Clinical trial NCT04571840: Prostate Imaging Using MRI +/- Contrast Enhancement
Official title: A Study Comparing Bi-parametric MRI to Multi-parametric MRI in the Diagnosis of Clinically Significant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: mri
biopsy
targeted
diagnosis
multiparametric
biparametric
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Within-person controlled, paired cohort, diagnostic evaluation study. Participants undergo two index tests and a reference test.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Proportion of men with clinically significant cancer
timeFrame: When biopsy results available, at an expected average of 30 days post-biopsy
Secondary outcomes:
measure: Proportion of men with clinically insignificant cancer (Gleason grade 3+3 / Gleason grade group 1)
timeFrame: When biopsy results available, at an expected average of 30 days post-biopsy
measure: Agreement between bpMRI and mpMRI for score of suspicion
timeFrame: When MRI results available, at an expected average of 30 days post-MRI
measure: Agreement between bpMRI and mpMRI for radiological staging decision
timeFrame: When MRI results available, at an expected average of 30 days post-MRI
measure: Agreement between bpMRI and mpMRI for treatment eligibility
timeFrame: When treatment options discussed in multidisciplinary meeting, at an expected average of 30 days post intervention
measure: Test performance characteristics for bpMRI & mpMRI when using the Likert scoring system in comparison to the PIRADS scoring system
timeFrame: When biopsy results available, at an expected average of 30 days post-MRI
measure: Proportion of men with cancer missed by bpMRI and mpMRI-targeted biopsies and detected by systematic biopsy
timeFrame: When biopsy results available, at an expected average of 30 days post-biopsy
measure: Cost-effectiveness of BpMRI compared to mpMRI (cost per diagnosis of prostate cancer)
timeFrame: At an expected average of 30 days post-intervention
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: NYU Langone
state: New York
city: New York
country: United States
facility: Icahn School of Medicine (Mount Sinai)
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Buenos Aires
country: Argentina
facility: Centro de Urologia
city: Melbourne E.
country: Australia
facility: Peter MacCallum Cancer Centre
city: Melbourne
country: Australia
facility: Monash University
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: São Paulo
country: Brazil
facility: Hospital Sírio-Libanês
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
city: Copenhagen
country: Denmark
facility: Herlev and Gentofte Hospital
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Bordeaux
country: France
facility: Bordeaux Pellegrin University Hospital
city: Lille
country: France
facility: CHU Lille
city: Paris
country: France
facility: Sorbonne Université
city: Düsseldorf
country: Germany
facility: Heinrich Heine University Düsseldorf
city: Essen
country: Germany
facility: Essen University Hospital
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
city: Hamburg
country: Germany
facility: Martini Klinik
city: Milan
country: Italy
facility: San Raffaele Hospital
city: Rome
country: Italy
facility: Sapienza University
city: Turin
country: Italy
facility: San Giovanni Battista Hospital
city: Udine
country: Italy
facility: University Hospital of Udine
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Novena
country: Singapore
facility: Tan Tock Seng Hospital
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Madrid
country: Spain
facility: Hospital Universitario La Moraleja
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: London
country: United Kingdom
facility: University College London and University College London Hospital
city: London
country: United Kingdom
facility: Whittington Hospital
Study officials:
affiliation: University College, London
name: Veeru Kasivisvanathan, MBBS PhD
role: STUDY_CHAIR
affiliation: University College, London
name: Caroline Moore, MD FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: University College, London
name: Mark Emberton, MD FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: University College London Hospital
name: Clare Allen, FRCR
role: PRINCIPAL_INVESTIGATOR
affiliation: University College, London
name: Shonit Punwani, PhD FRCR
role: PRINCIPAL_INVESTIGATOR
affiliation: University College, London
name: Francesco Giganti, MD
role: PRINCIPAL_INVESTIGATOR
References: