Prostate Imaging Using MRI +/- Contrast Enhancement

NCT ID: NCT04571840

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-22
• Study Completion Date: 2025-03-01

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.

Detailed Description

The PRECISION study (NCT02380027) has established that multiparametric MRI +/- targeted biopsy of suspicious areas identified on MRI is superior to standard 12 core TRUS biopsy in the detection of clinically significant prostate cancer (Gleason > 3+ 4) (38% vs 26%), in reducing the detection of clinically insignificant prostate cancer (Gleason 3 + 3) (9% vs 22%) and in maximising the proportion of cores positive for prostate cancer (44% vs 19%).

Multiparametric MRI (mpMRI) typically uses T2-weighted (T2W), diffusion-weighted (DWI) and dynamic contrast enhanced (DCE) sequences. As a mpMRI is a precious resource, due to capacity and resource limitations, one of the major challenges across institutions is delivering a health service with pre-biopsy MRI before a biopsy in all men with suspected prostate cancer.

However, biparametric MRI (bpMRI), that is, a combination of T2W and DWI, which does not use the DCE sequences, has demonstrated similar detection rates of prostate cancer as mpMRI in some studies and there is a debate about the necessity of the DCE sequence.

The potential advantages of avoiding the DCE sequence include avoiding the cost associated with it, shorter scan time, avoiding the need for medical practitioner attendance, and avoiding putative basal ganglia accumulation and the possibility of adverse neurological effect. Thus, a bpMRI approach may be more feasible and have health-economic benefits over a mpMRI approach and may thus increase the accessibility of this resource to men who need it.

PRIME is a multi-centre study. Men referred with clinical suspicion of prostate cancer based on raised prostate specific antigen (PSA) or abnormal digital rectal examination (DRE) who have had no prior biopsy undergo mpMRI. The DCE sequence is blinded from the radiologist who reports the bpMRI first. After reporting the bpMRI, the DCE sequence is made available to the radiologist who reports the mpMRI. The MRIs and lesions are scored on 1-5 scales of suspicion for the likelihood that clinically significant cancer is present:

1. - Very low (clinically significant cancer is highly unlikely to be present)

2. - Low (clinically significant cancer is unlikely to be present)

3. - Intermediate (the presence of clinically significant cancer is equivocal)

4. - High (clinically significant cancer is likely to be present)

5. - Very high (clinically significant cancer is highly likely to be present)

Men with non-suspicious MRI on bpMRI and mpMRI and low clinical risk of prostate cancer will be counselled by their clinical teams as per routine clinical care. In routine clinical practice these men typically do not undergo prostate biopsy.

Suspicious areas scoring 3, 4 or 5 on either bpMRI or mpMRI will undergo targeted and systematic biopsy using the information from the mpMRI to influence biopsy conduct. Suspicious areas will be labelled by their MRI score, with their location according to sector diagrams.

The proportion of patients with clinically significant prostate cancer will be ascertained and compared between bpMRI and mpMRI.

Treatment eligibility decisions without the DCE information will be made and once the clinicians are unblinded to the DCE sequence the impact that this information makes on the treatment decision will be evaluated.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

mpMRI

Multiparametric MRI

Group Type: ACTIVE_COMPARATOR

Multiparametric MRI +/- prostate biopsy

Intervention Type: DIAGNOSTIC_TEST

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

bpMRI

Biparametric MRI

Group Type: EXPERIMENTAL

Biparametric MRI +/- prostate biopsy

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Biparametric MRI +/- prostate biopsy

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veeru Kasivisvanathan, MBBS PhD

Role: STUDY_CHAIR

University College, London

Caroline Moore, MD FRCS

Role: PRINCIPAL_INVESTIGATOR

University College, London

Mark Emberton, MD FRCS

Role: PRINCIPAL_INVESTIGATOR

University College, London

Clare Allen, FRCR

Role: PRINCIPAL_INVESTIGATOR

University College London Hospital

Shonit Punwani, PhD FRCR

Role: PRINCIPAL_INVESTIGATOR

University College, London

Francesco Giganti, MD

Role: PRINCIPAL_INVESTIGATOR

University College, London

Locations

Mayo Clinic

Rochester, Minnesota, United States

NYU Langone

New York, New York, United States

Icahn School of Medicine (Mount Sinai)

New York, New York, United States

New York Presbyterian Hospital

New York, New York, United States

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

Countries

United States; Argentina; Australia; Belgium; Brazil; Canada; Denmark; Finland; France; Germany; Italy; Netherlands; Singapore; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 40928788 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37815448 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37019486 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35277288 (View on PubMed)

Other Identifiers

135819

Identifier Type: -

Identifier Source: org_study_id