Second Reply to Letter to the Editor re: “Clinical utility of the Prostate Health Index (phi) for biopsy decision management in a large group urology practice setting”

White, J William; Tutrone, Ronald; Reynolds, Mark A.

doi:10.1038/s41391-019-0166-x

Cited by 3 publications

(2 citation statements)

References 5 publications

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“…Both tests were tested on multiethnic groups and showed high diagnostic value in them. Although both biomarkers provide similar diagnostic accuracy in the detection of general and high-grade PCa and reduce the number of unnecessary biopsies, it should be borne in mind that there are disturbing reports on PHI [80][81][82]. Furthermore, PHI should not be interpreted as absolute proof of the presence or absence of prostate cancer.…”

Section: Discussionmentioning

confidence: 99%

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Prostate Cancer Liquid Biopsy Biomarkers’ Clinical Utility in Diagnosis and Prognosis

Matuszczak

Schalken

Salagierski

2021

Cancers

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Prostate cancer (PCa) is the most common cancer in men worldwide. The current gold standard for diagnosing PCa relies on a transrectal ultrasound-guided systematic core needle biopsy indicated after detection changes in a digital rectal examination (DRE) and elevated prostate-specific antigen (PSA) level in the blood serum. PSA is a marker produced by prostate cells, not just cancer cells. Therefore, an elevated PSA level may be associated with other symptoms such as benign prostatic hyperplasia or inflammation of the prostate gland. Due to this marker’s low specificity, a common problem is overdiagnosis, which leads to unnecessary biopsies and overtreatment. This is associated with various treatment complications (such as bleeding or infection) and generates unnecessary costs. Therefore, there is no doubt that the improvement of the current procedure by applying effective, sensitive and specific markers is an urgent need. Several non-invasive, cost-effective, high-accuracy liquid biopsy diagnostic biomarkers such as Progensa PCA3, MyProstateScore ExoDx, SelectMDx, PHI, 4K, Stockholm3 and ConfirmMDx have been developed in recent years. This article compares current knowledge about them and their potential application in clinical practice.

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Section: Discussionmentioning

confidence: 99%

“…They cite NCCN and AUA recommendations that men without biopsy who are in the diagnostic grey area will be monitored more closely or with additional methods. In a second response [82], it was shown that due to the small number of highgrade cancers, the study would not allow drawing firm conclusions.…”

Section: Prostate Health Index (Phi)mentioning

confidence: 97%

Prostate Cancer Liquid Biopsy Biomarkers’ Clinical Utility in Diagnosis and Prognosis

Matuszczak

Schalken

Salagierski

2021

Cancers

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Established and emerging liquid biomarkers for prostate cancer detection: A review

Olson,

Wagner

2025

Urologic Oncology: Seminars and Original Investigations

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Biomarker Evaluation and Clinical Development

Assel¹

2020

Société Internationale D’Urologie Journal

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Most candidate biomarkers are never adopted into clinical practice. The likelihood that a biomarker with good predictive properties will be incorporated into urologic decision-making and will improve patient care can be enhanced by following established principles of biomarker development. Studies should follow the REMARK guidelines, should have clinically relevant outcomes, and should evaluate the biomarker on the same patients to whom the biomarker would be applied in practice. It is also important to recognize that biomarker research is comparative: the question is not whether a biomarker provides information, but whether it provides better information than is already available. Continuous biomarkers should not be categorized above or below a fixed cutpoint: risk prediction allows for individualization of care. The risk predictions must be calibrated, that is, close to a patient’s true risk, and decision analysis is required to determine whether using the biomarker in clinical practice would change decisions and improve outcomes. Finally, impact studies are needed to evaluate how use of the biomarker in the real world affects outcomes.

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Second Reply to Letter to the Editor re: “Clinical utility of the Prostate Health Index (phi) for biopsy decision management in a large group urology practice setting”

Cited by 3 publications

References 5 publications

Prostate Cancer Liquid Biopsy Biomarkers’ Clinical Utility in Diagnosis and Prognosis

Prostate Cancer Liquid Biopsy Biomarkers’ Clinical Utility in Diagnosis and Prognosis

Established and emerging liquid biomarkers for prostate cancer detection: A review

Biomarker Evaluation and Clinical Development

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