A study investigating a new way to look at the prostate gland when taking samples to diagnose cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This study is looking at using a new technique called SmartTarget when taking tissue samples to diagnose prostate cancer. The study is for men who are due to have a targeted prostate biopsy.
More about this trial
You will have a number of tests if your doctor thinks you have prostate cancer including an ultrasound scan. You have this scan through the back passage (rectum). It is a transrectal ultrasound scan (TRUS). It looks for abnormal areas in the prostate gland.
If there are abnormal areas on the scan your doctor will want to take a small sample of tissue (a biopsy). You have the biopsy taken through the rectum. This is called a TRUS biopsy.
Sometimes the results of the TRUS biopsy are not clear and you need to have an MRI scan and further biopsies.
There are different types of biopsy. One type is a targeted prostate biopsy. With this type of biopsy your doctor uses an ultrasound scan as well as information from the MRI scan to help them find the abnormal areas and take biopsies of the prostate gland.
But the doctor has to check 2 screens, one with the MRI information and the other with the ultrasound scan images. They have to judge where to take the tissue samples.
In this study, the researchers are looking to see if they can improve the targeted prostate biopsy. They have developed a new medical device called SmartTarget.
This creates a 3D model of the prostate from the MRI scan. They then combine this model with the ultrasound scan images that the doctor uses during the biopsy. This means the doctor can see areas that might have cancer on the one screen making it easier to find and take the samples.
The researchers hope this will mean that they need to take fewer biopsies and so reduce the side effects men can have.
The aim of this study is to see whether using the SmartTarget is better than a standard targeted prostate biopsy.
Who can enter
The following bullet points list the entry conditions for this study. If you are unsure about any of these speak with your doctor or the study team. They will be able to advise you.
You may be able to join this study if all of the following apply. You
- Have had a transrectal ultrasound guided (TRUS) biopsy but need to have a repeat biopsy done
- Have had an MRI scan that shows an area, or areas, that might be cancer
You cannot join this study if any of these apply. You
- Have had hormone therapy in the last 6 months apart from having the drugs finsteride or dutasteride
- Have a condition which means you are likely to bleed
- Are not able to have transrectal ultrasound
- Have had radiotherapy to the area between your hip bones (pelvis)
- Have had high intensity focused ultrasound (HIFU), cryosurgery, thermal therapy, irreversible electroporation, photodynamic therapy, photothermal therapy or microwave therapy to your prostate
- Have any signs that the cancer has spread out side of the prostate gland
Trial design
Researchers need about 150 men to take part in this study. Everyone will have a targeted prostate biopsy. In total you will have 6 samples taken during the biopsy
- 3 using the SmartTarget
- 3 using the standard way of doing a targeted biopsy
You have the biopsy done using local anaesthetic. This means your doctor will numb the area. You can have sedation (medicine to make you relax) if you would like.
There will be 2 doctors doing the procedure. 1 will take samples using the SmartTarget and 1 will take samples the standard way.
The 2 doctors will not be present for both biopsies. This means the researchers can more easily compare which type of biopsy is better.
The whole procedure will take about 30 minutes.
The trial team will ask you to complete some questionnaires before you have the biopsy and about 6 weeks afterwards. These will include questions about
- What it is like for you to pass urine
- Whether you are able to get an erection
- Your general health.
You can complete these questionnaires at home or in the clinic. They will take around 15 minutes to complete.
Hospital visits
You have 3 visits to the hospital if you take part in this trial.
The first visit gives you the chance to talk about the trial and what is involved.
You may have some blood tests at this visit. This will include a check of your 
if you have not had this test in the last 3 months. The team will also ask you to complete the questionnaires.
At the second visit to hospital you have the targeted prostate biopsy. After the biopsy you need to pass urine before you can go home.
About 6 weeks after the biopsy you go to the hospital for a 3rd visit.
The doctors will ask about any side effects or problems you have had after the biopsy. They will also ask you to complete the questionnaires.
Some men may be given the option of having this follow up as a telephone consultation.
Side effects
The most common side effects after a targeted 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
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.
Chief Investigator
Professor Mark Emberton
Mr Hashim Ahmed
Supported by
University College London Hospitals NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
