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A Multicentre Evaluation of the Role of the Prostate Health Index (PHI) in Regions with Differing Prevalence of Prostate Cancer: Adjustment of PHI Reference Ranges is Needed for European and Asian Settings
Authors:Peter K.-F. Chiu  Chi-Fai Ng  Axel Semjonow  Yao Zhu  Sébastien Vincendeau  Alain Houlgatte  Massimo Lazzeri  Giorgio Guazzoni  Carsten Stephan  Alexander Haese  Ilse Bruijne  Jeremy Yuen-Chun Teoh  Chi Ho Leung  Paola Casale  Chih Hung Chiang  Lincoln Guan-Lim Tan  Edmund Chiong  Chao Yuan Huang  Monique J. Roobol
Affiliation:1. Department of Urology, Erasmus MC, Rotterdam, The Netherlands;2. Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China;3. SH Ho Urology Centre, The Chinese University of Hong Kong, Hong Kong, China;4. Department of Urology, Prostate Center, University Clinic Münster, Münster, Germany;5. Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, China;6. Department of Urology, Hospital Pontchaillou, Rennes, France;7. Department of Urology, HIA Du Val De Grace, Paris, France;8. Department of Urology, Istituto Clinico Humanitas IRCCS, Rozzano, Italy;9. Department of Urology, Humanitas University, Rozzano, Italy;10. Department of Urology, Charite-Universitaetsmedizin and Berlin Institute for Urologic Research, Berlin, Germany;11. Martini Clinic Prostate Cancer Centre, University Clinic Eppendorf, Hamburg, Germany;12. Department of Surgery, Taipei Veterans General Hospital and Su-Ao/Yuan-Shan Branch, Yi-Lan, Taiwan;13. Department of Urology, University Surgical Cluster, National University Health System, Singapore;14. Department of Urology, National Taiwan University Hospital, Taipei, Taiwan;15. Department of Urology, China Medical University, Taichung, Taiwan;p. Department of Public Health, Erasmus University Medical Centre, Rotterdam, The Netherlands
Abstract:Asians have a lower incidence of prostate cancer (PC). We compared the performance of the Prostate Health Index (PHI) for 2488 men in different ethnic groups (1688 Asian and 800 European men from 9 sites) with PSA 2–20 ng/ml and PHI test and transrectal ultrasound-guided biopsy results available. Of these, 1652 men had PSA 2–10 ng/ml and a normal digital rectal examination and underwent initial biopsy. The proportions of PC (Gleason ≥6) and higher-grade PC (HGPC, Gleason ≥7) across different PHI ranges were compared. The performance of PSA and PHI was compared using the area under the receiver operating characteristic curve (AUC) and decision curve analyses (DCA). Among Asian men, HGPC would be diagnosed in 1.0%, 1.9%, 13%, and 30% of men using PHI thresholds of <25, 25–35, 35–55, and >55, respectively. At 90% sensitivity for HGPC (PHI >30), 56% of biopsies and 33% of Gleason 6 PC diagnoses could have been avoided. Among European men, HGPC would be diagnosed in 4.1%, 4.3%, 30%, and 34% of men using PHI thresholds of <25, 25–35, 35–55, and >55, respectively. At 90% sensitivity for HGPC (PHI >40), 40% of biopsies and 31% of Gleason 6 PC diagnoses could have been avoided. AUC and DCA confirmed the benefit of PHI over PSA. The benefit of PHI was also seen at repeat biopsy (n = 397) and for PSA 10–20 ng/ml (n = 439). PHI is effective in cancer risk stratification for both European and Asian men. However, population-specific PHI reference ranges should be used.

Patient summary

The Prostate Health Index (PHI) blood test helps to identify individuals at higher risk of prostate cancer among Asian and European men, and could significantly reduce unnecessary biopsies and overdiagnosis of prostate cancer. Different PHI reference ranges should be used for different ethnic groups.
Keywords:Biopsy  Prostate cancer  Prostate health index  [?2]pro–prostate-specific antigen  Decision curve analysis
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