Prostate Imaging Using MRI +/- Contrast Enhancement

NCT04571840 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 135819
• Study Type: interventional
• Target: 500
• Locations: 15 countries
• Sites: 31

Brief 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.

Conditions

Prostate Cancer

Keywords

mri; biopsy; targeted; diagnosis; multiparametric; biparametric

Outcome Measures

Primary Outcomes (1)

• Proportion of men with clinically significant cancer

  When biopsy results available, at an expected average of 30 days post-biopsy

Secondary Outcomes (7)

• Proportion of men with clinically insignificant cancer (Gleason grade 3+3 / Gleason grade group 1)

  When biopsy results available, at an expected average of 30 days post-biopsy

• Agreement between bpMRI and mpMRI for score of suspicion

  When MRI results available, at an expected average of 30 days post-MRI

• Agreement between bpMRI and mpMRI for radiological staging decision

  When MRI results available, at an expected average of 30 days post-MRI

• Agreement between bpMRI and mpMRI for treatment eligibility

  When treatment options discussed in multidisciplinary meeting, at an expected average of 30 days post intervention

• Test performance characteristics for bpMRI & mpMRI when using the Likert scoring system in comparison to the PIRADS scoring system

  When biopsy results available, at an expected average of 30 days post-MRI

Study Arms (2)

mpMRI

ACTIVE COMPARATOR

Multiparametric MRI

Diagnostic Test: Multiparametric MRI +/- prostate biopsy

bpMRI

EXPERIMENTAL

Biparametric MRI

Diagnostic Test: Biparametric MRI +/- prostate biopsy

Interventions

Multiparametric MRI +/- prostate biopsy DIAGNOSTIC_TEST

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

mpMRI

Biparametric MRI +/- prostate biopsy DIAGNOSTIC_TEST

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

bpMRI

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men at least 18 years of age referred with clinical suspicion of prostate cancer
• Serum PSA ≤ 20ng/ml
• Fit to undergo all procedures listed in protocol
• Able to provide written informed consent

You may not qualify if:

• Prior prostate biopsy
• Prior treatment for prostate cancer
• Prior prostate MRI on a previous encounter
• Contraindication to MRI
• Contraindication to prostate biopsy
• Unfit to undergo any procedures listed in protocol

Sponsors & Collaborators

• University College, London: lead

Study Sites (31)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

NYU Langone

New York, New York, 10016, United States

Location

Icahn School of Medicine (Mount Sinai)

New York, New York, 10029, United States

Location

New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Centro de Urologia

Buenos Aires, Argentina

Location

Monash University

Melbourne, Australia

Location

Peter MacCallum Cancer Centre

Melbourne E., Australia

Location

Ghent University Hospital

Ghent, Belgium

Location

Hospital Sírio-Libanês

São Paulo, Brazil

Location

Princess Margaret Cancer Centre

Toronto, Canada

Location

Herlev and Gentofte Hospital

Copenhagen, Denmark

Location

Helsinki University Hospital

Helsinki, Finland

Location

Bordeaux Pellegrin University Hospital

Bordeaux, France

Location

CHU Lille

Lille, France

Location

Sorbonne Université

Paris, France

Location

Heinrich Heine University Düsseldorf

Düsseldorf, Germany

Location

Essen University Hospital

Essen, Germany

Location

University Hospital Frankfurt

Frankfurt, Germany

Location

Martini Klinik

Hamburg, Germany

Location

San Raffaele Hospital

Milan, Italy

Location

Sapienza University

Rome, Italy

Location

San Giovanni Battista Hospital

Turin, Italy

Location

University Hospital of Udine

Udine, Italy

Location

Radboudumc

Nijmegen, Netherlands

Location

Tan Tock Seng Hospital

Novena, Singapore

Location

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Hospital Universitario La Moraleja

Madrid, Spain

Location

Addenbrooke's Hospital

Cambridge, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, United Kingdom

Location

University College London and University College London Hospital

London, United Kingdom

Location

Whittington Hospital

London, United Kingdom

Location

Related Publications (4)

• Ng ABCD, Asif A, Agarwal R, Panebianco V, Girometti R, Ghai S, Gomez-Gomez E, Budaus L, Barrett T, Radtke JP, Kesch C, De Cobelli F, Pham T, Taneja SS, Hu JC, Tewari A, Rodriguez Cabello MA, Dias AB, Mynderse LA, Borghi M, Boesen L, Singh P, Renard-Penna R, Leow JJ, Falkenbach F, Pecoraro M, Giannarini G, Perlis N, Lopez-Ruiz D, Kastner C, Schimmoller L, Rossiter M, Nathan A, Khetrapal P, Chan VW, Haider A, Clarke CS, Punwani S, Brew-Graves C, Dickinson L, Mitra A, Brembilla G, Margolis DJA, Takwoingi Y, Emberton M, Allen C, Giganti F, Moore CM, Kasivisvanathan V; PRIME Study Group Collaborators. Biparametric vs Multiparametric MRI for Prostate Cancer Diagnosis: The PRIME Diagnostic Clinical Trial. JAMA. 2025 Oct 7;334(13):1170-1179. doi: 10.1001/jama.2025.13722.

  PMID: 40928788 DERIVED

• Giganti F, Ng A, Asif A, Chan VW, Rossiter M, Nathan A, Khetrapal P, Dickinson L, Punwani S, Brew-Graves C, Freeman A, Emberton M, Moore CM, Allen C, Kasivisvanathan V; PRIME Quality Improvement Group. Global Variation in Magnetic Resonance Imaging Quality of the Prostate. Radiology. 2023 Oct;309(1):e231130. doi: 10.1148/radiol.231130.

  PMID: 37815448 DERIVED

• Asif A, Nathan A, Ng A, Khetrapal P, Chan VW, Giganti F, Allen C, Freeman A, Punwani S, Lorgelly P, Clarke CS, Brew-Graves C, Muirhead N, Emberton M, Agarwal R, Takwoingi Y, Deeks JJ, Moore CM, Kasivisvanathan V; PRIME Trial Group. Comparing biparametric to multiparametric MRI in the diagnosis of clinically significant prostate cancer in biopsy-naive men (PRIME): a prospective, international, multicentre, non-inferiority within-patient, diagnostic yield trial protocol. BMJ Open. 2023 Apr 5;13(4):e070280. doi: 10.1136/bmjopen-2022-070280.

  PMID: 37019486 DERIVED

• Ng A, Khetrapal P, Kasivisvanathan V. Is It PRIME Time for Biparametric Magnetic Resonance Imaging in Prostate Cancer Diagnosis? Eur Urol. 2022 Jul;82(1):1-2. doi: 10.1016/j.eururo.2022.02.021. Epub 2022 Mar 8.

  PMID: 35277288 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Veeru Kasivisvanathan, MBBS PhD

  University College, London

  STUDY CHAIR

• Caroline Moore, MD FRCS

  University College, London

  PRINCIPAL INVESTIGATOR

• Mark Emberton, MD FRCS

  University College, London

  PRINCIPAL INVESTIGATOR

• Clare Allen, FRCR

  University College London Hospital

  PRINCIPAL INVESTIGATOR

• Shonit Punwani, PhD FRCR

  University College, London

  PRINCIPAL INVESTIGATOR

• Francesco Giganti, MD

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Radiologist assessing MRI for suspicion of prostate cancer is blinded to the contrast sequence when reporting the biparametric MRI. After this report, they are unblinded to the contrast sequence and report the multiparametric MRI. All biopsies conducted as a result of MRI findings will be labelled as bpMRI and mpMRI, and diagnostic accuracy will be assessed against histology findings.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within-person controlled, paired cohort, diagnostic evaluation study. Participants undergo two index tests and a reference test.

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: October 1, 2020
• Study Start: March 22, 2022
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available 1 year after publication of the main study results.
• Access Criteria: A study steering committee will review all requests for access to the data and will make decisions on whether or not to grant access to bona fide researchers based on the importance of the research question being asked, ensuring analysis is non overlapping with existing analyses and planned analyses.

Locations

NL (1); BR (1); AU (2); CA (1); AR (1); US (4); GB (4); FR (3); DK (1); BE (1); IT (4); DE (4); SG (1); FI (1); ES (2)