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• Prostate cancer is the most common solid tumor in men and the second leading cause of cancer death. • PSA based diagnosis leads to unnecessary biopsies, overdiagnosis of low malignant disease and potential overtreatment. • Prostate Health Index is a novel tool that improves diagnosis, mostly in PSA 4-10 and normal digital rectal examination. • PHI and its density have better diagnostic performance than the most commonly used biomarkers. Prostate health index (PHI) is a predictive biomarker of positive prostate biopsy. The majority of evidence refers to its use in the PSA gray zone (4–10 ng/mL) and negative digital rectal exam (DRE). We aim to evaluate and compare the predictive accuracy of PHI and PHI density (PHId) with PSA, percentage of free PSA and PSA density, in a wider range of patients for the detection of clinically significant prostate cancer (csPCa). Multicenter prospective study that included patients suspicious of harboring prostate cancer. Non-probabilistic convenience sampling, where men who attended the urology consultation were tested for PHI before prostate biopsy. To evaluate and compare diagnostic accuracy AUC and decision curve analysis (DCA) were calculated. All these procedures were performed for the overall sample and the following subsamples: PSA < 4 ng/ml; PSA 4–10 ng/ml; PSA 4–10 ng/ml plus negative DRE and PSA > 10 ng/ml. Among the 559 men included, 194 (34.7%) were diagnosed of csPCa. PHI and PHId outperfomed PSA in all subgroups. PHI best diagnostic performance was found in PSA 4–10 ng/ml with negative DRE (sensitivity 93.33, NPV 96.04). Regarding AUC, significant differences were found between PHId and PSA in the subgroup of PSA 4–10 ng/ml, whatever DRE status. In DCA, PHI density shows the highest net benefit. PHI and PHId outperfom PSA in csPCa detection, not only in the PSA grey zone with negative DRE, but also in a wider range of PSA values. There is an urgent need of prospective studies to established a validated threshold and its incorporation in risk calculators. [ABSTRACT FROM AUTHOR]