NEWPROMRI-PATHWAY - A New Prostate Magnetic Resonance Imaging (MRI) Pathway

NCT06672926 | Recruiting

• 1 other identifier: 3320
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate cancer is the second most common cancer in men worldwide. The demand for magnetic resonance imaging (MRI) to diagnose and manage prostate cancer is continually growing. There is, however, a severe global shortage of radiologists who review and make decisions on prostate scans. This shortage causes compromises that are inefficient and negatively affect care provision, patient outcomes, and patient experiences. Two key examples of these compromises are that every patient receives a gadolinium contrast injection during a prostate MRI scan and patients often require multiple imaging appointments. If radiologists' knowledge of making prostate MRI decisions around these compromises could be harnessed and passed to radiographers (who are trained to acquire the MRIs but currently do not review them) with a computerised system to support clinical decision-making, this would have enormous potential to improve the diagnosing and managing prostate cancer.

Conditions

Prostate Cancer; MRI

Outcome Measures

Primary Outcomes (3)

• Use of Gadolinium Based Contrast Agent (GBCA) injection

  Equivalence between radiographers and radiologists in deciding when Gadolinium Based Contrast Agent (GBCA) injection is required in prostate MRI scans. This is by comparing radiographers' diagnoses (decisions on whether GBCA injection would have been required) with radiologists' decisions to determine equivalence in prostate cancer diagnosis using prostate MRI.

  12 months

• Application of WB-MRI

  Equivalence between radiographers and radiologists in deciding when WB-MRI is required in prostate MRI scans. This is by comparing radiographers' decisions (decisions on whether WB-MRI would have been required) with radiologists' decisions to determine equivalence in prostate cancer diagnosis using prostate MRI.

  12 months

• Radiographers opinions

  The Decisional Conflict Scale (DCS) will be used to capture radiographers' opinions on how they felt about the tasks and support they are given during their preparation and afterward

  12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Uro-radiologists will be asked to take part, along with radiographers and members of a prostate cancer charity group

You may qualify if:

• MRI radiographers in University Hospitals of North Midlands (UHNM) and or University Hospitals of Derby and Burton (UHDB) with over 5 years' experience in MRI of the prostate.
• Radiographers from UHNM or UHDB who have completed an online and hands on study specific training materials before the testing phase.
• Retrospective data of 800 patients each from UHNM and UHDB who have had mpMRI and went on to have a biopsy.

You may not qualify if:

• Non-MRI radiographers.
• Radiographers who did not completed an online and hands on study specific training materials before the testing phase.
• Non-mpMRI.

Sponsors & Collaborators

• University Hospitals of North Midlands NHS Trust: lead

Study Sites (1)

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Aviva Ogbolosingha

CONTACT

01782 675380; aviva.ogbolosingha@uhnm.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: November 4, 2024
• Study Start: September 23, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

GB (1)