Evidence map›Paper›PMID 34237810›Full record

Trial reportThe New England journal of medicine2021

MRI-Targeted or Standard Biopsy in Prostate Cancer Screening.

Martin Eklund, Fredrik Jäderling, Andrea Discacciati, Martin Bergman, Magnus Annerstedt, Markus Aly, Axel Glaessgen, Stefan Carlsson, Henrik Grönberg, Tobias Nordström and 1 more

4 registry-linked trialsOpen access · bronzeAbstract readComparative StudyEquivalence TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 201 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
201citing papers in PubMed, 5 pooled it
38.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03377881 naactive not recruitingnot on this map

STHLM3 MR Phase 2: A New Diagnostic Chain for Prostate Cancer Detection Using the Stockholm3 Test and MR/Fusion Biopsies

TypeinterventionalSponsorKarolinska InstitutetRan2018 to 2030Enrolled12,750ConditionsProstate CancerArmsMRI/Fusion biopsies, Systematic biopsies
NCT05820113 nacompletednot on this mapstarted 2022, after this paper: background citation

Deep Learning Super Resolution Reconstruction for Fast and Motion Robust T2-weighted Prostate MRI

TypeinterventionalSponsorUniversity Hospital, BonnRan2022 to 2022Enrolled109ConditionsProstate Cancer, Multiparametric MRIArmsDeep learning based reconstruction of T2-TSE sequence
NCT06244680 completednot on this mapstarted 2023, after this paper: background citation

Super-fast 3T Prostate MRI Using High Gradient Strength and Deep Learning: Initial Experience

TypeobservationalSponsorUniversity Hospital, BonnRan2023 to 2023Enrolled77ConditionsProstate CancerArmsMRI of the prostate
NCT07398690 narecruitingnot on this mapstarted 2026, after this paper: background citation

Integrated Noninvasive Strategy Guided by Multiparametric MRI and the Prostate Health Index for Risk-Adapted Detection of Clinically Significant Prostate Cancer: A Multicenter Randomized Controlled Trial (INSIGHT-PCa Study)

TypeinterventionalSponsorIn Gab Jeong, MDRan2026 to 2029Enrolled1,432ConditionsProstate Cancer (Diagnosis), Prostate CancerArmsDiagnostic Procedure
3 · Its place in the literature

Who cites it

201 citing papers in PubMed, 5 syntheses or guidelines pooled it, 359 citations in OpenAlex.

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  5. Imaging of Prostate Cancer.Deutsches Arzteblatt international · 2021
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141 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 3 countries.

Martin EklundFrom the Departments of Medical Epidemiology and Biostatistics (M.E., A.D., M.B., H.G., T.N.) and Molecular Medicine and Surgery (F.J., M. Aly, S.C.), and the Department of Clinical Sciences at Danderyd Hospital (T.N.), Karolinska Institutet, the Department of Diagnostic Radiology (F.J.), the Department of Surgery (M.B., H.G.) and the Department of Clinical Pathology and Cytology, Unilabs (A.G.), Capio St. Göran's Hospital, C-Medical Urology Odenplan (M. Annerstedt), and the Department of Urology, Karolinska University Hospital Solna (M. Aly, S.C.) - all in Stockholm.
Fredrik JäderlingFrom the Departments of Medical Epidemiology and Biostatistics (M.E., A.D., M.B., H.G., T.N.) and Molecular Medicine and Surgery (F.J., M. Aly, S.C.), and the Department of Clinical Sciences at Danderyd Hospital (T.N.), Karolinska Institutet, the Department of Diagnostic Radiology (F.J.), the Department of Surgery (M.B., H.G.) and the Department of Clinical Pathology and Cytology, Unilabs (A.G.), Capio St. Göran's Hospital, C-Medical Urology Odenplan (M. Annerstedt), and the Department of Urology, Karolinska University Hospital Solna (M. Aly, S.C.) - all in Stockholm.
Andrea DiscacciatiFrom the Departments of Medical Epidemiology and Biostatistics (M.E., A.D., M.B., H.G., T.N.) and Molecular Medicine and Surgery (F.J., M. Aly, S.C.), and the Department of Clinical Sciences at Danderyd Hospital (T.N.), Karolinska Institutet, the Department of Diagnostic Radiology (F.J.), the Department of Surgery (M.B., H.G.) and the Department of Clinical Pathology and Cytology, Unilabs (A.G.), Capio St. Göran's Hospital, C-Medical Urology Odenplan (M. Annerstedt), and the Department of Urology, Karolinska University Hospital Solna (M. Aly, S.C.) - all in Stockholm.
Martin BergmanFrom the Departments of Medical Epidemiology and Biostatistics (M.E., A.D., M.B., H.G., T.N.) and Molecular Medicine and Surgery (F.J., M. Aly, S.C.), and the Department of Clinical Sciences at Danderyd Hospital (T.N.), Karolinska Institutet, the Department of Diagnostic Radiology (F.J.), the Department of Surgery (M.B., H.G.) and the Department of Clinical Pathology and Cytology, Unilabs (A.G.), Capio St. Göran's Hospital, C-Medical Urology Odenplan (M. Annerstedt), and the Department of Urology, Karolinska University Hospital Solna (M. Aly, S.C.) - all in Stockholm.
Magnus AnnerstedtFrom the Departments of Medical Epidemiology and Biostatistics (M.E., A.D., M.B., H.G., T.N.) and Molecular Medicine and Surgery (F.J., M. Aly, S.C.), and the Department of Clinical Sciences at Danderyd Hospital (T.N.), Karolinska Institutet, the Department of Diagnostic Radiology (F.J.), the Department of Surgery (M.B., H.G.) and the Department of Clinical Pathology and Cytology, Unilabs (A.G.), Capio St. Göran's Hospital, C-Medical Urology Odenplan (M. Annerstedt), and the Department of Urology, Karolinska University Hospital Solna (M. Aly, S.C.) - all in Stockholm.
Markus AlyFrom the Departments of Medical Epidemiology and Biostatistics (M.E., A.D., M.B., H.G., T.N.) and Molecular Medicine and Surgery (F.J., M. Aly, S.C.), and the Department of Clinical Sciences at Danderyd Hospital (T.N.), Karolinska Institutet, the Department of Diagnostic Radiology (F.J.), the Department of Surgery (M.B., H.G.) and the Department of Clinical Pathology and Cytology, Unilabs (A.G.), Capio St. Göran's Hospital, C-Medical Urology Odenplan (M. Annerstedt), and the Department of Urology, Karolinska University Hospital Solna (M. Aly, S.C.) - all in Stockholm.
Axel GlaessgenFrom the Departments of Medical Epidemiology and Biostatistics (M.E., A.D., M.B., H.G., T.N.) and Molecular Medicine and Surgery (F.J., M. Aly, S.C.), and the Department of Clinical Sciences at Danderyd Hospital (T.N.), Karolinska Institutet, the Department of Diagnostic Radiology (F.J.), the Department of Surgery (M.B., H.G.) and the Department of Clinical Pathology and Cytology, Unilabs (A.G.), Capio St. Göran's Hospital, C-Medical Urology Odenplan (M. Annerstedt), and the Department of Urology, Karolinska University Hospital Solna (M. Aly, S.C.) - all in Stockholm.
Stefan CarlssonFrom the Departments of Medical Epidemiology and Biostatistics (M.E., A.D., M.B., H.G., T.N.) and Molecular Medicine and Surgery (F.J., M. Aly, S.C.), and the Department of Clinical Sciences at Danderyd Hospital (T.N.), Karolinska Institutet, the Department of Diagnostic Radiology (F.J.), the Department of Surgery (M.B., H.G.) and the Department of Clinical Pathology and Cytology, Unilabs (A.G.), Capio St. Göran's Hospital, C-Medical Urology Odenplan (M. Annerstedt), and the Department of Urology, Karolinska University Hospital Solna (M. Aly, S.C.) - all in Stockholm.
Henrik GrönbergFrom the Departments of Medical Epidemiology and Biostatistics (M.E., A.D., M.B., H.G., T.N.) and Molecular Medicine and Surgery (F.J., M. Aly, S.C.), and the Department of Clinical Sciences at Danderyd Hospital (T.N.), Karolinska Institutet, the Department of Diagnostic Radiology (F.J.), the Department of Surgery (M.B., H.G.) and the Department of Clinical Pathology and Cytology, Unilabs (A.G.), Capio St. Göran's Hospital, C-Medical Urology Odenplan (M. Annerstedt), and the Department of Urology, Karolinska University Hospital Solna (M. Aly, S.C.) - all in Stockholm.
Tobias NordströmFrom the Departments of Medical Epidemiology and Biostatistics (M.E., A.D., M.B., H.G., T.N.) and Molecular Medicine and Surgery (F.J., M. Aly, S.C.), and the Department of Clinical Sciences at Danderyd Hospital (T.N.), Karolinska Institutet, the Department of Diagnostic Radiology (F.J.), the Department of Surgery (M.B., H.G.) and the Department of Clinical Pathology and Cytology, Unilabs (A.G.), Capio St. Göran's Hospital, C-Medical Urology Odenplan (M. Annerstedt), and the Department of Urology, Karolinska University Hospital Solna (M. Aly, S.C.) - all in Stockholm.
STHLM3 consortium
Institute of Molecular Medicine · INKarolinska University Hospital · SESaint Göran Hospital · SEUnilabs (Norway) · NO

Funding

Cancerfonden CAN 2015/649Cancerfonden CAN 2018/741Forskningsrådet om Hälsa, Arbetsliv och Välfärd 2015-00184Vetenskapsrådet 2015-03292Vetenskapsrådet 2019-01466
6 · The paper itself

Abstract

backgroundHigh rates of overdiagnosis are a critical barrier to organized prostate cancer screening. Magnetic resonance imaging (MRI) with targeted biopsy has shown the potential to address this challenge, but the implications of its use in the context of organized prostate cancer screening are unknown.

methodsWe conducted a population-based noninferiority trial of prostate cancer screening in which men 50 to 74 years of age from the general population were invited by mail to participate; participants with prostate-specific antigen (PSA) levels of 3 ng per milliliter or higher were randomly assigned, in a 2:3 ratio, to undergo a standard biopsy (standard biopsy group) or to undergo MRI, with targeted and standard biopsy if the MRI results suggested prostate cancer (experimental biopsy group). The primary outcome was the proportion of men in the intention-to-treat population in whom clinically significant cancer (Gleason score ≥7) was diagnosed. A key secondary outcome was the detection of clinically insignificant cancers (Gleason score 6).

resultsOf 12,750 men enrolled, 1532 had PSA levels of 3 ng per milliliter or higher and were randomly assigned to undergo biopsy: 603 were assigned to the standard biopsy group and 929 to the experimental biopsy group. In the intention-to-treat analysis, clinically significant cancer was diagnosed in 192 men (21%) in the experimental biopsy group, as compared with 106 men (18%) in the standard biopsy group (difference, 3 percentage points; 95% confidence interval [CI], -1 to 7; P<0.001 for noninferiority). The percentage of clinically insignificant cancers was lower in the experimental biopsy group than in the standard biopsy group (4% [41 participants] vs. 12% [73 participants]; difference, -8 percentage points; 95% CI, -11 to -5).

conclusionsMRI with targeted and standard biopsy in men with MRI results suggestive of prostate cancer was noninferior to standard biopsy for detecting clinically significant prostate cancer in a population-based screening-by-invitation trial and resulted in less detection of clinically insignificant cancer. (Funded by the Swedish Research Council and others; STHLM3-MRI ClinicalTrials.gov number, NCT03377881.).

Indexed as

Magnetic Resonance ImagingAgedBiopsyHumansIntention to Treat AnalysisMaleMiddle AgedNeoplasm GradingProstateProstate-Specific AntigenProstatic NeoplasmsProstate-Specific Antigen

Identifiers

PMID34237810
OpenAlexW3183065453

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.