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@ARTICLE{Ng:304499,
author = {A. B. C. D. Ng and A. Asif and R. Agarwal and V. Panebianco
and R. Girometti and S. Ghai and E. Gómez-Gómez and L.
Budäus and T. Barrett and J. P. Radtke$^*$ and C. Kesch$^*$
and F. De Cobelli and T. Pham and S. S. Taneja and J. C. Hu
and A. Tewari and M. Á. Rodríguez Cabello and A. B. Dias
and L. A. Mynderse and M. Borghi and L. Boesen and P. Singh
and R. Renard-Penna and J. J. Leow and F. Falkenbach and M.
Pecoraro and G. Giannarini and N. Perlis and D. López-Ruiz
and C. Kastner and L. Schimmöller and M. Rossiter and A.
Nathan and P. Khetrapal and V. W. Chan and A. Haider and C.
S. Clarke and S. Punwani and C. Brew-Graves and L. Dickinson
and A. Mitra and G. Brembilla and D. J. A. Margolis and Y.
Takwoingi and M. Emberton and C. Allen and F. Giganti and C.
M. Moore and V. Kasivisvanathan},
collaboration = {PRIME Study {Group Collaborators}},
othercontributors = {A. Borrelli and A. Briganti and A. Crestani and A. Sciarra
and A. Evangelista and A. Freeman and A. Kirkham and A.
Zlotta and A. Blanca Pedregosa and A. Bjartell and A. Ryan
and A. Tong and A. Warren and A. Andrews and A. Finelli and
A. Ciardi and A. Rannikko and A. Stabile and A. Villers and
A. Platas Sancho and A. Baring and A. Roy and B. Issa and B.
Israël and B. A. Hadaschik and C. Aulló Gonzalez and C. L.
English and C. Hung Lee and C. Zuiani and C. Caris and C.
Von Stempel and C. Amate and D. Z. Yong and D. Rozze and D.
J. Lomas and D. Cannoletta and E. Wang Chang and E. Messina
and G. Zussino and G. Antoch and G. Gandaglia and G. Robert
and G. Sauter and H. Thevarajah and H. Sorrell and H. McBain
and H. Reis and H. Rios Pita and I. Potyka and I. Caglic and
J. Collavino and J. Theysohn and J. Grummet and J. Koshy and
J. Y. J. Weng and J. Wilkinson and J. van Egmond and J.
Piper and J. Deeks and J. O'Brien and J. Valero Rosa and J.
Luis Sanz Miguelañez and J. Mesa Quesada and K. Jannusch
and K. Corr and K. Haines and L. Umutlu and L. Quarta and L.
Casarotto and L. Gimeno and L. Orecchia and L. Moretti and
L. Laschena and L. Drewes and M. de Rooij and M. Sanchez
Ostos and M. Bicchetti and M. Gatti and M. de Los
Desamparados Esteban Peris and M. Volpacchio and M. Prentice
and M. Graefen and M. Soligo and M. Boschheidgen and M. C.
Roethke and M. Del Monte and M. Singhera and M. Fatterpekar
and M. Al-Nader and M. Kachanov and N. Shaida and N.
Takahashi and N. Fleshner and N. Muirhead and N. Vasdev and
N. Sanmugalingam and N. Nørgaard and P. Albers and P.
Vicente and P. Incze and P. Ryan and P. Rouvier and P. Mead
and P. Charles Mozer and P. De Visschere and P. C. C. Viana
and R. E. Jimenez and R. Novotta and R. Huang and R.
O'Sullivan and R. Karlin Jepsen and R. Frese and R. Clow and
R. Al-Monajjed and S. Lewis and S. Cashman and S. Pizzolitto
and S. Lelie and S. Lindner and S. Shah and T. Al-Hammouri
and T. González Sanchez and T. Bathala and T. H. van der
Kwast and T. Reid and T. McClure and T. Maurer and V.
Peruzzi and V. Løgager and V. Prabhu and V. Wagaskar and W.
Witjes},
title = {{B}iparametric vs {M}ultiparametric {MRI} for {P}rostate
{C}ancer {D}iagnosis: {T}he {PRIME} {D}iagnostic {C}linical
{T}rial.},
journal = {The journal of the American Medical Association},
volume = {nn},
issn = {0254-9077},
address = {Chicago, Ill.},
publisher = {American Medical Association},
reportid = {DKFZ-2025-01888},
pages = {nn},
year = {2025},
note = {epub},
abstract = {Multiparametric magnetic resonance imaging (MRI), with or
without prostate biopsy, has become the standard of care for
diagnosing clinically significant prostate cancer. Resource
capacity limits widespread adoption. Biparametric MRI, which
omits the gadolinium contrast sequence, is a shorter and
cheaper alternative offering time-saving capacity gains for
health systems globally.To assess whether biparametric MRI
is noninferior to multiparametric MRI for diagnosis of
clinically significant prostate cancer.A prospective,
multicenter, within-patient, noninferiority trial of
biopsy-naive men from 22 centers (12 countries) with
clinical suspicion of prostate cancer (elevated
prostate-specific antigen [PSA] level and/or abnormal
digital rectal examination findings) from April 2022 to
September 2023, with the last follow-up conducted on
December 3, 2024.Participants underwent multiparametric MRI,
comprising T2-weighted, diffusion-weighted, and dynamic
contrast-enhanced (DCE) sequences. Radiologists reported
abbreviated biparametric MRI first (T2-weighted and
diffusion-weighted), blinded to the DCE sequence. After
unblinding, radiologists reported the full multiparametric
MRI. Patients underwent a targeted biopsy with or without
systematic biopsy if either biparametric MRI or
multiparametric MRI was suggestive of clinically significant
prostate cancer.The primary outcome was the proportion of
men with clinically significant prostate cancer. Secondary
outcomes included the proportion of men with clinically
insignificant cancer. The noninferiority margin was $5\%.Of$
555 men recruited, 490 were included for primary outcome
analysis. Median age was 65 (IQR, 59-70) years and median
PSA level was 5.6 (IQR, 4.4-8.0) ng/mL. The proportion of
patients with abnormal digital rectal examination findings
was $12.7\%.$ Biparametric MRI was noninferior to
multiparametric MRI, detecting clinically significant
prostate cancer in 143 of 490 men $(29.2\%),$ compared with
145 of 490 men $(29.6\%)$ (difference, -0.4 $[95\%$ CI, -1.2
to 0.4] percentage points; P = .50). Biparametric MRI
detected clinically insignificant cancer in 45 of 490 men
$(9.2\%),$ compared with 47 of 490 men $(9.6\%)$ with the
use of multiparametric MRI (difference, -0.4 $[95\%$ CI,
-1.2 to 0.4] percentage points). Central quality control
demonstrated that $99\%$ of scans were of adequate
diagnostic quality.In men with suspected prostate cancer,
provided image quality is adequate, an abbreviated
biparametric MRI scan, with or without targeted biopsy,
could become the new standard of care for prostate cancer
diagnosis. With approximately 4 million prostate MRIs
performed globally annually, adopting biparametric MRI could
substantially increase scanner throughput and reduce costs
worldwide.ClinicalTrials.gov Identifier: NCT04571840.},
cin = {E010 / ED01},
ddc = {610},
cid = {I:(DE-He78)E010-20160331 / I:(DE-He78)ED01-20160331},
pnm = {315 - Bildgebung und Radioonkologie (POF4-315)},
pid = {G:(DE-HGF)POF4-315},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:40928788},
doi = {10.1001/jama.2025.13722},
url = {https://inrepo02.dkfz.de/record/304499},
}
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