A trial comparing the outcomes of different treatments for prostate cancer (CHRONOS A)

This is a phase 2/3 trial. In total the researchers need 1,190 men to join. 

There are 2 stages to CHRONOS A. 

In the 1st stage the team need 60 people to join. This is a pilot study to find out whether people are willing to join the trial and be put into the different treatment groups. 

In this part when you see your doctor to talk about the trial a member of the research team will ask to record the appointment on audio tape.  

The research team member might also ask to interview you. The team will arrange this at a time and place convenient for you. 

You don’t have to agree to your appointment being taped or to the interview if you don’t want to. You can still take part in the trial. 

You can agree to have your appointment being taped or to the interview but not take part in the study if you don’t want to. 

The 2nd stage of CHRONOS A will open if stage 1 is successful. 

Those who do join part 1 continue into part 2. 

In the 2nd stage of CHRONOS A the team need a further 1,130 men to join. 

This is a randomised trial. You are put into a treatment group. Neither you nor your doctor can choose which group you go into. There are 2 groups:

• radical therapy 
• focal therapy

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Radical therapy
You have 1 of the following treatments:

• external beam radiotherapy
• brachytherapy
• prostatectomy

External beam radiotherapy (EBRT) uses high energy beams similar to x-rays to destroy cancer cells. A machine directs these beams at the cancer. Before your treatment the team plan very carefully where to direct the beams and how much radiotherapy you need. You have treatment Monday to Friday. 

Brachytherapy is a type of internal radiation therapy. It is when a radioactive source is put inside the prostate. It then releases radiation to destroy the prostate cancer cells. The source is also known as seeds or pellets. These might stay inside your prostate permanently. Or your radiographer or doctor will remove them after treatment. 

You have brachytherapy as a day case and it takes 1 to 3 hours. You might have a local anaesthetic or a general anaesthetic . 

Prostatectomy is surgery to remove all your prostate gland. This might include removing the surrounding lymph glands . You have a general anaesthetic. You stay in hospital for 1 or 2 nights after surgery. 

Focal therapy
You have 1 of the following treatments:

• HIFU 
• cryotherapy 

HIFU is high intensity focussed ultrasound. HIFU uses high frequency sound waves targeted at the cancer cells. The waves create heat that destroys the cancer cells. 

To have the treatment you have an ultrasound probe put into your back passage (rectum). This probe gives out high intensity ultrasound energy that can destroy the cancer cells in your prostate. The high intensity ultrasound energy travels through the back passage to the prostate. 

You have HIFU as a day case. It takes about 1 to 3 hours. You have a general anaesthetic so you're asleep. At the start of treatment you have a tube (urinary catheter) put into your bladder through the hole in your penis. This might stay in for up to a week to drain urine from your bladder. A nurse will show you how to care for the catheter if you do go home with it.  

Cryotherapy uses extreme cold to destroy cancer cells. The doctor puts thin needles into your prostate. The needles go in through the area between your anus and testicles (perineum). They then pass a special gas down the needles into your prostate. 

You have cryotherapy as a day case. It takes 1 to 3 hours. You have either anaesthetic put into the fluid around your spinal cord  (spinal anaesthetic) or a general anaesthetic.

Before they start the cryotherapy treatment your doctor puts a tube (warming catheter) in through the hole in your penis into your bladder. This helps protect the tube where urine passes (urethra) from the bladder out of the body from possible damage.

You might need to have another treatment of HIFU or cryotherapy if a scan or tissue samples shows there still might be cancer in your prostate. Your doctor will talk to you about this. 

Quality of life questionnaire
You fill in a questionnaire:

• before starting treatment
• during treatment 
• for up to 5 years after treatment

The questions ask about:

• any side effects 
• your daily activities
• general heath

You can choose to fill the questionnaire in:

• when you see your doctor 
• by telephone – a member of the research team will call you
• by email – to a secure NHS account

Extra samples for research
You give extra blood and urine samples before and during treatment. 

You have prostate tissue samples (biopsies) taken as a part of your routine care. Your doctor takes these when you are diagnosed and at times during your treatment. The research team want a small piece of these biopsies. 

Researchers want to use these samples to help improve the diagnosis and the treatment of prostate cancer. 

Imaging scan information
As a part of the trial you have scans of your prostate to see how treatment is working. The research team want to store these scans and use them to see if there is a better way to identify prostate cancer. 

You don’t have to agree to this. You can still take part in the trial. 

Health information
The team want to know what happens to your health after the trial has finished. They do this by looking at your health records held by the NHS. 

You don’t have to agree to this. You can still take part in the trial.