • Are having any surgery, or taking any drugs or treatment which may cause a problem with the hormone therapy or radiotherapy
  • Have had radiotherapy to your pelvis
  • Have had previous major surgery to your abdomen Open a glossary item
  • Have been diagnosed with any cancer in the last 5 years, apart from basal cell carcinoma
  • Have an autoimmune disease Open a glossary item 
  • Have had both hips replaced
  • Have excessive bleeding and your blood is unable to form clots
  • Take medicine to help your blood clot
  • Have any inflammatory bowel disease or any other long term bowel problem
  • Have had any scarring in your bowel (bowel adhesions)
  • Have any other serious uncontrollable disease
  • Are allergic to gold

Trial design

This is a pilot study.  There is a randomised and non randomised part in this study. The researchers need 30 people in the randomised part and 10 people in the non randomised part. 

Randomised 

In this part the people are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. 

•    One group have SABR radiotherapy to their prostate gland only
•    The other group have SABR radiotherapy to their prostate gland and lymph nodes

Diagram showing SPORT randomisation

You have treatment once a week for 5 weeks.

Non ramdomised

In this part everyone has SABR radiotherapy to their prostate gland and lymph nodes. You have treatment every other day (alternate days) for 2 weeks.

Everyone 

You have hormone therapy alongside the radiotherapy. This is usually an injection every 3 months but your doctor will discuss treatment choices with you. 

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include: 

  • a clinical examination of your chest and abdomen Open a glossary item
  • blood tests
  • a CT scan of the area between your hip bones (pelvis)

Before you start your treatment the doctors plan your radiotherapy

You also have fiducial markers put into your prostate and a spacer placement put above your rectum. A spacer placement is a gel which is placed above the rectum. It reduces the side effects from the radiotherapy. At the same time you have a prostate biopsy

You then have another CT scan and a MRI scan. The results of the CT scan help the doctors decide if you are able to go onto the trial. If not, you have standard radiotherapy

You have your 5  radiotherapy treatments at the hospital. 

For people in the randomised part you have them once a week over a total of 29 days. 

For people in the non randomised part you have your radiotherapy treatments every other day over 2 weeks. 

During the treatment you:

  • have a blood test before each treatment
  • have a blood test the day after the first treatment
  • give a urine sample after every treatment (for those in the randomised part only)
  • complete a questionnaire about your symptoms at every treatment

After your radiotherapy has finished you:

  • have a blood test at your follow up appointments
  • give a urine sample at your follow up appointments for the first 2 years after finishing radiotherapy (for those in the randomised part only)
  • complete short questionnaires about your symptoms at every visit
  • consider having a second prostate biopsy after you have finished the hormone therapy

People in the non randomised part see the doctor or get a phone from the team 2 weeks after finishing treatment. This is to see how you are and if there are any side effects. 

Side effects

The risks from fiducial markers, spacer placement and prostate biopsy include

  • bleeding
  • infection
  • pain
  • discomfort
  • blood in your urine and poo
  • blood in your semen

Feelings of pain and discomfort do not last long and you should feel better after taking simple painkillers. You should stop having blood in your urine and poo after a week. You will be given 2 antibiotic tablets straight after the procedure. You carry on taking these twice a day for 5 days.

The most common side effects from radiotherapy to your prostate and pelvis include

  • bladder problems which include having to pass urine more frequently and urgently, passing more urine overnight and finding blood in your urine
  • bowel problems which include changes in bowel habits and bleeding from the back passage
  • tiredness (fatigue)
  • inability to have an erection
  • skin reddening and itchiness
  • swollen legs 
  • pubic hair loss

We have more information about side effects of radiotherapy to the prostate.

Location

Belfast

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Suneil Jain

Supported by

Experimental Cancer Medicine Centre (ECMC)
Belfast Health & Social Care Trust
Friends of the Cancer Centre

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13878

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Keith took part in a trial looking into hormone therapy

A picture of Keith

"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”

Last reviewed:

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