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Aim Prostate health index (PHI) is a diagnostic test for prostate cancer that combines free prostate specific antigen (PSA), total PSA and [-2]proPSA. PHI has been shown to be more accurate than PSA testing at detecting prostate cancer and its use has been shown to reduce unnecessary prostate biopsies. Prostate health index density (PHID), derived by dividing PHI by prostate volume, has been suggested as a more accurate test compared to standard PHI by several authors. The aim of this systematic review was to evaluate the diagnostic accuracy of PHID for clinically significant prostate cancer, identify an optimal diagnostic threshold and assess the clinical utility of PHID as a novel diagnostic test for prostate cancer. Method A systematic review of primary studies was conducted. Medline, Embase, Scopus and Cochrane databases were searched with key terms. Results were screened and full papers reviewed by two reviewers with pre-determined inclusion criteria. QUADAS-2 was used for quality appraisal. Data analysis was conducted in line with PRISMA guidelines. Results Nine studies were included. Quality appraisal revealed a high degree of heterogeneity between studies. PHID thresholds ranged 0.32-1.38. PHID had an area under the curve value of 0.59-0.9 and negative predictive value of 81-100% for clinically significant disease. PHID outperformed PHI in three studies, but this was not replicated in the other studies. Conclusions This systematic review found PHID did not consistently outperform PHI. PHID was found to have low clinical utility in the diagnosis of prostate cancer based on the available evidence, with further research warranted.

1226 The Clinical Utility of Prostate Health Index Density in The Diagnosis of Clinically Significant Prostate Cancer: A Systematic Review