Prostate CancerPRIMENCT04571840
Prostate Imaging Using MRI +/- Contrast Enhancement
A study testing Multiparametric MRI +/- prostate biopsy and Biparametric MRI +/- prostate biopsy in people with Prostate Cancer, run by University College, London at 31 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Multiparametric MRI +/- prostate biopsy and Biparametric MRI +/- prostate biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 31 sitesin 15 countries
- Study dates
- 22 Mar 2022to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men at least 18 years of age referred with clinical suspicion of prostate cancer
- Serum PSA ≤ 20ng/ml
- Fit to undergo all procedures listed in protocol
- Able to provide written informed consent
Who cannot join
- Prior prostate biopsy
- Prior treatment for prostate cancer
- Prior prostate MRI on a previous encounter
- Contraindication to MRI
- Contraindication to prostate biopsy
- Unfit to undergo any procedures listed in protocol
Trial locations and contacts
31 sites in 15 countries.
31 sites in 15 countries
United States4 sites
NYU Langone
New York, New York, 10016
Icahn School of Medicine (Mount Sinai)
New York, New York, 10029
New York Presbyterian Hospital
New York, New York, 10032
Mayo Clinic
Rochester, Minnesota, 55905
Germany4 sites
Heinrich Heine University Düsseldorf
Düsseldorf
Essen University Hospital
Essen
University Hospital Frankfurt
Frankfurt
Martini Klinik
Hamburg
Italy4 sites
San Raffaele Hospital
Milan
Sapienza University
Rome
San Giovanni Battista Hospital
Turin
University Hospital of Udine
Udine
United Kingdom4 sites
Addenbrooke's Hospital
Cambridge
Royal Free London NHS Foundation Trust
London
University College London and University College London Hospital
London
Whittington Hospital
London
France3 sites
Bordeaux Pellegrin University Hospital
Bordeaux
CHU Lille
Lille
Sorbonne Université
Paris
Australia2 sites
Monash University
Melbourne
Peter MacCallum Cancer Centre
Melbourne E.
Spain2 sites
Hospital Universitario Reina Sofía
Córdoba
Hospital Universitario La Moraleja
Madrid
About this study
Official title: A Study Comparing Bi-parametric MRI to Multi-parametric MRI in the Diagnosis of Clinically Significant Prostate Cancer
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.
Read the 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:
- - Very low (clinically significant cancer is highly unlikely to be present)
- - Low (clinically significant cancer is unlikely to be present)
- - Intermediate (the presence of clinically significant cancer is equivocal)
- - High (clinically significant cancer is likely to be present)
- - 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.
- Conditions
- Prostate Cancer
- Being tested
- Multiparametric MRI +/- prostate biopsy, Biparametric MRI +/- prostate biopsy
- Keywords
- mri, biopsy, targeted, diagnosis, multiparametric, biparametric
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiparametric MRI +/- prostate biopsyDiagnostic test
MRI with T2-weighted, diffusion weighted and dynamic contrast enhanced sequences followed by prostate biopsy if indicated on MRI and clinical findings
Biparametric MRI +/- prostate biopsyDiagnostic test
MRI with T2-weighted and diffusion weighted sequences followed by prostate biopsy if indicated on MRI and clinical findings
| Study group | Role | What they receive |
|---|---|---|
| mpMRI | Active comparator | Multiparametric MRI Receives: Diagnostic Test: Multiparametric MRI +/- prostate biopsy |
| bpMRI | Experimental | Biparametric MRI Receives: Diagnostic Test: Biparametric MRI +/- prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of men with clinically significant cancer
Measured: When biopsy results available, at an expected average of 30 days post-biopsy
Secondary outcomes (7)
Proportion of men with clinically insignificant cancer (Gleason grade 3+3 / Gleason grade group 1)
Measured: When biopsy results available, at an expected average of 30 days post-biopsy
Agreement between bpMRI and mpMRI for score of suspicion
Score of suspicion on MRI (1-5) - lowest score = 1 = highly unlikely to be significant cancer. Highest score = 5 = highly likely to be significant cancer. For MRI to be non-suspicious it needs to be scored 1 or 2 on both Likert and PIRADSv2.1 systems. For MRI to be suspicious it can to be scored 3, 4 or 5 on either Likert or PIRADSv2.1 systems.
Measured: When MRI results available, at an expected average of 30 days post-MRI
Agreement between bpMRI and mpMRI for radiological staging decision
Measured: When MRI results available, at an expected average of 30 days post-MRI
Agreement between bpMRI and mpMRI for treatment eligibility
At the coordinating centre, in a multi-disciplinary team meeting, 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.
Measured: When treatment options discussed in multidisciplinary meeting, at an expected average of 30 days post intervention
Test performance characteristics for bpMRI & mpMRI when using the Likert scoring system in comparison to the PIRADS scoring system
Measured: When biopsy results available, at an expected average of 30 days post-MRI
Proportion of men with cancer missed by bpMRI and mpMRI-targeted biopsies and detected by systematic biopsy
Measured: When biopsy results available, at an expected average of 30 days post-biopsy
Cost-effectiveness of BpMRI compared to mpMRI (cost per diagnosis of prostate cancer)
A within-trial analysis will be conducted to calculate the total cost for bpMRI and mpMRI and mean cost per patient if a strategy of bpMRI or mpMRI were adopted. The cost per diagnosis of clinically significant cancer will be calculated for bpMRI and mpMRI. An incremental cost effectiveness ratio may be calculated by deriving the additional cost per case of clinically significant cancer diagnosed. The cost of avoiding each additional case of clinically insignificant cancer diagnosed may also be calculated. Consideration will be given to extending this analysis using economic modelling to allow a lifetime perspective to be taken and the estimation of quality adjusted life years (QALYs). Costs of procedures will be estimated by multiplying standard unit costs by key resource using data captured within the trial. If possible, standard unit costs (e.g. NHS Reference costs) will be supplemented by unit cost data (and uncertainty around these costs) from the participating trial sites.
Measured: At an expected average of 30 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start22 Mar 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Within-person controlled, paired cohort, diagnostic evaluation study. Participants undergo two index tests and a reference test.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veeru Kasivisvanathan, MBBS PhD, Study chair, University College, LondonCaroline Moore, MD FRCS, Principal investigator, University College, LondonMark Emberton, MD FRCS, Principal investigator, University College, LondonClare Allen, FRCR, Principal investigator, University College London HospitalsShonit Punwani, PhD FRCR, Principal investigator, University College, LondonFrancesco Giganti, MD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571840
- Sponsor's protocol ID
- 135819
- Acronym
- PRIME
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2020
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Anonymised data will be available at request for bona fide researchers with important research questions subject to approval by the study steering committee.
Publications
Micheleto 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.
PubMed 41989063Ng 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.
PubMed 40928788Giganti 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.
PubMed 37815448Asif 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.
PubMed 37019486Ng 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.
PubMed 35277288
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing Bi-parametric MRI to Multi-parametric MRI in the Diagnosis of Clinically Significant Prostate Cancer
- ClinicalTrials.gov ID
- NCT04571840
- Acronym / sponsor ID
- PRIME / 135819
- Conditions
- Prostate Cancer
- Keywords
- mri, biopsy, targeted, diagnosis, multiparametric, biparametric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- - Very low (clinically significant cancer is highly unlikely to be present)
- - Low (clinically significant cancer is unlikely to be present)
- - Intermediate (the presence of clinically significant cancer is equivocal)
- - High (clinically significant cancer is likely to be present)
- - 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Within-person controlled, paired cohort, diagnostic evaluation study. Participants undergo two index tests and a reference test.
| Arm | Type | Receives |
|---|---|---|
| mpMRI | Active comparator | Diagnostic Test: Multiparametric MRI +/- prostate biopsyMultiparametric MRI |
| bpMRI | Experimental | Diagnostic Test: Biparametric MRI +/- prostate biopsyBiparametric MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men at least 18 years of age referred with clinical suspicion of prostate cancer
- Serum PSA ≤ 20ng/ml
- Fit to undergo all procedures listed in protocol
- Able to provide written informed consent
Key exclusion criteria (6 listed)
- Prior prostate biopsy
- Prior treatment for prostate cancer
- Prior prostate MRI on a previous encounter
- Contraindication to MRI
- Contraindication to prostate biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiparametric MRI +/- prostate biopsyMRI with T2-weighted, diffusion weighted and dynamic contrast enhanced sequences followed by prostate biopsy if indicated on MRI and clinical findings | Diagnostic test | mpMRI |
| Biparametric MRI +/- prostate biopsyMRI with T2-weighted and diffusion weighted sequences followed by prostate biopsy if indicated on MRI and clinical findings | Diagnostic test | bpMRI |
Primary outcome
Proportion of men with clinically significant cancer
Time frame: When biopsy results available, at an expected average of 30 days post-biopsy
7 secondary outcomes
Proportion of men with clinically insignificant cancer (Gleason grade 3+3 / Gleason grade group 1)
Time frame: When biopsy results available, at an expected average of 30 days post-biopsy
Agreement between bpMRI and mpMRI for score of suspicion
Time frame: When MRI results available, at an expected average of 30 days post-MRI
Agreement between bpMRI and mpMRI for radiological staging decision
Time frame: When MRI results available, at an expected average of 30 days post-MRI
Agreement between bpMRI and mpMRI for treatment eligibility
Time frame: When treatment options discussed in multidisciplinary meeting, at an expected average of 30 days post intervention
Test performance characteristics for bpMRI & mpMRI when using the Likert scoring system in comparison to the PIRADS scoring system
Time frame: When biopsy results available, at an expected average of 30 days post-MRI
Proportion of men with cancer missed by bpMRI and mpMRI-targeted biopsies and detected by systematic biopsy
Time frame: When biopsy results available, at an expected average of 30 days post-biopsy
Cost-effectiveness of BpMRI compared to mpMRI (cost per diagnosis of prostate cancer)
Time frame: At an expected average of 30 days post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Derived from this study: PubMed 41989063Micheleto 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.
- Derived from this study: PubMed 40928788Ng 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.
- Derived from this study: PubMed 37815448Giganti 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.
- Derived from this study: PubMed 37019486Asif 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.
- Derived from this study: PubMed 35277288Ng 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.
- Individual participant dataSharing planned: Yes. Anonymised data will be available at request for bona fide researchers with important research questions subject to approval by the study steering committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veeru Kasivisvanathan, MBBS PhD study chair
University College, London
Caroline Moore, MD FRCS principal investigator
University College, London
Mark Emberton, MD FRCS principal investigator
University College, London
31 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiparametric MRI +/- prostate biopsy and Biparametric MRI +/- prostate biopsy in people with Prostate Cancer, run by University College, London at 31 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Germany, Italy, United Kingdom, France and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of men with clinically significant cancer (time frame: When biopsy results available, at an expected average of 30 days post-biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04571840, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.