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
Italy
Sapienza University of Rome University Hospital of Udine
Germany The Martini -Klinik
PI: Lars Budaeus
PRIME Chief Investigator London (GB)
Spain
University Hospital Reina Sofia
Co-PI: Enrique Gómez Gómez Co-PI: Daniel José López Ruiz
UK
Addenbrooke’s Hospital
Co-PI: Tristan Barrett Co-PI: Christof Kastner
Sites that are currently recruiting: Argentina Centro de Urologia CDU
@veerukasi
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,
Brazil
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 .
Canada
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
Italy
San Raffaele Hospital
PI: Alberto Briganti
Spain
University Hospital La Moraleja
Co-PI: Miguel Angel Rodríguez Cabello Co-PI: Carolina Aulló Gonzanlez
Figure 1: Simplified PRIME study schema
UK
University College London Hospital
Co-PI: Veeru Kasivisvanathan Co-PI: Caroline Moore
Royal Free Hospital Mayo Clinic, Rochester
PI: Paras Singh
USA
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: https://www.ucl.ac.uk/surgery/ 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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