A study looking at a new way to take tissue samples from the prostate (CamPROBE)

Cancer type:

Prostate cancer

Status:

Open

Phase:

Other
This study is for people who are going to have a sample of tissue taken from their prostate (biopsy) to:
  • help diagnose prostate cancer
  • monitor prostate cancer
It is looking at a new way of taking prostate biopsies called Cambridge Prostate Biopsy Device (CamPROBE).

More about this trial

To diagnose or monitor prostate cancer, your doctor takes samples of tissue from the prostate to look for cancer cells. You usually have a type of biopsy called transrectal ultrasound guided (TRUS) biopsy. 
 
To have a TRUS biopsy, your doctor puts an ultrasound probe into your back passage. They then gently push a small needle along the ultrasound probe and into the prostate gland through the bowel or the back passage (rectum) wall. 
 
But TRUS biopsies can have some problems. Sometimes it can:
  • cause infections that can be severe (sepsis)
  • miss the cancer, especially if it’s in the front of the prostate
Doctors created a new device to take prostate biopsies called CamPROBE. 
 
They take tissue samples by putting 2 small tubes (needle guides) through the skin between the anus Open a glossary item and scrotum (the perineum Open a glossary item). They then pass the biopsy needles through these needle guides to get to the prostate.
 
Doctors think that the CamPROBE method might be better and safer than TRUS biopsies. This is because the biopsy needles no longer go through the back passage or bowel wall. 
 
The main aims of this study are to find out:
  • how safe the CamPROBE method is at taking tissue samples
  • how people feel about having a biopsy using CamPROBE

Who can enter

The following bullet points list the entry conditions for this study. 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 study if all of the following apply. You:
  • are going to have a prostate biopsy to help diagnose or monitor prostate cancer
  • are aged 18 or over 
Who can’t take part
You cannot join this study if any of these apply. You:
  • can’t have a prostate biopsy for any reason, for example you have a condition which means you are likely to bleed 
  • have had surgery to your anus Open a glossary item or the area between the anus and the scrotum (the perineum) 
  • can’t lie down with your legs raised and apart for 45 minutes 
  • are taking part in another clinical trial looking at a new drug or device 

Trial design

Researchers hope that around 40 people from the UK will agree to take part. 
 
Before having the CamPROBE biopsy, you have:
  • a drug to prevent infections (an antibiotic)
  • a drug to empty your back passage of poo (a suppository) 
You then put on a hospital gown and lie down on a special bed with your legs raised and resting on supports. 
 
Your doctor gives you a medicine to numb 2 small areas between the anus and scrotum (perineum). After a few minutes, they put an ultrasound probe into the back passage (rectum) and place the CamPROBE needle guide into the perineum.
 
The doctor then uses the images from the ultrasound probe to guide the CamPROBE needle guide into the prostate gland. They then take the prostate biopsies.

 

After taking the biopsies, your doctor removes the needles and the ultrasound probe.
 
You stay in hospital until you have passed urine, but you shouldn’t need to stay overnight. The study team will give you antibiotics to take at home. 
 
Questionnaires
You complete questionnaires:
  • when you finish the CamPROBE biopsy
  • after 7 days 
  • after 30 days (a month)
The questionnaires ask about whether you have had any side effects from the biopsy.
 
You can complete the day 7 and day 30 questionnaire at home or over the phone. 

Hospital visits

You have the CamPROBE biopsy when you are at the hospital having a routine visit. So you do not have any extra hospital visits. 
 
You will be at the hospital for about 2 hours. 
 
After the biopsy, you speak with the trial team:
  • the following day (day 2)
  • after 1 week
  • after a month
They check how you are and whether you have had any side effects.
 
Ask your doctor or research nurse when they think the biopsy results will be available. Usually, the amount of time it takes to receive the CamPROBE biopsy results is the same as if you had a TRUS biopsy. 

Side effects

The study team will monitor you during the biopsy. You have a phone number to call them afterwards if you are worried about anything. 
 
Doctors think that the most common side effects of having a CamPROBE biopsy are:
  • blood in the urine and semen Open a glossary item
  • bruising in the skin around the rectum and scrotum 
  • discomfort (pain) in the area of the biopsy 
The study team will tell you about what to look out for and when you should contact a doctor before you go home. 

Location

Cambridge
Cheltenham
Huntingdon
Peterborough

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 Vincent J Gnanapragasam

Supported by

Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
National Institute for Health Research (NIHR)
JEB Technologies Lt

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16081

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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