Prostate health index enhances prostate cancer management in Chinese populations: evidence from the nation’s large cohort and transnational multicohort harmonization

BACKGROUND: The escalating global burden of prostate cancer (PCa) demands accurate diagnostics to optimize management. Conventional prostate-specific antigen (PSA) testing exhibits low specificity and overdiagnosis, compromising its reliability. While the Prostate Health Index (PHI) may enhance precision, large-scale Asian clinical evidence and systematic evaluations of PHI’s standalone/combined diagnostic efficacy remain limited, hindering its broader clinical adoption. METHODS: A retrospective analysis was conducted on hospitalized patients initially diagnosed with PCa or BPH at Wuhan Tongji Hospital over the past three years. Receiver operating characteristic (ROC) curves assessed PHI’s diagnostic performance across clinical scenarios. Binary diagnostic tests simulating real-world clinical settings were performed to assess the practical utility of PSA, PHI, and PI-RADS scores. Furthermore, a multiparameter pre-biopsy diagnostic model integrating PHI with complementary methods was developed. Finally, a systematic review and meta-analysis of PHI-related studies were conducted to comprehensively assess its diagnostic accuracy and robustness. RESULTS: The study included 2,091 patients, forming the largest Asian cohort for PHI-based diagnosis. ROC analysis revealed that PHI significantly outperformed PSA in diagnosing both PCa and clinically significant PCa (csPCa) (P < 0.001), with enhanced diagnostic superiority in the PSA gray zone (4–10 ng/mL). At a cutoff value of 30, PHI achieved 90% sensitivity for csPCa while maintaining superior performance to PSA in binary diagnostic testing. A risk prediction model integrating PHI with PI-RADS scores was constructed through regression analysis, effectively reducing unnecessary biopsy referrals. Meta-analysis further confirmed the robust diagnostic performance of PHI and its combined use with PI-RADS scores, with better performance observed in Asian populations compared to Western countries. CONCLUSION: This large-scale cohort study and updated meta-analysis validate PHI’s clinical utility for PCa diagnosis in Asian populations. The integration of PHI with PI-RADS scores demonstrates significant clinical benefit, positioning PHI as a precise, reliable tool to advance PCa care in Asia.