Evidence map›Paper›PMID 34593984›Full record

SynthesisProstate cancer and prostatic diseases2022

Predicting high-grade prostate cancer at initial biopsy: clinical performance of the ExoDx (EPI) Prostate Intelliscore test in three independent prospective studies.

Erik Margolis, Gordon Brown, Alan Partin, Ballentine Carter, James McKiernan, Ronald Tutrone, Phillipp Torkler, Christian Fischer, Vasisht Tadigotla, Mikkel Noerholm and 2 more

Open access · hybridAbstract readMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Prostate cancer and prostatic diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 77 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
77citing papers in PubMed, 2 pooled it
9.0field-weighted citation impact, top 2% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

77 citing papers in PubMed, 2 syntheses or guidelines pooled it, 89 citations in OpenAlex.

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17 more citing papers are in PubMed but not listed here.

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

12 authors at 7 institutions in 1 country.

Erik MargolisUrology Center of Englewood, Englewood, NJ, USA.
Gordon BrownDelaware Valley Urology, Vorhees, NJ, USA.
Alan PartinJohns Hopkins Hospital, Baltimore, MD, USA.
Ballentine CarterJohns Hopkins Hospital, Baltimore, MD, USA.
James McKiernanColumbia University Medical Center, New York, NY, USA.
Ronald TutroneChesapeake Urology Associate, Baltimore, MD, USA.
Phillipp TorklerExosome Diagnostics, a Bio-techne brand, Martinsried, Germany.
Christian FischerExosome Diagnostics, a Bio-techne brand, Martinsried, Germany.
Vasisht TadigotlaExosome Diagnostics, a Bio-techne brand, Waltham, MA, USA.
Mikkel NoerholmExosome Diagnostics, a Bio-techne brand, Martinsried, Germany.
Michael J DonovanUniversity of Miami, Miami, Florida, USA. michael.donovan@mssm.edu.ORCID http://orcid.org/0000-0003-0772-598X
Johan SkogExosome Diagnostics, a Bio-techne brand, Waltham, MA, USA.
Exosome Diagnostics (United States) · USJohns Hopkins Hospital · USChesapeake Urology Associates · USColumbia University Irving Medical Center · USEnglewood Hospital and Medical Center · USNew Jersey Urology · USUniversity of Miami · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe ability to discriminate indolent from clinically significant prostate cancer (PC) at the initial biopsy remains a challenge. The ExoDx Prostate (IntelliScore) (EPI) test is a noninvasive liquid biopsy that quantifies three RNA targets in urine exosomes. The EPI test stratifies patients for risk of high-grade prostate cancer (HGPC; ≥ Grade Group 2 [GG] PC) in men ≥ 50 years with equivocal prostate-specific antigen (PSA) (2-10 ng/mL). Here, we present a pooled meta-analysis from three independent prospective-validation studies in men presenting for initial biopsy decision.

methodsPooled data from two prospective multi-site validation studies and the control arm of a clinical utility study were analyzed. Performance was evaluated using the area under the receiver-operating characteristic curve (AUC), negative predictive value (NPV), positive predictive value (PPV), sensitivity, and specificity for discriminating ≥ GG2 from GG1 and benign pathology.

resultsThe combined cohort (n = 1212) of initial-biopsy subjects had a median age of 63 years and median PSA of 5.2 ng/mL. The EPI AUC (0.70) was superior to PSA (0.56), Prostate Cancer Prevention Trial Risk Calculator (PCPT-RC) (0.62), and The European Randomized Study of Screening for Prostate Cancer (ERSPC) (0.59), (all p-values <0.001) for discriminating GG2 from GG1 and benign histology. The validated cutoff of 15.6 would avoid 23% of all prostate biopsies and 30% of "unnecessary" (benign or Gleason 6/GG1) biopsies, with an NPV of 90%.

conclusionsEPI is a noninvasive, easy-to-use, urine exosome-RNA assay that has been validated across 3 independent prospective multicenter clinical trials with 1212 subjects. The test can discriminate high-grade (≥GG2) from low-grade (GG1) cancer and benign disease. EPI effectively guides the biopsy-decision process independent of PSA and other standard-of-care factors.

Indexed as

ProstateProstatic NeoplasmsBiopsyHumansMaleMiddle AgedMulticenter Studies as TopicProspective StudiesProstate-Specific AntigenRisk AssessmentRNAProstate-Specific AntigenRNA

Identifiers

PMID34593984
PMCPMC9184274
OpenAlexW3203482961

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.