NCT05574647Recruiting
Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer
Evaluating the Role of Biparametric MRI and Image-fusion Targeted Biopsies for Detection of Prostate Cancer
Source: ClinicalTrials.gov · Last updated 24 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 3600 (estimated)
- First submitted
- 3 Aug 2022
- Start date
- 2 Nov 2022
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- Imperial College London
- Diseases
- Prostate cancer
- NCT number
- NCT05574647
What you commit to
- Study type: Interventional
- Planned participants: 3600
- From 2 Nov 2022 to the primary completion date, 31 Oct 2025
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior prostate MRI or prostate biopsy in the two years prior to screening visit
- Prior diagnosis of prostate cancer
- Previous hip replacement to both hips
Other
- PSA \>50ng/ml
- Contraindication to MRI or gadolinium contrast
- Contraindication to performing a biopsy guided by a transrectal ultrasound probe
- Randomisation 2
- As above for randomisation 1
- Patient refusal for biopsy
Who 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 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
- 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)
Criteria the registry did not label
- Randomisation 1
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Basingstoke Hospital Coordinator of this site? Confirm its status | Basingstoke | United Kingdom | Recruiting |
| Southmead Hospital Coordinator of this site? Confirm its status | Bristol | United Kingdom | Recruiting |
| Addenbrooke Hospital, Cambridge Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| Cumberland Infirmary Coordinator of this site? Confirm its status | Carlisle | United Kingdom | Recruiting |
| St Peters Hospital Coordinator of this site? Confirm its status | Chertsey | United Kingdom | Recruiting |
| Darent Valley Hospital Coordinator of this site? Confirm its status | Dartford | United Kingdom | Recruiting |
| Medway Maritime Hospital Coordinator of this site? Confirm its status | Gillingham | United Kingdom | Not yet recruiting |
| Northwick Park Hospital Coordinator of this site? Confirm its status | Harrow | United Kingdom | Recruiting |
| St James's Hospital, Leeds Coordinator of this site? Confirm its status | Leeds | United Kingdom | Recruiting |
| Charing Cross Hospial Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Manchester Royal Infirmary Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Northampton General Hospital Coordinator of this site? Confirm its status | Northampton | United Kingdom | Recruiting |
| University Hospital Southampton Coordinator of this site? Confirm its status | Southampton | United Kingdom | Recruiting |
| Southend University Hospital Coordinator of this site? Confirm its status | Southend-on-Sea | United Kingdom | Recruiting |
| Hillingdon Hospital Coordinator of this site? Confirm its status | Uxbridge | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.