Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT05574647

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

Led by Imperial College London · Updated on 2025-07-24

3600

Participants Needed

15

Research Sites

169 weeks

Total Duration

On this page

Sponsors

I

Imperial College London

Lead Sponsor

C

Cancer Research UK

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or above (no upper limit)
  • Male patients with a prostate (cis-male or trans-female with no prior androgen deprivation hormone use)
  • Referred for prostate MRI due to abnormal digital rectal exam and/or elevated PSA within 6 months
  • PSA thresholds:
    • 5B3 3.0ng/ml for ages 50-69
    • 5B3 5.0ng/ml for age 5B3 70
    • 5B3 2.5ng/ml for ages 45-49 with family or ethnic risk
  • Visible suspicious finding on mpMRI or bpMRI requiring targeted biopsy (MRI score 3, 4, or 5)
Not Eligible

You will not qualify if you...

  • PSA > 50ng/ml
  • Prior prostate MRI or biopsy within 2 years
  • Previous diagnosis of prostate cancer
  • Contraindication to MRI or gadolinium contrast
  • Previous hip replacement in both hips
  • Contraindication to biopsy guided by transrectal ultrasound
  • Patient refusal for biopsy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

Southend University Hospital

Southend-on-Sea, Essex, United Kingdom, SS0 0RY

Actively Recruiting

2

University Hospital Southampton

Southampton, Hampshire, United Kingdom, SO16 6YD

Actively Recruiting

3

Medway Maritime Hospital

Gillingham, Kent, United Kingdom, ME7 5NY

Not Yet Recruiting

4

Basingstoke Hospital

Basingstoke, United Kingdom, RG24 9NA

Actively Recruiting

5

Southmead Hospital

Bristol, United Kingdom, BS10 5NB

Actively Recruiting

6

Addenbrooke Hospital, Cambridge

Cambridge, United Kingdom

Actively Recruiting

7

Cumberland Infirmary

Carlisle, United Kingdom, CA2 7HY

Actively Recruiting

8

St Peters Hospital

Chertsey, United Kingdom

Actively Recruiting

9

Darent valley Hospital

Dartford, United Kingdom, DA2 8DA

Actively Recruiting

10

Northwick Park Hospital

Harrow, United Kingdom

Actively Recruiting

11

St James's Hospital, Leeds

Leeds, United Kingdom

Actively Recruiting

12

Charing Cross Hospial

London, United Kingdom, W6 8RF

Actively Recruiting

13

Manchester Royal Infirmary

Manchester, United Kingdom

Actively Recruiting

14

Northampton General Hospital

Northampton, United Kingdom

Actively Recruiting

15

Hillingdon Hospital

Uxbridge, United Kingdom, UB8 3NN

Actively Recruiting

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Research Team

H

Hashim Ahmed

CONTACT

T

Thiagarajah Sasikaran

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

4

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