Peter K-F Chiu1, Chi-Fai Ng2, Axel Semjonow3, Yao Zhu4, Sébastien Vincendeau5, Alain Houlgatte6, Massimo Lazzeri7, Giorgio Guazzoni8, Carsten Stephan9, Alexander Haese10, Ilse Bruijne11, Jeremy Yuen-Chun Teoh12, Chi Ho Leung12, Paola Casale7, Chih Hung Chiang13, Lincoln Guan-Lim Tan14, Edmund Chiong14, Chao Yuan Huang15, Hsi Chin Wu16, Daan Nieboer17, Ding-Wei Ye4, Chris H Bangma11, Monique J Roobol11. 1. Department of Urology, Erasmus MC, Rotterdam, The Netherlands; Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China. Electronic address: peterchiu@surgery.cuhk.edu.hk. 2. Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China; SH Ho Urology Centre, The Chinese University of Hong Kong, Hong Kong, China. Electronic address: ngcf@surgery.cuhk.edu.hk. 3. Department of Urology, Prostate Center, University Clinic Münster, Münster, Germany. 4. Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, China. 5. Department of Urology, Hospital Pontchaillou, Rennes, France. 6. Department of Urology, HIA Du Val De Grace, Paris, France. 7. Department of Urology, Istituto Clinico Humanitas IRCCS, Rozzano, Italy. 8. Department of Urology, Humanitas University, Rozzano, Italy. 9. Department of Urology, Charite-Universitaetsmedizin and Berlin Institute for Urologic Research, Berlin, Germany. 10. Martini Clinic Prostate Cancer Centre, University Clinic Eppendorf, Hamburg, Germany. 11. Department of Urology, Erasmus MC, Rotterdam, The Netherlands. 12. Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China; SH Ho Urology Centre, The Chinese University of Hong Kong, Hong Kong, China. 13. Department of Surgery, Taipei Veterans General Hospital and Su-Ao/Yuan-Shan Branch, Yi-Lan, Taiwan. 14. Department of Urology, University Surgical Cluster, National University Health System, Singapore. 15. Department of Urology, National Taiwan University Hospital, Taipei, Taiwan. 16. Department of Urology, China Medical University, Taichung, Taiwan. 17. 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 2-20ng/ml and PHI test and transrectal ultrasound-guided biopsy results available. Of these, 1652 men had PSA 2-10ng/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 10-20ng/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.
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 2-20ng/ml and PHI test and transrectal ultrasound-guided biopsy results available. Of these, 1652 men had PSA 2-10ng/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 10-20ng/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.