A study looking at MRI scans and targeted treatment for men with prostate cancer (FORECAST)

Cancer type:

Prostate cancer

Status:

Open

Phase:

Other

This study is looking at MRI scans and targeted treatment for prostate cancer that has come back after radiotherapy.

More about this trial

Many men with prostate cancer have radiotherapy. But in some men the cancer comes back (recurs). Doctors use different tests to find out where the cancer has come back. These include an MRI scan, bone scan, and a PET-CT scan using a radioactive drug (a tracer). The study team want to see if an MRI scan of your whole body can replace these other tests.

If the scan shows that your prostate cancer has come back only inside your prostate gland, you usually have samples taken (biopsies) to confirm that it is cancer. The study team want to see if taking biopsies using a high definition MRI scan is as good at showing where the cancer is in the prostate as the standard way of taking biopsies. This type of scan is called a multi parametric (mp) MRI scan.

If cancer comes back in the prostate gland, you have more treatment. You may have surgery, more radiotherapy, or treatment that kill cancer cells by either heating (high intensity focused ultrasound or HIFU) or freezing (cryotherapy). But these treatments can have significant side effects. The study team wants to see if they can safely treat just the area of cancer with HIFU or cryotherapy, rather than the whole prostate gland and so reduce side effects.

The study team also want to see if using HIFU and cryotherapy to treat the cancer in the prostate gland will be helpful for men whose cancer has come back elsewhere in the body (metastatic prostate cancer).

The team also want to use 3 new types of blood tests to help know more about your prostate cancer. These blood tests are:

  • leukocyte coping capacity (LCC)
  • cell free DNA (cfDNA)
  • circulating tumour cells (CTC)

The aims of this study are to see

  • If a whole body MRI scan is better at showing where cancer has come back
  • If taking biopsies only from areas of the prostate gland that look cancerous, using a multi parametric (mp) MRI scan, is as useful as taking biopsies from the whole prostate gland
  • What side effects men may have following HIFU or cryotherapy
  • If men are willing to have treatment with HIFU or cryotherapy when their cancer has come back

Who can enter

You may be able to enter this study if

You cannot enter this study if

  • You have had hormone therapy in the last 6 months (except tablets called finasteride or dutasteride)
  • You have already had high intensity focused ultrasound (HIFU) or cryotherapy
  • You have had any other type of treatment directly into your prostate gland for prostate cancer such as treatment using an electrical current (Nanoknife)
  • Your PSA blood test result is 20ng/ml or higher
  • Your PSA blood test result is doubling every 3 months or less
  • You are unable to have an MRI scan
  • You have a metal implant such as a pacemaker, surgical clips, pins or plates and cochlear implants (for deafness) - these can affect the quality of the MRI scan
  • You are unable to have general anaesthetic Open a glossary item or anaesthetic into your spine

Trial design

All men taking part in this study will have the following scans

  • PET-CT scan using a choline radioactive tracer
  • MRI scan of your whole body
  • Multiparametric (mp) MRI scan of your prostate and the area between your hip bones (your pelvis)
  • Bone scan (unless you have had one in the last 6 months)

If you are suitable for treatment just to your prostate gland, the study team need to see exactly where the cancer is. They will do this by taking samples (biopsies) of your whole prostate and targeted biopsies of any areas that look like they could be cancerous following an mp MRI scan.

The study team will look at your biopsy results to see if you can have treatment targeted to the areas of cancer (focal salvage treatment). If this type of treatment is not suitable for you, the trial team will talk to you about your treatment choices.

If targeted treatment is suitable for you, the trial team will use either high intensity focused ultrasound (HIFU) or cryotherapy to treat the cancer. The type of treatment they use will depend on the location and size of the cancer in your prostate gland.

The doctors will look at the results of the ultrasound scans and biopsies everyone has and compare them with the results of the mp MRI scans. From these results they hope to see if it will be possible in future to use the mp MRI scan to take samples just from the areas of the prostate gland that look cancerous.

After treatment, the trial team will ask you to complete some questionnaires which they will post to you. The questions will ask about whether the treatment has caused side effects, for example, if you have bladder and bowel problems, and if your sex life has been affected.

Blood samples

As part of this study the team want to look at 3 new blood tests

  • leukocyte coping capacity (LCC)
  • cell free DNA (cfDNA)
  • circulating tumour cells (CTC)

The LCC tests for the level of white blood cells. White blood cells help fight infection. They may become low in times of stress and so you may be more prone to infections. The study team want to see what effect your cancer and treatment is having on your immune system.

The cfDNA and CTC tests are new tests looking for cancer cells in the blood. The study team want to compare the level of the blood tests to the scans and biopsies that you have as part of the study. They would like to see if it possible to reduce the number of other tests people usually have by using these new blood tests.

You have the blood tests using blood taken from a vein in your arm. The LCC test can be done as a finger pin prick if you prefer. 

It is up to you whether you want to have 1, 2, all or none of these tests. You can still take part in this study.

If you have targeted treatment (either HIFU or cryotherapy) or any other treatment as part of this study the team would like to take some extra blood to use for these tests. Again it is up to you if you want to have these blood tests. 

 

Hospital visits

You see the doctor to have some tests before taking part. These tests include

You will also be asked if you are willing to have the LCC, cfDNA and CTC blood tests.

You also have a

  • PET-CT scan using a choline radioactive tracer
  • MRI scan of your whole body
  • Multiparametric (mp) MRI scan of your prostate and pelvis
  • Bone scan (unless you have had one in the last 6 months)

In total you may have up to 5 hospital visits as part of this trial. The number of visits will depend on whether the trial team think you are suitable for treatment or not. Treatment will be either cryotherapy or high intensity focused ultrasound. You have this treatment as an outpatient. You will have a catheter in place for between 5 and 21 days and one of the visits to hospital will be to remove the catheter.

After treatment, the study team will see how you are getting on either by phone, or at hospital visits if you prefer. They will contact you 4 weeks and 12 weeks after you finish treatment, then every 3 months until a year after you finish treatment. Your doctors will ask how you are and whether you have any side effects from your treatment. At these times you also will have a blood test either at your local hospital, GP surgery, or with the study team. 12 months after you have finished treatment you will also have more scans these may include multiparametric MRI scan, a bone scan and a PET CT scan using a choline radioactive tracer.

Side effects

The side effects of a prostate biopsy can include

  • Blood in your urine
  • Blood in your semen
  • Bleeding from your back passage (rectum)
  • Bruising of the area between your penis and back passage (the perineum)
  • Pain or discomfort in your bottom (anal area) this should be temporary
  • Infection (this is rare)

Side effects of high intensity focused ultrasound (HIFU) and cryotherapy can include

  • Difficulty getting or keeping an erection
  • Pain or difficulty passing urine because of dead prostate tissue passing out through the tube that carries urine (the urethra)
  • A hole (fistula) between the back passage (rectum) and the tube that carries urine (urethra)

Side effects of cryotherapy can also include

  • Pain where the cryotherapy needles were put in, and also around your back passage (rectum)
  • Bleeding where the cryotherapy needles were put in
  • Urine infection
  • Bruising or swelling of your scrotum
  • Tingling or numbness around your penis
  • Leaking urine

Side effects of HIFU can also include

  • Not being able to control passing urine (urinary incontinence)
  • Narrowing of the neck of the bladder
  • Inability to pass urine (retention) due to a narrowing of the tube that carries urine (urethral stricture)

We have detailed information about the following scans that includes the possible side effects of these tests

Location

Basingstoke
Brighton
Kings Lynn
London
Southampton

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

Mr Hashim Ahmed

Supported by

University College London Hospitals NHS Foundation Trust

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11704

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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