An overview of current and emerging diagnostic, staging and prognostic markers for prostate cancer

ABSTRACT

Introduction

This manuscript aims to give an overview of current diagnostic, staging, and prognostic markers for prostate cancer (PCa) and discuss emerging approaches. The widespread use of PSA for early detection led to improved survival but at the cost of over-diagnosis, often associated with over-treatment and its adverse events. There is thus an unmet need for new markers to sustainably improve the diagnosis and risk assessment, thereby providing a more accurate treatment decision for each individual patient.

Areas covered

Promising new molecular serum (PSA, PHI, 4Kscore®), urine (Progensa®, SelectMDx®, MiPS) and tissue-based markers (Ki-67, Prolaris®, ConfirmMDx®, Oncotype Dx®, Decipher®, Promark®) will be discussed in this review.

Expert opinion

Over-diagnosis and difficulties in prognosticating clinical outcome among patients with similar histological and clinical parameters often lead to over- or under-treatment.

New markers will probably be used with clinical and histopathological features as well as imaging diagnostics to capture the comprehensive biology and clinical behavior of PCa.

New biomarkers open the avenue to avoid mpMRI with targeted biopsy in the future, thereby sparing risks and pitfalls associated with this approach.

Before this utopia becomes reality, the panel of technologically complementary markers need to prove that they are better, cheaper, and faster than current strategies.

KEYWORDS:

• Diagnosis
• molecular marker
• prognosis
• prostate cancer

Article highlights

• The use of numerous new biomarkers has been evaluated all along with the disease states.

• Pre-diagnostic markers have been assessed considering their ability to identify clinically significant PCa while avoiding unnecessary biopsies and aim to decide who to biopsy (PHI, 4Kscore®, SelectMDx®, MiPS) and when to re-biopsy (PCA3 and ConfirmMDx®).

• PCA3 shows promising results in men with one or more previous negative biopsies in order to determine whether to repeat biopsy, nevertheless, its clinical effectiveness for this purpose is still uncertain.

• When PHI, 4Kscore®, and SelectMDx® were assessed together with mpMRI, these markers seem to work complementarily considering the prediction of csPCa.

• ConfirmMDx® might help to distinguish true negative biopsies from those with possible occult cancer, and therefore avoid a considerably high number of repeat biopsies.

• Oncotype DX®, Prolaris®, and ProMark® might help do decide who to treat, whereas Prolaris® and Decipher® try to identify patients who might be at risk for distant metastases and therefore need further treatment.

• Even if some of the markers have shown good predictive values, most are not yet validated and scientifically mature for daily practice.

• The real challenge is to find the best combination which includes biomarkers and clinical data without increasing the cost and the risk of over-diagnosis.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewers disclosure

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.