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

NCT05574647 | Recruiting DMC

• 1 other identifier: 22CX7488
• Study Type: interventional
• Target: 3,600
• Locations: 1 country
• Sites: 15

Brief Summary

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

Prostate Cancer; Adenocarcinoma; Prostatic Neoplasms; Prostatic Diseases; Neoplasms

Keywords

Prostate Cancer; Prostate-Specific Antigen; bpMRI; mpMRI; Prostate biopsy; Multi-parametric MRI; Biparametric MRI

Outcome Measures

Primary Outcomes (2)

• Randomisation 1: Proportion of clinically significant cancers detected in the randomised population of patients at risk.

  Proportion of clinically significant cancers, defined as any amount of Gleason ≥3+4 (ISUP Grade Group ≥2) on biopsy, detected in the randomised population of patients at risk.

  maximum 12 weeks following enrolment

• Randomisation 2: Proportion of clinically significant cancers detected in the randomised population of patients biopsied for a suspicious MRI.

  Proportion of clinically significant cancers, defined as any amount of Gleason ≥3+4 (ISUP Grade Group ≥2) on biopsy, detected in the randomised population of patients biopsied for a suspicious MRI.

  maximum 12 weeks following enrolment

Secondary Outcomes (22)

• MRI related adverse events

  maximum 12 weeks following enrolment

• MRI related serious adverse events

  maximum 12 weeks following enrolment

• Biopsy related adverse events

  maximum 12 weeks following enrolment

• Biopsy related serious adverse events

  maximum 12 weeks following enrolment

• The proportion of patients advised to undergo a needle biopsy after MRI

  maximum 12 weeks following enrolment

Study Arms (4)

Standard: mpMRI

NO INTERVENTION

Participants will undergo mpMRI. Blinding will not be possible. Once the MRI report is issued, the local clinical team will make a decision about advising whether a biopsy is necessary or not.

Intervention 1: bpMRI

ACTIVE COMPARATOR

Participants will undergo bpMRI. Blinding will not be possible. Once the MRI report is issued, the local clinical team will make a decision about advising whether a biopsy is necessary or not.

Diagnostic Test: bpMRI

Standard: Visual estimation targeted and systematic biopsy

NO INTERVENTION

Randomisation 2 will only be relevant if participants are advised by their clinical team to have a biopsy based on their MRI and other clinical factors. Participants advised to have a biopsy will undergo a visual estimation targeted biopsy

Intervention 2: Image-fusion targeted and systematic biopsy

ACTIVE COMPARATOR

Randomisation 2 will only be relevant if participants are advised by their clinical team to have a biopsy based on their MRI and other clinical factors. Participants advised to have a biopsy will undergo an image fusion targeted biopsy.

Diagnostic Test: Image-Fusion targeted and systematic Biopsy

Interventions

bpMRI DIAGNOSTIC_TEST

biparametric MRI takes 30-40 minutes and requires a contrast injection called gadolinium (like a dye). This is also called long MRI and is most commonly used in the NHS.

Also known as: biparametric MRI

Intervention 1: bpMRI

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. 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.

Intervention 2: Image-fusion targeted and systematic biopsy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients with a prostate (either cis-male gender or trans-female gender with no prior androgen deprivation hormone use at all)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)
• As above for randomisation 1
• Patient refusal for biopsy

Sponsors & Collaborators

• Imperial College London: lead
• Cancer Research UK: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (15)

Southend University Hospital

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

RECRUITING

University Hospital Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

Medway Maritime Hospital

Gillingham, Kent, ME7 5NY, United Kingdom

NOT YET RECRUITING

Basingstoke Hospital

Basingstoke, RG24 9NA, United Kingdom

RECRUITING

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

RECRUITING

Addenbrooke Hospital, Cambridge

Cambridge, United Kingdom

RECRUITING

Cumberland Infirmary

Carlisle, CA2 7HY, United Kingdom

RECRUITING

St Peters Hospital

Chertsey, United Kingdom

RECRUITING

Darent valley Hospital

Dartford, DA2 8DA, United Kingdom

RECRUITING

Northwick Park Hospital

Harrow, United Kingdom

RECRUITING

St James's Hospital, Leeds

Leeds, United Kingdom

RECRUITING

Charing Cross Hospial

London, W6 8RF, United Kingdom

RECRUITING

Manchester Royal Infirmary

Manchester, United Kingdom

RECRUITING

Northampton General Hospital

Northampton, United Kingdom

RECRUITING

Hillingdon Hospital

Uxbridge, UB8 3NN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma; Prostatic Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Hashim Ahmed

CONTACT

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

Thiagarajah Sasikaran

CONTACT

0207 594 6017; t.sasikaran@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two linked RCTs which will test whether bpMRI and image-fusion make a difference if used in clinical practice, across multiple centres, without the incorporation bias inherent in paired-cohort studies

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: October 10, 2022
• Study Start: November 2, 2022
• Primary Completion: October 31, 2025
• Study Completion: January 31, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (15)