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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
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

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Basingstoke Hospital
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BasingstokeUnited KingdomRecruiting
Southmead Hospital
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BristolUnited KingdomRecruiting
Addenbrooke Hospital, Cambridge
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CambridgeUnited KingdomRecruiting
Cumberland Infirmary
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CarlisleUnited KingdomRecruiting
St Peters Hospital
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ChertseyUnited KingdomRecruiting
Darent Valley Hospital
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DartfordUnited KingdomRecruiting
Medway Maritime Hospital
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GillinghamUnited KingdomNot yet recruiting
Northwick Park Hospital
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HarrowUnited KingdomRecruiting
St James's Hospital, Leeds
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LeedsUnited KingdomRecruiting
Charing Cross Hospial
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LondonUnited KingdomRecruiting
Manchester Royal Infirmary
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ManchesterUnited KingdomRecruiting
Northampton General Hospital
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NorthamptonUnited KingdomRecruiting
University Hospital Southampton
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SouthamptonUnited KingdomRecruiting
Southend University Hospital
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Southend-on-SeaUnited KingdomRecruiting
Hillingdon Hospital
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UxbridgeUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.