At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- bpMRI (diagnostic test), Image-Fusion targeted and systematic Biopsy (diagnostic test)
- How long the study runs
- Study runs about 38 months (dates as stated)
- About the drug or intervention
- bpMRI — diagnostic test: biparametric MRI takes 30-40 minutes and requires a contrast injection called gadolinium (like a dye). · Image-Fusion targeted and systematic Biopsy — diagnostic test: During image fusion targeted biopsy, the biopsy operator uses the MRI scans that were taken beforehand but laid on top of the live ultrasound images during the biopsy.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Male
- Number of participants
- 3,600
- Started
- 2022-11-02
- Last checked
- 2025-07
Plain English Summary
What is this study?
- • Testing a new treatment for prostate cancer
- • NA - 3,600 participants
- • To evaluate the role of biparametric MRI and image-fusion targeted biopsies for the detection of prostate cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with prostate cancer
- • Male only
Where?
- • Southend-on-Sea - Southend University Hospital
- • Southampton - University Hospital Southampton
- • Gillingham - Medway Maritime Hospital
- • Basingstoke - Basingstoke Hospital
- • +11 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
To evaluate the role of biparametric MRI and image-fusion targeted biopsies for the detection of prostate cancer. To determine whether biparametric MRI (bpMRI) could be recommended as an alternative to multiparametric MRI (mpMRI) for the detection of clinically significant prostate cancers in patients at risk. To determine whether image-fusion targeted biopsy is better than visual-registration (cognitive) targeted biopsy at detecting clinically significant prostate cancers in patients requiring prostate biopsy due to a suspicious MRI.
More detail
Background and study aims: The aim of this study is to improve the way prostate cancer is diagnosed by looking at two different types of MRI scans and two different types of prostate biopsy (tissue samples). A large study such as this is required to help the NHS decide how to diagnose prostate cancer in the future. If a person is suspected of having prostate cancer, then they are referred by their GP. At the hospital clinic, the participant will then have an MRI scan. If this scan shows that cancer might be present, then the doctor will usually suggest that the patient has a biopsy. There are two ways of doing a prostate MRI. One takes 30-40 minutes and requires a contrast injection called gadolinium (like a dye). This is called long MRI and is most commonly used in the NHS. Gadolinium is safe as it rarely causes any bad reaction but using it means that the scan takes more time. Another type of MRI takes 15-20 minutes and does not use gadolinium contrast. This is called a short MRI. Many studies over the last 5 years have shown that the long and short MRIs are similar in their accuracy in diagnosing important prostate cancer. These studies have not been of high quality or large enough to change NHS practice. Patients with suspicious areas on the MRI are usually advised to have a prostate biopsy. This involves taking tissue samples using a needle. The samples are then looked at under the microscope by a pathologist to see if cancer cells are present. There are two ways of doing a prostate biopsy. One is where the person doing the biopsy decides where to put the biopsy needle by looking at the MRI scans that have been already taken on a computer screen. The needle is guided to the prostate using live ultrasound scans that are shown on a different screen near the patient. The biopsy operator makes a judgement about where to place the biopsy needles. This is called visual registration. Tissue samples from other areas of the prostate that look normal on the MRI scans are also taken to ensure cancer is not missed. The other type of biopsy is called image fusion. During image fusion biopsy, the biopsy operator uses the MRI scans that have been taken beforehand but laid on top of the live ultrasound images during the biopsy. This uses software and takes a few minutes longer to perform. Once the MRI images and ultrasound images are 'fused', the actual biopsies are taken as normal. Studies over the last 5 years have shown mixed results. Some have shown that image fusion biopsy is no better than visual registration biopsy, whilst a few have shown it might make a difference in improving cancer detection. As a result, it is not known for certain which way is better. A large study is needed to show whether the investigators need to do image fusion or not, in order for the NHS to decide whether or not to use it in all hospitals doing prostate biopsies.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Male only
Biomarkers mentioned
What the study is looking for
- ✓Age 18 years or above (no upper limit)
- ✓Patients with a prostate (either cis-male gender or trans-female gender with no prior androgen deprivation hormone...
Who cannot take part
- ✗PSA \>50ng/ml
- ✗Prior prostate MRI or prostate biopsy in the two years prior to screening visit
- ✗Prior diagnosis of prostate cancer
- ✗safety concern to MRI or gadolinium contrast
- ✗Previous hip replacement to both hips
See the full criteria
Where Is This Study? (15 UK sites)
Southend University Hospital
Southend-on-Sea SS0 0RY, United Kingdom
University Hospital Southampton
Southampton SO16 6YD, United Kingdom
Medway Maritime Hospital
Gillingham ME7 5NY, United Kingdom
Basingstoke Hospital
Basingstoke RG24 9NA, United Kingdom
Southmead Hospital
Bristol BS10 5NB, United Kingdom
Addenbrooke Hospital, Cambridge
Cambridge, United Kingdom
Cumberland Infirmary
Carlisle CA2 7HY, United Kingdom
St Peters Hospital
Chertsey, United Kingdom
Darent valley Hospital
Dartford DA2 8DA, United Kingdom
Northwick Park Hospital
Harrow, United Kingdom
St James's Hospital, Leeds
Leeds, United Kingdom
Charing Cross Hospial
London W6 8RF, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
Northampton General Hospital
Northampton, United Kingdom
Hillingdon Hospital
Uxbridge UB8 3NN, United Kingdom
How to Get in Touch
Hashim Ahmed
Sponsor contactCONTACT
Thiagarajah Sasikaran
Sponsor contactCONTACT
