European Urology Today: June/July 2023

A 14-month update on the PRIME Trial PRostate Imaging using MRI ± contrast Enhancement

Sites that have met the target recruitment number of 30 patients: Country Site

Assoc. Prof. Veeru Kasivisvanathan University College London and UCLH

Principal Investigator(s) PI: Valeria Panebianco


Sapienza University of Rome University Hospital of Udine

Germany The Martini -Klinik

PI: Lars Budaeus

PRIME Chief Investigator London (GB)


University Hospital Reina Sofia

Co-PI: Enrique Gómez Gómez Co-PI: Daniel José López Ruiz


Addenbrooke’s Hospital

Co-PI: Tristan Barrett Co-PI: Christof Kastner

Sites that are currently recruiting: Argentina Centro de Urologia CDU


Co-PI: Marcelo Borghi Co-PI: Hernando Rios Pita Co-PI: Jeremy Grummet Co-PI: Richard O’Sullivan

Australia Alfred Health, Monash University

Study design: PRIME (NCT04571840) is a prospective, international, within-patient,


Hospital Sírio LibanêsSirio-Libanes

Co-PI: Publio Cesar Cavalcante Viana Co-PI: Adriano Basso Dias

multicentre, level 1–evidence clinical trial evaluating whether biparametric MRI (bpMRI) is noninferior to mpMRI in the detection of clinically significant prostate cancer (csPCa). Men with clinical suspicion of PCa undergo mpMRI as per standard of care. The dynamic contrast-enhanced imaging (DCE) sequence is then blinded from the radiologists to report the bpMRI. The DCE sequence will then be unblinded to the radiologist to report the full mpMRI. All MRI scans are reported using Likert and PI-RADS v2.1 scores. Patients with non-suspicious MRI (scores 1 or 2) on bpMRI and mpMRI and low risk of PCa will be recommended to undergo PSA surveillance. Patients with suspicious MRI (scores 3,4 or 5) on either bpMRI or mpMRI will undergo MRI-targeted biopsy. Suspicious areas will be labelled with their location and whether they were suspicious on either bpMRI or mpMRI. Targeted biopsy cores will be stored separately from areas that were uniquely suspicious on DCE so that conclusions can be made on whether the pathology was from suspicious areas on the bpMRI or mpMRI or both. Systematic biopsies will also be taken. The simplified study schema is shown below in Figure 1 .


Princess Margaret Cancer Centre

PI: Sangeet Ghai

Germany University Hospital Essen

Co-PI: Claudia Kesch Co-PI: Boris Hadaschik Heinrich Heine University Düusseldorf Co-PI: Jan Philipp Radtke Co-PI: Lars Schimmöller


San Raffaele Hospital

PI: Alberto Briganti


University Hospital La Moraleja

Co-PI: Miguel Angel Rodríguez Cabello Co-PI: Carolina Aulló Gonzanlez

Figure 1: Simplified PRIME study schema


University College London Hospital

Co-PI: Veeru Kasivisvanathan Co-PI: Caroline Moore

Royal Free Hospital Mayo Clinic, Rochester

PI: Paras Singh


PI: Lance A Mynderse

Recent Progress of PRIME Since opening to recruitment in April 2022, the PRIME trial is recruiting ahead of schedule! We are pleased to announce that we have now surpassed the 375-patient mark for recruitment, with 19 sites opened to recruitment from 9 countries (UK, Spain, Germany, Italy, Brazil, Argentina, Australia, Canada and USA). We would like to congratulate and celebrate our international centres, without whom none of this would be possible.

Icahn School of Medicine, Mount Sinai PI: Ash Tewari Weill Cornell Medical Centre

Co-PI: Daniel Margolis Co-PI: Jim Hu PI: Samir S. Taneja

NYU Langone

Table 1. List of sites opened for recruitment

3. Agreement between bpMRI and mpMRI on treatment decision eligibility Implications of PRIME If bpMRI is non-inferior to mpMRI, then bpMRI will become the new standard of care for prostate cancer detection in men with suspected prostate cancer, allowing for a greater capacity to deliver MRI scans to meet the demand.

Primary outcome: The proportion of men with csPCa detected (Gleason Grade ≥ 3+4) / Gleason grade group 2 or greater). Key secondary outcomes: 1. Agreement between bpMRI and mpMRI in score of suspicion 2. Proportion of men with clinically insignificant cancer detected (Gleason grade 3+3 / Gleason grade group 1) and;

Study website: research/department-targeted-intervention/

urology/prime-trial-information Follow us on Twitter @PrimeMRI!

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European Urology Today June/July 2023


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