Table 4

WHO trial registration dataset

Data category	Information
Primary registry and trial identifying number	ClinicalTrials.gov: NCT04571840
Date of registration in the primary registry	1 October 2020
Sources of monetary or material support	Prostate Cancer UK. The John Black Charitable Foundation. European Association of Urology Research Foundation. The Dieckmann Foundation.
Primary sponsor	University College London
Secondary sponsor(s)	N/A
Contact for public queries	Mr Veeru Kasivisvanathan veeru.kasi@ucl.ac.uk Division of Surgery and Interventional Science, University College London, Third Floor, Charles Bell House, 43–45 Foley Street, London, W1W 7TS
Contact for scientific queries	Mr Veeru Kasivisvanathan veeru.kasi@ucl.ac.uk Division of Surgery and Interventional Science, University College London, Third Floor, Charles Bell House, 43–45 Foley Street, London, W1W 7TS
Public title/short title	Prostate Imaging Using MRI +/- Contrast Enhancement
Acronym	PRIME
Scientific title	A trial assessing whether bpMRI is non-inferior to multiparametric MRI in the diagnosis of clinically significant PCa
Countries of recruitment	Argentina Australia Belgium Brazil Canada Denmark France Finland Germany Italy The Netherlands Singapore Spain UK USA
Health condition or problem studied	Prostate neoplasm
Interventions	Device: MRI Diagnostic test: multiparametric MRI±prostate biopsy. Diagnostic test: bpMRI±prostate biopsy.
Intervention description	Active comparator: mpMRI. MRI with T2W, DWI and DCE followed by prostate biopsy if indicated on MRI and clinical findings. Diagnostic test: mpMRI±prostate biopsy. Experimental: bpMRI. MRI with T2W and DWI followed by prostate biopsy if indicated on MRI and clinical findings. Diagnostic test: bpMRI±prostate biopsy.
Key inclusion and exclusion criteria	Inclusion criteria Men at least 18 years of age referred with clinical suspicion of PCa. Serum PSA ≤20 ng/mL. Fit to undergo all procedures listed in the protocol. Able to provide written informed consent. Exclusion criteria Prior prostate biopsy. Prior treatment for PCa. Prior prostate MRI on a previous encounter. Contraindication to MRI. Contraindication to prostate biopsy. Unfit to undergo any procedures listed in the protocol.
Study type	Interventional Allocation: non-randomised Intervention model: single group assignment Intervention model description: within-person controlled, paired cohort, diagnostic evaluation study; participants undergo two index tests and a reference test Masking: single (care provider) Masking description: Radiologist assessing MRI for suspicion of PCa is blinded to the contrast sequence when reporting the bpMRI. After this report, they are unblinded to the contrast sequence and report the multiparametric MRI. All biopsies conducted as a result of MRI findings will be labelled as bpMRI and mpMRI, and diagnostic accuracy will be assessed against histological findings.
Date of first enrolment	5 April 2022
Target sample size	500
Recruitment status	Recruiting
Primary outcome(s)	Proportion of men with clinically significant cancer
Key secondary outcomes	Proportion of men with clinically insignificant cancer (Gleason score 3+3/Gleason grade group 1). Agreement between bpMRI and mpMRI for score of suspicion. Proportion of bpMRI scans and mpMRI whose quality was deemed adequate for reporting. Agreement between bpMRI and mpMRI for radiological staging decision. Agreement between bpMRI and mpMRI for treatment eligibility. Test performance characteristics for bpMRI and mpMRI when using the Likert scoring system in comparison to the PI-RADS scoring system. Proportion of men with clinically significant cancer missed by bpMRI and mpMRI-targeted biopsies and detected by systematic biopsy. Cost-effectiveness of bpMRI compared with mpMRI (cost per diagnosis of PCa).

bpMRI, biparametric MRI; DCE, dynamic contrast-enhance sequence; DWI, diffusion-weighted sequence; mpMRI, multiparametric MRI; PCa, prostate cancer; PRIME, Prostate Imaging Using MRI±Contrast Enhancement; T2W, T2-weighted sequence.