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Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer

Sponsor: Imperial College London

NCT ID: NCT05574647

View on ClinicalTrials.gov ↗

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.

Prostate CancerAdenocarcinomaProstatic NeoplasmsProstatic DiseasesNeoplasms

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What we know so far

Condition· Matched your search
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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

PSA

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
Randomisation 1 Inclusion Criteria: * 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 use at all). * Referred to hospital and advised to undergo a prostate MRI because of an abnormal digital rectal examination (regardless of PSA level) and/or an elevated PSA (within 6 months of screening visit) PSA \>/=3.0ng/ml for age 50-69 years PSA \>/=5.0ng/ml for age \>/=70 years If family or ethnic risk for prostate cancer, PSA \>/=2.5ng/ml for age 45-49 years Exclusion Criteria: * PSA \>50ng/ml * Prior prostate MRI or prostate biopsy in the two years prior to screening visit * Prior diagnosis of prostate cancer * Contraindication to MRI or gadolinium contrast * Previous hip replacement to both hips * Contraindication to performing a biopsy guided by a transrectal ultrasound probe Randomisation 2 Inclusion Criteria: * Visible suspicious finding on mpMRI or bpMRI from randomisation 1 requiring a targeted biopsy (MRI score 3, 4, 5 on either Likert or PIRADS schema) Exclusion Criteria: * As above for randomisation 1 * Patient refusal for biopsy

Where Is This Study? (15 UK sites)

Southend University Hospital

Southend-on-Sea SS0 0RY, United Kingdom

Recruiting
Site contact (verified)
Peter ArcherPrincipal Investigator

University Hospital Southampton

Southampton SO16 6YD, United Kingdom

Recruiting
Site contact (verified)
Chedgy EdmundPrincipal Investigator

Medway Maritime Hospital

Gillingham ME7 5NY, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Shikohe MasoodPrincipal Investigator

Basingstoke Hospital

Basingstoke RG24 9NA, United Kingdom

Recruiting
Site contact (verified)
Richard HindleyPrincipal Investigator

Southmead Hospital

Bristol BS10 5NB, United Kingdom

Recruiting
Site contact (verified)
Jonathan AningPrincipal Investigator

Addenbrooke Hospital, Cambridge

Cambridge, United Kingdom

Recruiting
Site contact (verified)
Tristan BarrettPrincipal Investigator

Cumberland Infirmary

Carlisle CA2 7HY, United Kingdom

Recruiting
Site contact (verified)
Kathie WongPrincipal Investigator

St Peters Hospital

Chertsey, United Kingdom

Recruiting
Site contact (verified)
Nimalan ArumainayagamPrincipal Investigator

Darent valley Hospital

Dartford DA2 8DA, United Kingdom

Recruiting
Site contact (verified)
Sanjeev MadaanPrincipal Investigator

Northwick Park Hospital

Harrow, United Kingdom

Recruiting
Site contact (verified)
Gaurav MukerjiPrincipal Investigator

St James's Hospital, Leeds

Leeds, United Kingdom

Recruiting
Site contact (verified)
Oliver HulsonPrincipal Investigator

Charing Cross Hospial

London W6 8RF, United Kingdom

Recruiting
Site contact (verified)
Hashim Ahmed, FRCSPrincipal Investigator
Francesca Rawlinsf.rawlins@imperial.ac.uk

Manchester Royal Infirmary

Manchester, United Kingdom

Recruiting
Site contact (verified)
Amar Mr MoheePrincipal Investigator

Northampton General Hospital

Northampton, United Kingdom

Recruiting
Site contact (verified)
Aakash PaiPrincipal Investigator

Hillingdon Hospital

Uxbridge UB8 3NN, United Kingdom

Recruiting
Site contact (verified)
Saheel MukhtarPrincipal Investigator

How to Get in Touch

Hashim Ahmed

Sponsor contact

CONTACT

0203 311 1673 hashim.ahmed@imperial.ac.uk

Thiagarajah Sasikaran

Sponsor contact

CONTACT

0207 594 6017 t.sasikaran@imperial.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-07