Proclarix, A New Biomarker for the Diagnosis of Clinically Significant Prostate Cancer: A Systematic Review.

INTRODUCTION

Multiparametric magnetic resonance imaging (mpMRI) has improved the early detection of clinically significant prostate cancer (csPCa). However, an appropriate selection of men for mpMRI or prostate biopsy is still challenging, which is why new biomarkers or predictive models are recommended to determine those patients who will benefit from prostate biopsy. Proclarix is a new test that provides the risk of csPCa based on thrombospondin-1 (THBS1), cathepsin D (CTSD), prostate-specific antigen (PSA), and percentage of free PSA (%fPSA), as well as age. This systematic review analyzes the current clinical status of Proclarix and future development.

EVIDENCE ACQUISITION

A systematic review of the literature was carried out by two independent reviewers. The Medical Subject Heading (MeSH) terms 'prostate', 'thrombospondin-1', 'cathepsin-D' and 'Proclarix' were used. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and the Population, Intervention, Comparison and Outcomes (PICO) selection criteria were followed. Finally, four articles analyzed the clinical usefulness of Proclarix.

EVIDENCE SYNTHESIS

Proclarix has been developed in men with PSA levels between 2 and 10 ng/mL, normal digital rectal examination (DRE), and prostate volume (PV)​ ≥ 35 cm. Proclarix is associated with the PCa grade group and is more effective than %fPSA in detecting csPCa. Two studies analyzed the efficacy of Proclarix in men undergoing guided and systematic biopsies, obtaining similar results to PSA density.

CONCLUSION

Initial studies have shown the potential benefit of Proclarix in patients with specific characteristics. Future studies are needed to verify the clinical usefulness of Proclarix in men with suspected PCa before and after mpMRI.