A study using ultrasound scans to diagnose prostate cancer (CADMUS)

Cancer type:

Prostate cancer

Status:

Open

Phase:

Other

MRI scans are currently used at some hospitals to help diagnose prostate cancer. In this study doctors want to see if an ultrasound scan using a special dye is just as good. 

More about this trial

You have an MRI scan to identify areas in your prostate that might be cancer. To confirm this doctors use a targeted biopsy to take samples of tissue (biopsy Open a glossary item) from the areas. 

Ultrasound scans are less expensive and take less time to do than MRI scans. Researchers think doing an ultrasound using a contrast dye Open a glossary item might be just as good at showing areas in the prostate that could be cancer.

In this study you have 

  • an MRI scan
  • an ultrasound scan
  • a biopsy (if your doctor needs it)

The study team will compare the MRI scan with the ultrasound scan and the results of the biopsy.

The aim is to see if the ultrasound scan is as good as the MRI scan to diagnose prostate cancer.

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 

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

  • Have a raised PSA blood test result or another clinical sign that means you might need to have a biopsy of your prostate done 
  • Have a PSA blood test result of 20ng/ml or less in the past 6 months
  • Must be able to have transrectal ultrasound
  • Are able to have a general anaesthetic Open a glossary item

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

  • Have prostate cancer that has spread to the lymph glands Open a glossary item or to another part of the body 
  • Your prostate gland is more than 60cc in volume or is found to be more than this when the ultrasound is done for this study 
  • Have had hormone therapy in the past 6 months 
  • Have already had treatment to the prostate such as radiotherapy, HIFU, cryosurgery
  • Have had surgery or vaporization (laser therapy) Open a glossary item to the prostate for benign prostatic hyperplasia Open a glossary item (an enlarged prostate) in the past 6 months  
  • Have a medical condition that means you can’t have the contrast dye used for the ultrasound
  • Have any other medical condition that the study team think could affect you taking part

Trial design

Researchers need up to 500 men to join this study. All men joining the study have an MRI scan and ultrasound scan of their prostate. 

The ultrasound uses a probe similar to the usual prostate scans but there are no needles used and no samples of tissue (biopsies) are taken at this time.
 
The only other difference is that you have a contrast dye Open a glossary item. You have this as an injection into a vein. The dye shows the blood supply to the prostate. It also shows areas of the prostate that might be cancer. 

Areas of prostate cancer are usually harder than the surrounding tissue. So the doctor will also use elastography. This shows how soft or hard the tissue is.

You have the MRI scan on another day. You have a contrast dye injected into a vein. This is a different dye to the one used in the ultrasound. It shows the blood vessels of the prostate and any areas that might be cancer.  

You will only be told if you need to have a biopsy. You won’t be told which scan showed an area of concern in your prostate. This is called a blinded study Open a glossary item

The doctor doing the biopsy will take the prostate samples in a certain order. A computer will set out the order at random Open a glossary item.  

Having the biopsy
When you have the targeted biopsy you have an injection of local anaesthetic Open a glossary item to numb the area. This is to make the procedure as painless as possible. You can also choose to have some medication to reduce anxiety and make you sleepy (a sedative Open a glossary item). 

When taking the biopsy the doctor looks at the scan. They also look at your prostate using an ultrasound scanner to see live images of the prostate. This helps the doctor to take the biopsies more accurately. 

At the end of the study, if you want to know, your doctor can tell you the results of the ultrasound scan and MRI scan. 

Quality of life
The study team will ask you to fill out a questionnaire 

  • when you agree to take part in the study
  • when you have your MRI scan
  • when you have your biopsy
  • 6 weeks after your biopsy

The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study

Hospital visits

You have the ultrasound scan on the same day you agree to take part in the study. You might also have blood tests done. 

You have a type of MRI scan called a multiparametric MRI scan (mpMRI scan) done if you haven’t had one done in the past 6 months. Or if you have only had a standard MRI scan done. 

You have the biopsy done as a day case in hospital. After the biopsy you stay at the hospital until you have passed urine and the medication has worn off. 

As part of the study you have another appointment about 6 weeks after the biopsy. Or a member of the study team can phone instead if you prefer.

Side effects

The most common side effects after a prostate biopsy are

  • blood in the urine
  • blood in the semen
  • bleeding from the back passage (rectum), this is more likely if you have haemorrhoids
  • bruising in the area where the biopsy needle is inserted (the perineum)
  • pain and discomfort in the anal area, this is temporary

The contrast dyes used for the ultrasound and MRI scan are safe. You aren’t likely to have any side effects. A few people have reported 

  • feeling dizzy
  • feeling sick
  • skin rash
  • pain in the head or back

Your doctor will talk to you about the possible side effects of the biopsy and contrast dyes before you agree to take part. 

Location

London

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

Hashim Uddin Ahmed

Supported by

Bracco S.p.A
NIHR Clinical Research Network: Cancer
Prostate Cancer UK 
Moulton Charitable Foundation
University College London (UCL)
Hitachi Medical Systems UK Ltd
BK ultrasound systems
GE Healthcare
Esoate

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13797

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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