A trial comparing different treatments for prostate cancer that has spread (IP2 ALANTA)

Cancer type:

Prostate cancer
Secondary cancers

Status:

Open

Phase:

Phase 2

This trial is looking at treating the prostate gland as well as areas of cancer that has spread well beyond the prostate.

More about this trial

Advanced prostate cancer is when the cancer has spread from the prostate to another part of the body (metastatic prostate cancer). The standard treatment Open a glossary item for advanced prostate cancer is hormone therapy
 
Hormone therapy treats the cancer wherever it is in the body. Recent research suggests that also treating the cancer inside the prostate itself might be useful for men with advanced prostate cancer. 
 
Researchers are doing this trial to find out more about this. They want to compare the standard treatment of hormone therapy with treatments that treat cancer inside the prostate.
 
In this trial everyone has the choice of hormone therapy with or without chemotherapy. Some men will be given the choice  of surgery or radiotherapy,  and some have treatments that heat (HIFU Open a glossary item) or freeze (cryotherapy Open a glossary item) the prostate. These treatments are similar to what would be offered to men with cancer that hasn’t spread beyond the prostate gland.

Also in this trial men who are randomised Open a glossary item to have the additional treatments will also have the choice of specialised radiotherapy that targets cancer anywhere in the body. This is stereotactic radiotherapy Open a glossary item.

 
Before doing a large trial researchers need to know if men are willing to take part in a trial like this. This is called a pilot study. This summary is about the pilot study.
 
The aim of this pilot study is to find out:
  • how willing men are to take part 
  • more about the side effects 
  • how well the treatments work

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. 
 
Who can take part
 
You may be able to join this trial if all of the following apply. 
You:
  • have cancer inside the prostate (you have had a sample of tissue taken (biopsy Open a glossary item) to confirm this)
  • were diagnosed with prostate cancer within 6 months of having tests for this trial
  • have cancer that has spread to another part of the body (metastatic)
  • are fit enough to have the standard treatment for prostate cancer and to have the other treatments used in this trial
  • are up and about for at least  half the day and can look after yourself (performance status 0, 1 or 2)
  • have had or are able to have tests to diagnose that your cancer has spread 
Who can’t take part
 
You cannot join this trial if any of these apply. 
You:
  • have had long term anti androgen treatment Open a glossary item such as flutamide or enzalutamide 
  • have had hormone treatment for your prostate cancer unless you started it within the last 3 months 
  • have had another treatment (for example  chemotherapy) for prostate cancer 

Trial design

This is a phase 2 trial. There are 2 stages in this trial. At the moment only the first stage is open for men to join. The first stage is a pilot study
 
The trial team need 80 men to take part in this stage. You are put into 1 of 3 treatment groups. 
 
It is a randomised trial. Neither you nor your doctor can choose which group you are in. The 3 groups are:
  • standard treatment 
  • standard treatment followed by radical treatment (surgery or radiotherapy)
  • standard treatment followed by minimally invasive ablation

Standard treatment
The NHS gold standard treatment Open a glossary item is hormone therapy. You have it as one or both of the following:

  • a tablet
  • an injection 
How often you have it depends on the type of hormone therapy. 
 
You might also have chemotherapy or low dose radiotherapy. Your doctor will talk about this with you.
 
Radical treatment
You can have up to 6 months of hormone therapy before having surgery. Between 6 and 9 months after starting the hormone therapy you have an MRI scan Open a glossary item of the prostate. The team also take tissues samples (biopsies) of your prostate. This is to see if there are any cancer cells present. 
 
If there are no cancer cells you continue to have hormone therapy. You may not need to have radical treatment. You continue to have appointments with your doctor. 
 
If there are cancer cells in your biopsies, you then have radical treatment. Radical treatment treats the whole prostate. Your doctor will decide which treatment you have. And they will explain this to you in more detail. You have one of the following:
  • surgery
  • radiotherapy
Surgery to remove the prostate is a prostatectomy. The surgeon removes the whole prostate. You have open surgery or keyhole surgery Open a glossary item. Your doctor will talk to you about what type of surgery might be best for you. 
 
You have external radiotherapy to the prostate. Before starting treatment, the radiotherapy team need to plan where to give the radiotherapy. This involves going to the hospital for a planning appointment
 
You have radiotherapy every day from Monday to Friday with a break at weekends. Each treatment takes about 10 minutes. You have it for 4 to 6 weeks. 
 
You might also have stereotactic radiotherapy to the areas of your body where the cancer has spread. 
 
Minimally invasive ablation
You have up to 6 months of hormone therapy before having minimally invasive ablation. Between 6 and 9 months after starting the hormone therapy you have an MRI scan of your prostate. The team also take tissues samples (biopsies) of the prostate. This is to see if there are any cancer cells present. 
 
If there are no cancer cells present, you continue to have hormone therapy.  You may not need to have minimally invasive ablation. You continue to have appointments with your doctor.
 
If there are cancer cells in your biopsies, you then have minimally invasive ablation. Your doctor will decide which treatment you have. You have one of the following:
HIFU uses sound waves to heat the cancer cells in the prostate. The heat destroys the cancer cells. You have an ultrasound probe put into your back passage (rectum). The doctor uses the probe to target the cancer cells and to make the sound waves that heat and kill the cancer cells. 
 
Cryotherapy uses extreme cold to destroy the cancer cells. You have an ultrasound probe put into your back passage. The doctor uses the probe to see where the cancer cells are in the prostate. Special cryotherapy needles are placed through the skin of the perineum (the area of skin behind the testicles). These needles are hollow. A gas is passed through the needles which freezes and kills the cancer cells. 
 
HIFU and cryotherapy are done as a day case, so you shouldn’t need to stay overnight. You have a general anaesthetic Open a glossary item so you don’t feel anything. Both treatments take about 3 hours. 
 
You might also have stereotactic radiotherapy to the areas of your body where the cancer has spread. 
 
PSMA PET scan
This is a new type of whole body scan. The team want to find out if it is more accurate than the current ways of detecting prostate cancer. As part of this trial, the team would like you to have this scan on two separate occasions. You don’t have to agree to have this scan. You can still take part in the trial.  
 
Samples for research
The trial team will ask you to give extra blood and urine samples. You don’t have to agree to give these samples. You can still take part in the main trial.
 
Quality of life
When you agree to take part and at regular times during the trial you fill in a few questionnaires. The questions ask about:
  • your general health
  • how your bowels are working
  • how well you are passing urine
  • your sex life
You continue to fill in these questionnaires at set times for up to 4 years after you were put into your treatment group. You can have them posted or emailed to you. This is called a quality of life study.

Hospital visits

You see the doctor to have tests when you agree to take part. These tests might include:
  • a physical examination
  • blood tests
  • urine test
  • PSMA PET scan 
  • MRI scan
During the trial you see the doctor at:
  • week 12
  • week 26
  • week 28
  • week 32 
  • week 34
This is to see how you are and for blood tests. You have another PSMA PET scan after finishing treatment.
 
You see the doctor as part of the trial: 
  • every 12 weeks for a year 
  • and then every 24 weeks from year 2 to year 4 

Side effects

Your doctor and nurse will monitor you closely for any side effects. Let your doctor or nurse know as soon as possible if:
  • you have severe side effects 
  • your side effects aren’t getting any better
  • your side effects are getting worse
Hormone therapy 
The side effects of hormone therapy can include:
  • tiredness
  • weight gain
  • swelling of the breast 
  • tenderness of the breast
Surgery
The side effects of surgery can include:
  • not being able to get an erection (erectile dysfunction)
  • leakage of urine or not been able to control when you pass urine (urinary incontinence) 
Radiotherapy
The side effects of radiotherapy can include:
  • not being able to get an erection (erectile dysfunction)
  • leakage of urine or not been able to control when you pass urine (urinary incontinence) 
  • bleeding from the back passage (rectum)
  • diarrhoea
  • discomfort in the back passage
Minimally invasive ablation (HFU and cryotherapy) 
The side effects of minimally invasive ablation can include:
  • not being able to get an erection (erectile dysfunction)
  • leakage of urine or not been able to control when you pass urine (urinary incontinence) 
We have information about:
You doctor or a member of the trial team will talk to you about the possible side effects of all the treatments used in the trial before you agree to take part.

Location

Bath
Camberley
Coventry
Exeter
Kings Lynn
London
Newcastle upon Tyne
Norwich
Slough
Southampton
Sunderland
Wirral
Worcester
Wrexham

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

Professor Hashim U Ahmed
Dr Martin J Connor 

 

Supported by

Wellcome Trust
NIHR Imperial Biomedical Research Centre
Imperial Clinical Trial Unit (ICTU)
Imperial College Healthcare NHS Trust
Imperial Prostate, Imperial College London
Radiotherapy Trials Quality Assurance (RTTQA

 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16022

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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