Evidence map›Paper›PMID 41998222›Full record

ArticleNPJ digital medicine2026

Predicting clinically significant prostate cancer with or without digital rectal exam and MRI data using ClarityDX Prostate models.

Robert J Paproski, Adam Kinnaird, M Eric Hyndman, Adrian Fairey, Leonard Marks, Christian P Pavlovich, Sean A Fletcher, Roman Zachoval, Vanda Adamcova, Jiri Stejskal and 6 more

Registry-linked trialAbstract read
In one paragraph

Article in NPJ digital medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03957252 (Clinical Validation of ClarityDX Prostate as a Reflex Test to Prostate Specific Antigen), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT03957252 active not recruitingnot on this map

Clinical Validation of ClarityDX Prostate as a Reflex Test to Prostate Specific Antigen (PSA) to Refine the Prediction of Clinically-significant Prostate Cancer

TypeobservationalSponsorNanosticsRan2019 to 2027Enrolled2,800ConditionsProstate Cancer, Prostate Cancer Screening, Performance Assessment of Novel Test
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Robert J PaproskiNanostics Inc., Edmonton, AB, Canada.
Adam KinnairdDivision of Urology, Department of Surgery, University of Alberta, Kipnes Urology Centre, Edmonton, AB, Canada.
M Eric HyndmanNanostics Inc., Edmonton, AB, Canada.
Adrian FaireyNanostics Inc., Edmonton, AB, Canada.
Leonard MarksUCLA Health, Los Angeles, CA, USA.
Christian P PavlovichJames Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Sean A FletcherJames Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Roman ZachovalDepartment of Urology, 3rd Faculty of Medicine of Charles University and Thomayer University Hospital, Prague, Czech Republic.
Vanda AdamcovaDepartment of Urology, 3rd Faculty of Medicine of Charles University and Thomayer University Hospital, Prague, Czech Republic.
Jiri StejskalDepartment of Urology, 3rd Faculty of Medicine of Charles University and Thomayer University Hospital, Prague, Czech Republic.
Armen AprikianNanostics Inc., Edmonton, AB, Canada.
Christopher J D WallisDivision of Urology, Department of Surgery, University of Toronto, Toronto, ON, Canada.
Desmond PinkNanostics Inc., Edmonton, AB, Canada.
Catalina VasquezNanostics Inc., Edmonton, AB, Canada.
Perrin H BeattyNanostics Inc., Edmonton, AB, Canada.
John D LewisNanostics Inc., Edmonton, AB, Canada. jdlewis@ualberta.ca.

Funding

Alberta Innovates -ASBIRI Program G2017000328Bird Dogs - Alberta Cancer Foundation: Prostate Cancer Research Plan ACF 26001Prostate Cancer Canada PCC MTA TAG2014-03
6 · The paper itself

Abstract

This prognostic study created optimized ensembles of calibrated random forest models to predict clinically significant prostate cancer (csPCa, grade group ≥2 PCa) using total prostate-specific antigen (PSA), free PSA, negative biopsy status, and age, with or without DRE and MRI data. Observational data were aggregated from cohorts in six organizations in Canada, the USA, and Czechia. Prostate biopsies were performed between 2009 and 2024. Risk models (ClarityDX Prostate + DRE, ClarityDX Prostate + MRI, and ClarityDX Prostate + MRI + DRE) were derived (training cohorts n = 1626 to 2191) and validated (validation cohorts n = 378 to 1318) from different clinical sites. The models had ROC AUC values ≥ 0.80. Adding DRE improved the ROC AUC to 0.82 while models using MRI features had ROC AUC values of 0.87 (without DRE) and 0.88 (with DRE) in the validation cohort. These four ClarityDX Prostate models offer high accuracy in predicting csPCa in individuals in variable clinical settings.

Identifiers

PMID41998222
PMCPMC13273144

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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.