
"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing treatment to the whole prostate with treatment to only the areas of cancer in the prostate.
There are 2 parts to the CHRONOS trial. This is the summary of CHRONOS A. You can read about the 2nd part CHRONOS B.
When there is a lot of cancer in the prostate doctors treat the whole prostate. This can be either by:
This called radical therapy. This controls the cancer but there are side effects.
There are treatments that target only the areas of cancer in the prostate. These are:
This is called focal therapy. Some research shows that focal therapies might control the cancer as well as radical therapies. And that the side effects aren’t as bad.
But there hasn’t been any research that compares how well radical therapies and focal therapies control prostate cancer. And the differences in the quality of life of the men having these treatments. This is what the researchers want to do in this trial.
The aims of CHRONOS A are to find out:
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.
Who can take part
You may be able to join this trial if all of the following apply. You:
Who can’t take part
You cannot join this trial if you have already had treatment for prostate cancer.
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
You have 1 of the following treatments:
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 or a
.
Prostatectomy is surgery to remove all your prostate gland. This might include removing the surrounding . 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 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 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:
The questions ask about:
You can choose to fill the questionnaire in:
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.
You see the doctor for some tests before taking part. These tests include:
You see the doctor after treatment at:
You have the same tests as before.
People in the focal therapy group have an MRI scan at 1 year.
Please note
If the pilot study (stage 1) is not successful then the larger trial won’t go ahead. In this case people in the pilot study are followed up by the team for at least 3 months. After this you have routine follow up which your doctor will tell you how often that is.
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.
Side effects from external radiotherapy, prostatectomy and brachytherapy can include:
We have information about the side effects of:
We have information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Hashim Ahmed
Imperial College London
Prostate Cancer UK
Imperial Clinical Trials Unit (ICTU)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”