Abstract

Background: Widespread use of prostate specific antigen (PSA) in screening procedures allowed early identification of an increasing number of prostate cancers (PCas), mainly including indolent cancer. Availability of different therapeutic strategies which have a very different impact on the patient’s quality of life suggested a strong need for tools able to identify clinically significant cancer at diagnosis. Multi-parametric magnetic resonance showed very good performance in pre-biopsy diagnosis. However, it is an expensive tool and requires an experienced radiologist. In this context, a simple blood-based test is worth investigating. In this context, researchers focused their attention on the development of a laboratory test able to minimize overdiagnosis without losing the identification of aggressive tumors. Results: Recent literature data on PCa biomarkers revealed a clear tendency towards the use of panels of biomarkers or a combination of biomarkers and clinical variables. Phi, the 4Kscore, and Stockholm3 as circulating biomarkers and the Mi-prostate score, Exo DX Prostate, and Select MD-X as urinary biomarker-based tests have been developed. In this scenario, phi is worthy of attention as a noninvasive test significantly associated with aggressive PCa. Conclusions: Literature data showed that phi had good diagnostic performance to identify clinically significant (cs) PCa, suggesting that it could be a useful tool for personalized treatment decision-making. In this review, phi potentialities, limitations, and comparisons with other blood- and urinary-based tests were explored.

Highlights

  • Widespread use of prostate specific antigen (PSA) in screening procedures allowed early identification of an increasing number of prostate cancers (PCas), mainly including indolent cancer

  • In a prospective study on 251 subjects at first biopsy, we demonstrated that phi outperformed PSA and the free PSA (fPSA)/tPSA ratio in terms of the ability to predict positive biopsy [18]

  • The authors evaluated phi for the detection of high-grade (Gs ≥ 7) PCa and reported a high diagnostic accuracy. These findings suggested that, if routinely used, phi would reduce the rate of unnecessary biopsies, without missing aggressive PCa

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Summary

Introduction

Widespread use of prostate specific antigen (PSA) in screening procedures allowed early identification of an increasing number of prostate cancers (PCas), mainly including indolent cancer. The 4Kscore, and Stockholm as circulating biomarkers and the Mi-prostate score, Exo DX Prostate, and Select MD-X as urinary biomarker-based tests have been developed In this scenario, phi is worthy of attention as a noninvasive test significantly associated with aggressive PCa. Conclusions: Literature data showed that phi had good diagnostic performance to identify clinically significant (cs) PCa, suggesting that it could be a useful tool for personalized treatment decision-making. Martin’s Press), talking about public health disasters and highlighting the two main limits of PSA: it is not cancer-specific and it does not distinguish indolent and aggressive cancer [1] The latter is an essential criterion for a biomarker in the clinical scenario of PCa, characterized by a marked variability of disease behavior and by the diversity of available treatment and related impairment of quality of life. Researchers’ attention focused on the development of a laboratory test able to minimize overdiagnosis without missing the target in order to provide clinicians information useful to choose the best treatment for each patient: the one that matches tumor aggressiveness and therapy invasiveness [2]

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