Prostate Imaging Using MRI +/- Contrast Enhancement

NCT04571840 · tracked via the Priya Life Science Canada tracker

Sponsor

University College, London

Phase

Not applicable

Started

2022-03-22

Last updated

2024-09-23

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Multiparametric MRI +/- prostate biopsyBiparametric MRI +/- prostate biopsy

Multiparametric MRI +/- prostate biopsy: MRI with T2-weighted, diffusion weighted and dynamic contrast enhanced sequences followed by prostate biopsy if indicated on MRI and clinical findings

Biparametric MRI +/- prostate biopsy: MRI with T2-weighted and diffusion weighted sequences followed by prostate biopsy if indicated on MRI and clinical findings

Study summary

This prospective clinical trial (PRostate Imaging using Mri +/- contrast Enhancement (PRIME)) aims to assess whether biparametric MRI (bpMRI) is non-inferior to multiparametric mpMRI (mpMRI) in the detection of clinically significant prostate cancer.

This means that we are comparing MRI scans that requires injection of IV contrast (the current standard practice) versus MRI scans that can be performed without IV contrast in the detection of prostate cancer.

Eligibility

Sex

MALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Men at least 18 years of age referred with clinical suspicion of prostate cancer 2. Serum PSA ≤ 20ng/ml 3. Fit to undergo all procedures listed in protocol 4. Able to provide written informed consent Exclusion Criteria: 1. Prior prostate biopsy 2. Prior treatment for prostate cancer 3. Prior prostate MRI on a previous encounter 4. Contraindication to MRI 5. Contraindication to prostate biopsy 6. Unfit to undergo any procedures listed in protocol

Primary outcome measure(s)

Proportion of men with clinically significant cancer — When biopsy results available, at an expected average of 30 days post-biopsy

Trial sites (31)

Facility	City	Region
Mayo Clinic	Rochester	Minnesota
NYU Langone	New York	New York
Icahn School of Medicine (Mount Sinai)	New York	New York
New York Presbyterian Hospital	New York	New York
Centro de Urologia	Buenos Aires	Argentina
Monash University	Melbourne	Australia
Peter MacCallum Cancer Centre	Melbourne E.	Australia
Ghent University Hospital	Ghent	Belgium
Hospital Sírio-Libanês	São Paulo	Brazil
Princess Margaret Cancer Centre	Toronto	Canada
Herlev and Gentofte Hospital	Copenhagen	Denmark
Helsinki University Hospital	Helsinki	Finland
Bordeaux Pellegrin University Hospital	Bordeaux	France
CHU Lille	Lille	France
Sorbonne Université	Paris	France
Heinrich Heine University Düsseldorf	Düsseldorf	Germany
Essen University Hospital	Essen	Germany
University Hospital Frankfurt	Frankfurt	Germany
Martini Klinik	Hamburg	Germany
San Raffaele Hospital	Milan	Italy
Sapienza University	Rome	Italy
San Giovanni Battista Hospital	Turin	Italy
University Hospital of Udine	Udine	Italy
Radboudumc	Nijmegen	Netherlands
Tan Tock Seng Hospital	Novena	Singapore
Hospital Universitario Reina Sofía	Córdoba	Spain
Hospital Universitario La Moraleja	Madrid	Spain
Addenbrooke's Hospital	Cambridge	United Kingdom
Royal Free London NHS Foundation Trust	London	United Kingdom
University College London and University College London Hospital	London	United Kingdom
Whittington Hospital	London	United Kingdom

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04571840 on ClinicalTrials.gov ↗ ← All trials in Canada