Clinical trial · Interventional
Prostate Imaging Using MRI +/- Contrast Enhancement
A Study Comparing Bi-parametric MRI to Multi-parametric MRI in the Diagnosis of Clinically Significant Prostate Cancer
NCT04571840CI-TRIAL-00080980PRIMEactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biparametric MRI +/- prostate biopsy | Diagnostic Test | — | UNRESOLVED |
| Multiparametric MRI +/- prostate biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- mpMRI
- description
- Multiparametric MRI
- interventionNames
- Diagnostic Test: Multiparametric MRI +/- prostate biopsy
- type
- EXPERIMENTAL
- label
- bpMRI
- description
- Biparametric MRI
- interventionNames
- Diagnostic Test: Biparametric MRI +/- prostate biopsy
Primary outcomes (1)
- measure
- Proportion of men with clinically significant cancer
- timeFrame
- When biopsy results available, at an expected average of 30 days post-biopsy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- DERIVEDMicheleto JPC, Suzuki TA, Santos LA, Sales LP, Lopes RI, Martins BM, Aguiar Melao BVL, Cordeiro MD, Sharour W, Shabana W, Nahas WC, Ribeiro Filho LA, Suartz CV. Micro-ultrasonography- vs MRI-targeted biopsy in prostate cancer: Updated systematic review and meta-analysis. BJU Int. 2026 Aug;138(2):196-207. doi: 10.1111/bju.70270. Epub 2026 Apr 16. PMID 41989063
- DERIVEDNg ABCD, Asif A, Agarwal R, Panebianco V, Girometti R, Ghai S, Gomez-Gomez E, Budaus L, Barrett T, Radtke JP, Kesch C, De Cobelli F, Pham T, Taneja SS, Hu JC, Tewari A, Rodriguez Cabello MA, Dias AB, Mynderse LA, Borghi M, Boesen L, Singh P, Renard-Penna R, Leow JJ, Falkenbach F, Pecoraro M, Giannarini G, Perlis N, Lopez-Ruiz D, Kastner C, Schimmoller L, Rossiter M, Nathan A, Khetrapal P, Chan VW, Haider A, Clarke CS, Punwani S, Brew-Graves C, Dickinson L, Mitra A, Brembilla G, Margolis DJA, Takwoingi Y, Emberton M, Allen C, Giganti F, Moore CM, Kasivisvanathan V; PRIME Study Group Collaborators. Biparametric vs Multiparametric MRI for Prostate Cancer Diagnosis: The PRIME Diagnostic Clinical Trial. JAMA. 2025 Oct 7;334(13):1170-1179. doi: 10.1001/jama.2025.13722. PMID 40928788
- DERIVEDGiganti F, Ng A, Asif A, Chan VW, Rossiter M, Nathan A, Khetrapal P, Dickinson L, Punwani S, Brew-Graves C, Freeman A, Emberton M, Moore CM, Allen C, Kasivisvanathan V; PRIME Quality Improvement Group. Global Variation in Magnetic Resonance Imaging Quality of the Prostate. Radiology. 2023 Oct;309(1):e231130. doi: 10.1148/radiol.231130. PMID 37815448
- DERIVEDAsif A, Nathan A, Ng A, Khetrapal P, Chan VW, Giganti F, Allen C, Freeman A, Punwani S, Lorgelly P, Clarke CS, Brew-Graves C, Muirhead N, Emberton M, Agarwal R, Takwoingi Y, Deeks JJ, Moore CM, Kasivisvanathan V; PRIME Trial Group. Comparing biparametric to multiparametric MRI in the diagnosis of clinically significant prostate cancer in biopsy-naive men (PRIME): a prospective, international, multicentre, non-inferiority within-patient, diagnostic yield trial protocol. BMJ Open. 2023 Apr 5;13(4):e070280. doi: 10.1136/bmjopen-2022-070280. PMID 37019486
- DERIVEDNg A, Khetrapal P, Kasivisvanathan V. Is It PRIME Time for Biparametric Magnetic Resonance Imaging in Prostate Cancer Diagnosis? Eur Urol. 2022 Jul;82(1):1-2. doi: 10.1016/j.eururo.2022.02.021. Epub 2022 Mar 8.