Rong Na1,2,3,4,5, Dingwei Ye6, Jun Qi7, Fang Liu2, Brian T Helfand8, Charles B Brendler8, Carly A Conran3, Vignesh Packiam8, Jian Gong2, Yishuo Wu1,2, Siqun L Zheng3, Zengnan Mo9, Qiang Ding1,2, Yinghao Sun10, Jianfeng Xu2,3. 1. Department of Urology, Huashan Hospital, Fudan University, Shanghai, PR China. 2. Fudan Institute of Urology, Huashan Hospital, Fudan University, Shanghai, PR China. 3. Program for Personalized Cancer Care, NorthShore University HealthSystem, Evanston, Illinois. 4. Department of Surgery, Pritzker School of Medicine, University of Chicago, Chicago, Illinois. 5. Fudan Universtiy Shanghai Medical College, Shanghai, PR China. 6. Department of Urology, Shanghai Cancer Center, Fudan University, Shanghai, PR China. 7. Department of Urology, Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, PR China. 8. Division of Urology, NorthShore University HealthSystem, Evanston, Illinois. 9. Center for Genomic and Personalized Medicine, Guangxi Medical University, Nanning, Guangxi, PR China. 10. Department of Urology, Shanghai Changhai Hospital, The Second Military Medical University, Shanghai, PR China.
Abstract
BACKGROUND: The performance of prostate health index (phi) in predicting prostate biopsy outcomes has been well established for patients with prostate-specific antigen (PSA) values between 2 and 10 ng/mL. However, the performance of phi remains unknown in patients with PSA >10 ng/mL, the vast majority in Chinese biopsy patients. We aimed to assess the ability of phi to predict prostate cancer (PCa) and high-grade disease (Gleason Score ≥7) on biopsy in a Chinese population. METHODS: This is a prospective, observational, multi-center study of consecutive patients who underwent a transrectal ultrasound guided prostate biopsy at four hospitals in Shanghai, China from August 2013 to December 2014. RESULTS: In the cohort of 1538 patients, the detection rate of PCa was 40.2%. phi had a significantly better predictive performance for PCa than total PSA (tPSA). The areas under the receiver operating characteristic curve (AUC) were 0.90 and 0.79 for phi and tPSA, respectively, P < 0.0001. A considerable proportion of patients in the cohort had PSAs >10 ng/mL (N = 838, 54.5%). The detection rates of PCa were 35.9% and 57.7% in patients with tPSA 10.1-20 and 20.1-50 ng/mL, respectively. The AUCs of phi (0.79 and 0.89, for these two groups, respectively) were also significantly higher than tPSA (0.57 and 0.63, respectively), both P < 0.0001. If a phi ≤35 was used as the cutoff, 599/1538 (39%) biopsies could have been avoided at a cost of missing small numbers of PCa patients: 49 (7.93%) PCa patients, including 18 (3.69%) high-grade tumors. CONCLUSIONS: Results from this study suggest that phi can be used to predict PCa and high-grade disease in Chinese men with high PSA levels (>10 ng/mL).
BACKGROUND: The performance of prostate health index (phi) in predicting prostate biopsy outcomes has been well established for patients with prostate-specific antigen (PSA) values between 2 and 10 ng/mL. However, the performance of phi remains unknown in patients with PSA >10 ng/mL, the vast majority in Chinese biopsy patients. We aimed to assess the ability of phi to predict prostate cancer (PCa) and high-grade disease (Gleason Score ≥7) on biopsy in a Chinese population. METHODS: This is a prospective, observational, multi-center study of consecutive patients who underwent a transrectal ultrasound guided prostate biopsy at four hospitals in Shanghai, China from August 2013 to December 2014. RESULTS: In the cohort of 1538 patients, the detection rate of PCa was 40.2%. phi had a significantly better predictive performance for PCa than total PSA (tPSA). The areas under the receiver operating characteristic curve (AUC) were 0.90 and 0.79 for phi and tPSA, respectively, P < 0.0001. A considerable proportion of patients in the cohort had PSAs >10 ng/mL (N = 838, 54.5%). The detection rates of PCa were 35.9% and 57.7% in patients with tPSA 10.1-20 and 20.1-50 ng/mL, respectively. The AUCs of phi (0.79 and 0.89, for these two groups, respectively) were also significantly higher than tPSA (0.57 and 0.63, respectively), both P < 0.0001. If a phi ≤35 was used as the cutoff, 599/1538 (39%) biopsies could have been avoided at a cost of missing small numbers of PCa patients: 49 (7.93%) PCa patients, including 18 (3.69%) high-grade tumors. CONCLUSIONS: Results from this study suggest that phi can be used to predict PCa and high-grade disease in Chinese men with high PSA levels (>10 ng/mL).
Authors: Da Huang; Yi-Shuo Wu; Ding-Wei Ye; Jun Qi; Fang Liu; Brian T Helfand; Siqun L Zheng; Qiang Ding; Dan-Feng Xu; Rong Na; Jian-Feng Xu; Ying-Hao Sun Journal: Asian J Androl Date: 2020 Sep-Oct Impact factor: 3.285