攝護腺健康指數可改善預測有磁振造影PI-RADS 3病灶之病患接受磁振超音波融合導引攝護腺切片之臨床顯著攝護腺癌

潘柏勳¹、范玉華^1,2,3、林子平^1,2,3、程威銘^2,4、王信凱^2,5、沈書慧^2,5、劉顯慈^2,5、陳威任^1,2,3、

黃子豪^1,2,3、魏子鈞^1,2,3、黃奕燊^1,2,3、林志杰^1,2,3、黃逸修^1,2,3、鍾孝仁^1,2,3、黃志賢^1,2,3

¹台北榮民總醫院 泌尿部；²陽明大學醫學院泌尿學科；³書田泌尿學研究中心；

⁴臺北市立聯合醫院 忠孝分院 泌尿科；⁵台北榮民總醫院 放射線部

Prostate Health index helps to predict positive biopsy of significant prostate cancer for PI-RADS 3 lesion underwent MRI-TRUS fusion-targeted prostate biopsy

Po-Hsun Pan¹, Yu-Hua Fan ^1,2,3, Tzu-Ping Lin ^1,2,3, Wei-Ming Cheng^2,4, Hsin-Kai Wang^2,5,

Shu-Huei Shen^2,5, Hsian-Tzu Liu^2,5, Wei-Ren Chen^1,2,3, Tzu-Hao Huang^1,2,3, Tzu-Chun Wei^1,2,3,

I-Shen Huang^1,2,3, Chih-Chieh Lin^1,2,3, Eric Y.H. Huang^1,2,3, Hsiao-Jen Chung^1,2,3, William J.S. Huang^1,2,3

¹Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan

²Department of Urology, School of Medicine, National Yang-Ming University, Taipei, Taiwan

³Shu-Tien Urological Institute, National Yang-Ming University, Taipei, Taiwan;

⁴Division of Urology, Department of Surgery, Zhongxiao Branch, Taipei City Hospital, Taipei, Taiwan

⁵Department of Radiology, Taipei Veterans General Hospital, Taipei, Taiwan

Purpose: Major technical improvements in multiparametric MRI (mpMRI) of prostate with the standard approach to interpretation using the PI-RADS v2 offers reliable visualization of potentially clinically significant prostate cancer (csPca) and thus has shown advantages as a means by which to better select patients for biopsy and facilitate direct targeting of lesions during biopsy. However, currently available data show that the actual prevalence of csPCa after targeted biopsy in PI-RADS 3 lesions vary from 16% to 21%. We hypothesize that a newer biomarkers prostate health index (PHI) may better stratify a higher risk subgroup that harbor csPCa in patients with PI-RADS 3 lesions.

Materials and Methods: Patients with at least one PI-RADS = 3 lesion on mpMRI were enrolled for cognitive MRI-TRUS fusion-targeted prostate biopsy. All these patients had either PSA greater than 4 ng/ml and/or suspicious digital rectal examination (DRE). All patients had received PHI test before the prostate biopsy. AUC under the ROC curves were estimated for the various PSA derivatives, along with the specificity at a pre-specified sensitivity of 90%.

Results: As PI-RADS 3 lesions have relatively low rates of csPCa and may present a new “grey zone” cognitive MRI-TRUS fusion-targeted prostate biopsy. Adding PHI to mpMRI improved predictive performance for overall PCa (AUC 0.818, CI 0.702-0.934) and csPCa detection (AUC 0.881, CI 0.787-0.975). The PHI alone was a significant predictor for any cancer (OR 5.95, 95% CI 1.35–42.36, p = 0.026) and significant cancers (OR 12.41, 95% CI 3.06–28.4, p < 0.001) after adjusting for age, prostate volume, previous negative biopsy and abnormal DRE by logistic regression. We found the optimal cutoff to be ≥ 39.7 which would allow 39.3 % of patients to avoid biopsy. At this level, no csPCa was missed and both sensitivity and NPV were 100%.

Conclusions: In patients with PI-RADS 3 index lesions, which is a gray zone for PI-RADS v2, PHI exhibits good performance in predicting csPCa. Using a PHI cutoff of ≥ 39.7, up to 39 % of prostate biopsy could be avoided in patients with PI-RADS 3 lesions and no csPCa was missed.