A 12-month update on the PRIME Trial 'PRostate Imaging using MRI ± contrast Enhancement' study well on its way

Assoc. Prof. Veeru Kasivisvanathan University College

London and UCLH

PRIME Chief Investigator

London (GB)

@veerukasi

Dr. Aqua Asif University College

London

PRIME Research Assistant London (GB)

@AquaAsif

Dr. Alexander Ng University College

London

PRIME Research Assistant

London (GB)

@AlexBCDNg

Ms. Marimo Rossiter University College

London

PRIME Research Assistant London (GB)

@MarimoRossiter

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

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;

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 PCa detection in men with suspected PCa, allowing for a greater capacity to deliver MRI scans to meet the demand.

First Prize for Best Abstract

Our team has been recognised by the European Association of Urology (EAU) 2023 with a prestigious prize during its Annual Congress, which took place in Milan, Italy. First author, Dr. Alexander Ng, received the First Prize for Best Abstract by a Resident in Urology, for their research into prostate MRI quality. This year, there were just under 5,000 abstract submissions, and of course, this is regarded as one of the biggest international urology meetings.

The GLIMPSE study, which analysed the MRI quality control phase from the ongoing international multi-centre PRIME study, evaluated whether biparametric MRI is non-inferior to multiparametric MRI in the detection of significant PCa. We carried out the first global overview into the variation of prostate MR image quality. Initial MRI quality was fair, with room for improvement, particularly with DCE imaging. With very basic changes in line with PI-RADS recommendations, global MRI quality can be easily improved.

Commenting on the award, Dr. Ng said: “I’m extremely honoured and privileged to receive the first prize for best abstract by resident in urology. I would like to say thank you to my colleagues, supervisors, mentors, and family, as we aim to ensure that all men who require an MRI can get access.”

Chief Investigator, Assoc. Prof. Veeru Kasivisvanathan (GB) said: “This represents the hard work and dedication of the PRIME team and our international collaborators. This achievement showcases the bright future of academic urology and the power of collaboration in advancing medical research.”

Dr. Asif added, "I am truly grateful for the unwavering support and dedication of our international collaborators, mentors, peers, and loved ones, who have all played a crucial role in our success. Our collective efforts are helping break down barriers to accessing MRI, ultimately improving the lives of countless men around the world. I am proud to be part of this incredible team, and I firmly believe that together, we can continue to make a positive impact."

PRIME Investigators’ Meeting at EAU23

The PRIME team recently held a hybrid-style PRIME Investigator’s Meeting at EAU23 in Milan, Italy. It was wonderful to see so many brilliant international minds come together, as our investigators joined us both in person and online. During the meeting, we provided a study update, built on last year's ideas, and explored future study ideas, all while fostering a collaborative and inspiring atmosphere.

Recent Progress of PRIME https://www.ucl.ac.uk/surgery/research/ department-targeted-intervention/urology/ prime-trial-information

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 300-patient mark for recruitment, with 18 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.

Follow us on Twitter @PrimeMRI!

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

Country Site

Italy Sapienza University of Rome

University Hospital of Udine

Germany The Martini-Klinik

Spain University Hospital Reina Sofia

Principal Investigator(s)

PI: Valeria Panebianco

PI: Rossano Girometti

PI: Lars Budaeus

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

Co-PI: Marcelo Borghi Co-PI: Hernando Rios Pita

Australia Alfred Health, Monash University Co-PI: Jeremy Grummet Co-PI: Richard O'Sullivan

Brazil Hospital Sírio Libanês Co-PI: Publio Cesar Cavalcante Viana Co-PI: Adriano Basso Dias

Canada Princess Margaret Cancer Centre PI: Sangeet Ghai

Germany University Hospital Essen Co-PI: Claudia Kesch Co-PI: Boris Hadaschik

Heinrich Heine University Düsseldorf 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

UK University College London Hospital Co-PI: Veeru Kasivisvanathan

Co-PI: Caroline Moore

Royal Free Hospital PI: Paras Singh

USA Mayo Clinic, Rochester PI: Lance A. Mynderse

Icahn School of Medicine, Mount Sinai PI: Ash Tewari

Weill Cornell Medical Centre

Country Site

Co-PI: Daniel Margolis

Co-PI: Jim Hu

Principal Investigator(s)

Australia Peter MacCallum Cancer Centre PI: Declan Murphy

Belgium Ghent University Hospital PI: Pieter De Fisschere

Denmark Herlev Gentofte University Hospital PI: Lars Boesen

France Sorbonne Université PI: Raphaele Renard-Penna

Centre Hospitalier Universitaire de Bordeaux PI: Gregoire Robert

Centre Hospitalier Universitaire de Lille PI: Philippe Puech

Germany University Hospital Frankfurt Co-PI: Mike Wenzel Co-PI: Felix Chun

Italy San Giovanni Battista Hospital Co-PI: Giancarlo Marra Co-PI: Marco Gatti

Netherlands Radboud University Medical Centre Co-PI: Maarten De Rooij

Co-PI: Bas Israël

Singapore Tan Tock Seng Hospital PI: Jeffrey J. Leow

USA NYU Langone PI: Samir S. Taneja

MD Anderson PI: Tharak Bathala

UK Lister Hospital PI: Nikhil Vasdev