Trial reportProstate cancer and prostatic diseases2020
Clinical utility of the exosome based ExoDx Prostate(IntelliScore) EPI test in men presenting for initial Biopsy with a PSA 2-10 ng/mL.
Trial report in Prostate cancer and prostatic diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03235687 (A Prospective, Randomized Blinded, Shared Decision Impact Trial of the ExoDx Prostate), which is not on this map. Cited by 99 papers.
What it found
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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.
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.
A Prospective, Randomized Blinded, Shared Decision Impact Trial of the ExoDx Prostate (IntelliScore), EPI Test, in Men Presenting for Initial Biopsy.
Who cites it
99 citing papers in PubMed, 164 citations in OpenAlex.
- ExoDx prostate test as a predictor of outcomes of high-grade prostate cancer - an interim analysis.Prostate cancer and prostatic diseases · 2023Trial
- Recent advances in discriminating prostate cancer from benign prostatic diseases in the pre-biopsy population.Medical oncology (Northwood, London, England) · 2026Review
- Urinary Biomarkers in Urological Oncology: From Biological Origin to Clinical Decision-Making-A Narrative Review.Diagnostics (Basel, Switzerland) · 2026Review
- Comparing diagnostic prostate cancer biomarkers using a framework of clinically meaningful criteria.BJUI compass · 2026Article
- Evolving role of biomarkers beyond prostate‑specific antigen in refining prostate cancer screening: From blood‑based tests to urinary and genetic markers (Review).Molecular medicine reports · 2026Review
- Circulating Tumor Function: A Systems Biology Framework for Liquid Biopsy in Genitourinary Cancers.Genes · 2026Review
- Early-Onset Prostate Cancer: Epidemiology, Risk Factors, Biology, Clinical Features, Management, and Early Detection.MedComm · 2026Review
- Extracellular vesicles in solid tumors: from tumor ecology to engineered therapeutics.Molecular cancer · 2026Review
- Review
- Extracellular vesicles in prostate cancer: current understanding and future perspectives.Journal of the National Cancer Center · 2026Review
- A rapid urinary test for combining PSA and zinc to enhance prostate cancer diagnosis: results from a prospective study.Prostate cancer and prostatic diseases · 2026Article
- The updated role of exosomes in cancer diagnosis and therapy.Discover oncology · 2026Review
- Prostate Cancer Biomarkers with a Focus on Galectin-3: Emerging Clinical and Therapeutic Implications.Current oncology (Toronto, Ont.) · 2026Review
- Early-stage multi-cancer detection through a plasma extracellular vesicle protein signature.Cell reports. Medicine · 2026Article
- From prostate specific antigen to genomic signatures: Advances in biomarkers for prostate cancer diagnosis and prognosis.Translational oncology · 2026Review
- Computational frameworks for enhanced extracellular vesicle biomarker discovery.Experimental & molecular medicine · 2026Review
- Unlocking the power of extracellular vesicles: multi-omics integration for cancer biomarker discovery.Biomarker research · 2026Review
- Engineering Small Extracellular Vesicles for Colon-Targeted Delivery: Microenvironment-Responsive Design, Therapeutic Mechanisms, and Clinical Translation.International journal of nanomedicine · 2026Review
- Extracellular Vesicles and the Gartner Hype Cycle.Journal of extracellular biology · 2025Article
- Tumor Extracellular Vesicle Digital Scoring Assays for Cancer Detection and Monitoring.Precision chemistry · 2025Review
39 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe ExoDx Prostate(IntelliScore) (EPI) test is a non-invasive risk assessment tool for detection of high-grade prostate cancer (HGPC) that informs whether to proceed with prostate biopsy. We sought to assess the impact of EPI on the decision to biopsy in a real-world clinical setting.
methodsWe conducted a prospective, randomized, blinded, two-armed clinical utility study that enrolled 1094 patients with 72 urologists from 24 urology practices. Patients were considered for prostate biopsy at enrollment based on standard clinical criteria. All patients had an EPI test; however, patients were randomized into EPI vs. control arms where only the EPI arm received results for their biopsy decision.
resultsIn the EPI arm (N = 458), 93 patients received negative EPI scores of which 63% were recommended to defer biopsy by the urologist and 74% ultimately deferred. In contrast, 87% of patients with positive EPI scores were recommended to undergo biopsy with a 72% compliance rate to the urologist's recommendation. This led to detection of 30% more HGPC compared to the control arm, and we estimate that 49% fewer HGPC were missed due to deferrals compared to standard of care (SOC). Overall, 68% of urologists reported that the EPI test influenced their biopsy decision. The primary reason not to comply with EPI results was rising PSA.
conclusionTo our knowledge this is the first report on a PC biomarker utility study with a blinded control arm. The study demonstrates that the EPI test influences the overall decision to defer or proceed with a biopsy and improves patient stratification.
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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.