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The positive surgical margin (PSM) and biochemical recurrence (BCR) are two main factors associated with poor oncotherapeutic outcomes after prostatectomy. This is an Asian population study based on a single-surgeon experience to deeply investigate the predictors for PSM and BCR. We retrospectively included 419 robot-assisted radical prostatectomy cases. The number of PSM cases was 126 (30.1%), stratified as 22 (12.2%) in stage T2 and 103 (43.6%) in stage T3. Preoperative prostate-specific antigen (PSA) > 10 ng/mL (p = 0.047; odds ratio [OR] 1.712), intraoperative blood loss > 200 mL (p = 0.006; OR 4.01), and postoperative pT3 stage (p < 0.001; OR 6.901) were three independent predictors for PSM while PSA > 10 ng/mL (p < 0.015; hazard ratio [HR] 1.8), pT3 stage (p = 0.012; HR 2.264), International Society of Urological Pathology (ISUP) grade > 3 (p = 0.02; HR 1.964), and PSM (p = 0.027; HR 1.725) were four significant predictors for BCR in multivariable analysis. PSMs occurred mostly in the posterolateral regions (73.8%) which were associated with nerve-sparing procedures (p = 0.012) while apical PSMs were correlated intraoperative bleeding (p < 0.001). A high ratio of pT3 stage after RARP in our Asian population-based might surpass the influence of PSM on BCR. PSM was less significant than PSA and ISUP grade for predicting PSA recurrence in pT3 disease. Among PSM cases, unifocal and multifocal positive margins had a similar ratio of the BCR rate (p = 0.172) but ISUP grade > 3 (p = 0.002; HR 2.689) was a significant BCR predictor. These results indicate that PSA and pathological status are key factors influencing PSM and BCR., (© 2021. The Author(s).)

To evaluate the performance of the Prostate Health Index (PHI) in magnetic resonance imaging-transrectal ultrasound (MRI-TRUS) fusion prostate biopsy for the detection of clinically significant prostate cancer (csPCa). We prospectively enrolled 164 patients with at least one Prostate Imaging Reporting and Data System version 2 (PI-RADS v2) ≥ 3 lesions who underwent MRI-TRUS fusion prostate biopsy. Of the PSA-derived biomarkers, the PHI had the best performance in predicting csPCa (AUC 0.792, CI 0.707-0.877) in patients with PI-RADS 4/5 lesions. Furthermore, the predictive power of PHI was even higher in the patients with PI-RADS 3 lesions (AUC 0.884, CI 0.792-0.976). To minimize missing csPCa, we used a PHI cutoff of 27 and 7.4% of patients with PI-RADS 4/5 lesions could have avoided a biopsy. At this level, 2.0% of cases with csPCa would have been missed, with sensitivity and NPV rates of 98.0% and 87.5%, respectively. However, the subgroup of PI-RADS 3 was too small to define the optimal PHI cutoff. PHI was the best PSA-derived biomarker to predict csPCa in MRI-TRUS fusion prostate biopsies in men with PI-RADS ≥ 3 lesions, especially for the patients with PI-RADS 3 lesions who gained the most value.

Background: In vitro studies have confirmed that cardiac glycosides can induce apoptosis in both hormone-dependent and -independent prostate cancer (PCa) cell lines. The aim of this study was to investigate the incidence of PCa among patients treated with and without digoxin using a nationwide population-based database in Taiwan., Methods: We retrieved data of men aged 30 years or older who were newly diagnosed with heart failure between January 1998 and December 2003 from the National Health Insurance program database in Taiwan. We divided the patients into digoxin users and non-digoxin users. Kaplan-Meier curves and Cox proportional hazard analysis were used to examine the risk of subsequent PCa between the digoxin and non-digoxin groups., Results: The mean ± SD follow-up (years) periods in the digoxin and non-digoxin groups were 8.6 ± 1.78 and 8.3 ± 1.75, respectively. The cumulative incidence of PCa during the follow-up period was 3.5% (147/4233) in the non-digoxin group compared with 3.0% (65/2154) in the digoxin group. The log-rank test revealed that the digoxin group had a similar incidence of PCa to the non-digoxin group (p = 0.18). After adjusting for age, benign prostatic hyperplasia, and comorbidities, Cox proportional hazard regression analysis showed that digoxin was associated with a significantly decreased risk of developing PCa (hazard ratio, 0.74; 95% CI, 0.548-0.993; p = 0.045). Moreover, logistic regression analysis showed that the risk of PCa decreased with a longer duration of digoxin use during the study period compared to those who had never used digoxin (p = 0.043)., Conclusion: The cardiac glycoside digoxin had significant effects on reducing the incidence of PCa in a time-dependent manner. Our findings may imply the potential application of cardiac glycosides in the prevention and management of PCa.

Background: There are models to predict pathological outcomes based on established clinical and prostate-specific antigen (PSA)-derived parameters; however, they are not satisfactory. p2PSA and its derived biomarkers have shown promise for the diagnosis and prognosis of prostate cancer (PCa). The aim of this study was to investigate whether p2PSA-derived biomarkers can assist in the prediction of aggressive pathological outcomes after radical prostatectomy (RP)., Methods: We prospectively enrolled patients who were diagnosed with PCa and treated with RP between February 2017 and December 2018. Preoperative blood samples were analyzed for tPSA, free PSA (fPSA), percentage of fPSA (%fPSA), [-2]proPSA (p2PSA), and percentage of p2PSA (%p2PSA). Prostate health index (PHI) was calculated as (p2PSA/fPSA) × √tPSA. Prostate volume was determined by transrectal ultrasound using the ellipsoid formula, and PHI density was calculated as PHI/prostate volume. The areas under the receiver operating characteristic curve were estimated for various PSA/p2PSA derivatives. Aggressive pathological outcomes measured after RP were defined as pathological T3 or a Gleason score (GS) >6 as determined in RP specimens., Results: One hundred and forty-four patients were included for analysis. Postoperative GS was >6 in 86.1% of the patients, and pT stage was T3a or more in 54.2%. Among all PSA- and p2PSA-derived biomarkers, PHI density was the best biomarker to predict aggressive pathological outcomes after RP. The odds ratio of having an aggressive pathological outcome of RP was 8.796 (p = 0.001). In multivariate analysis, adding %fPSA to base model did not improve the accuracy (area under curve), but adding PHI and PHI density to base model improved the accuracy by 2% and 16%, respectively, in predicting pT3 stage or GS ≥ 7. The risk of pT3 stage or GS ≥ 7 was 20.8% for PHI density <1.125, and 64.6% for PHI density >1.125 (sensitivity: 74.6% and specificity: 88.9%)., Conclusion: PHI density may further aid in predicting aggressive pathological outcomes after RP. This biomarker may be useful in preoperative counseling and may have potential in decision making when choosing between definitive treatment and active surveillance of newly diagnosed PCa.

Background: Few prospective studies have focused on the performance of the Prostate Health Index (PHI) in Asian populations. Therefore, we aimed to evaluate the performance of the PHI in predicting prostate cancer (PCa) compared with standard prostate-specific antigen (PSA) tests., Methods: We prospectively enrolled patients with suspected PCa with a total PSA (tPSA) level 4 to 10 ng/mL or tPSA <4 ng/mL and a suspicious digital rectal examination between February 2017 and September 2018. All of the patients underwent a 12-core transrectal ultrasound-guided prostate biopsy. Prebiopsy blood samples were analyzed for tPSA, free PSA (fPSA), percentage of fPSA (%fPSA), [-2]proPSA (p2PSA), and percentage of p2PSA (%p2PSA). The PHI was calculated as (p2PSA/fPSA) × √tPSA. The areas under the receiver operating characteristic curve (AUCs) were estimated for the PSA derivatives in addition to their specificities at a prespecified sensitivity of 90%., Results: Of the 307 enrolled patients, 95 (30.9%) had PCa on biopsy. Excluding fPSA, all of the PSA derivatives were significantly different between the positive and negative biopsy groups. Of the various derivatives, the PHI (AUC: 0.783) showed the best performance in predicting the results of the initial biopsy compared with tPSA (AUC: 0.611). At a sensitivity of 90%, the PHI had the best specificity of 46.7% compared with 23.2% for tPSA. Using a PHI cutoff value of 35.15 for biopsy, 108 (35.2%) patients could have avoided undergoing a biopsy. To detect Gleason score ≥ 7 disease at 90% sensitivity, the threshold for PHI was 36.96 with a specificity of 52.1%., Conclusion: PHI was the best biomarker among the PSA derivatives in predicting PCa at biopsy in men with tPSA < 10 ng/mL. The risk of a Gleason score ≥ 7 increased with increasing PHI.

Background: Prostate cancer (PCa) is not commonly found in men younger than 50 years of age. However, serum prostate-specific antigen (PSA) concentration has been examined more frequently at a younger age in Asia partially due to an increased awareness of prostate cancer. The purpose of our study was to investigate the efficacy and complication of PSA-triggered transrectal ultrasonography-guided prostate (TRUSP) biopsies. We retrospectively reviewed TRUSP biopsies in young men with elevated PSA concentration in Taipei Veterans General Hospital., Methods: We reviewed the cases of patients younger than 50 years of age with elevated PSA concentration (>4.0 ng/mL), who received 12 cores TRUSP biopsies at TPEVGH from January 2008-December 2013. The age, family history, digital rectal examination (DRE) results, PSA concentration, free/total PSA ratio, total prostate volume, PSA density, lower urinary tract symptoms and complications after the procedure were reviewed. The pathologic findings of TRUSP biopsy and clinical follow-up were reviewed and analyzed according to the Epstein criteria., Results: A total of 77 patients were included and were divided into 2 groups: 1) the younger group consisted of 20 patients <40 years of age; and 2) the elder group had 57 patients who were 40-50 years of age. The overall detection rate of PCa was 11.69% (9/77), and all of the PCa cases were diagnosed in the elder group (group detection rate: 15.8%). There was a significant difference in the severity of lower urinary tract symptoms (LUTS) between these 2 groups. All PCa patients were clinically significant according to the Epstein criteria. Two patients experienced fever (2.60%) after TRUSP biopsy., Conclusion: From our patient cohort, it appears that no benefit was apparent for patients younger than 40 years old who received TRUSP biopsy, even with elevated PSA. However, PCa detected in men between 40 and 50 years of age were all clinically significant. Overall, our results supported current major practice guidelines which recommend an initial PSA checkup at 40 years of age., (Copyright © 2017. Published by Elsevier Taiwan LLC.)

Background: In the general population, prostate adenocarcinoma affects predominately older men. If fact, most current guidelines suggest that males over the age of 50 years should undergo prostate cancer screening. However, the clinical behavior and prognosis of prostate cancer in young adults is not well defined. The aim of this study was to evaluate the clinical behavior, pathological characteristics, and prognosis of prostate cancer in young adults., Methods: We retrospectively reviewed the records of young patients (age, ≤50 years) in our hospital with prostate adenocarcinoma between 1997 and 2013. We compared data including initial presentation, cancer cell type, Gleason score, disease stage, prostate-specific antigen (PSA) level, prostate volume, treatment, and survival between patients both younger and older than 50 years. Data were analyzed using the Kaplan-Meier method to assess survival., Results: Twenty-six patients were enrolled in our study, accounting for 0.55% of all patients with a diagnosis of prostate cancer at our facility. All 26 patients had a pathology diagnosis of adenocarcinoma, with a mean age on diagnosis of 46.8±2.8 years (range, 39-50 years). On initial presentation, patients older than 50 years more frequently displayed lower urinary tract symptoms (LUTS) than younger patients (62.3% vs. 30.4%, p=0.008). There was no statistical difference in histological grade, disease stage, PSA level, overall survival, and biochemical-free survival between the two groups., Conclusion: The result of our investigation indicated that prostate adenocarcinoma patients younger than 50 years had similar histological grade, disease stage, PSA level, overall survival, and biochemical-free survival as the older population. However, patients younger than 50 years with prostate cancer less frequently showed initial symptoms of LUTS., (Copyright © 2016. Published by Elsevier Taiwan LLC.)

Background: Radical prostatectomy (RP) is one of the curative treatment options for patients with prostate cancer to achieve long-term survival, but it is accompanied by potential complications. The Martin criteria used as a format for reporting complications has become standard in recent years. However, it has not been applied in RP in Asian countries. In the present study, we investigated the early complications of RP developing within 90 days in our institute according to the Martin criteria., Methods: Between January 2003 and November 2011, patients with organ-confined adenocarcinoma of the prostate who received RP in our institute were retrospectively reviewed. The operation was done as open RP, or minimally invasive RP, including laparoscopic RP and robot-assisted laparoscopic RP (RaLP). The preoperative, operative, postoperative, and pathological parameters were recorded for analysis. Definitions of complications were adopted from previous reports. Surgical and medical complications developed within 90 days postoperatively were identified respectively; severity of each complication was classified according to Clavien-Dindo classification. Clavien-Dindo classification grade III or higher complications were viewed as major complications., Results: A total of 359 patients were included; 280 (78%) underwent open RP, 45 (12.5%) received laparoscopic RP, and 34 (9.5%) had RaLP. The overall complication rate was 40.1%, and the major complication rate was 13.1%. There was no surgical mortality. Diarrhea requiring conservative treatment (13.6%), minor urine leakage (9.5%), and gout attack (4.2%) were the leading complications. Minimally invasive RP had higher rates of lymph leakage (p = 0.015) and upper-extremity neuropathy (p = 0.048). Body mass index >25 kg/m(2) and use of neoadjuvant hormone therapy were predictors for overall and major complications, whereas diabetes mellitus also predicted the development of major complications. Besides lower case volume and learning curve for RaLP, patients' higher age at surgery and higher risk for disease progression compared to the Western series may be responsible for the higher complication rates., Conclusion: The early complication rates of RP in our patients were slightly high compared to the Western series. By standardized report, being overweight, diabetes mellitus, and use of neoadjuvant hormone therapy were identified as predictors of early complications in our series., (Copyright © 2014. Published by Elsevier B.V.)

Background: Discordance between the Gleason scores of prostate needle biopsies and radical prostatectomy specimens has been reported by several investigators. We conducted this study to determine if increasing the number of prostate needle biopsies in patients with prostate cancer improves the accuracy of Gleason scores in the Taiwanese population., Methods: Between March 2000 and September 2009, 281 patients underwent radical prostatectomy at Taipei Veterans General Hospital. All of these patients had prostate cancer that was diagnosed and graded either by extended needle biopsy (121 patients, ≥ 10 cores/patient, range: 10-13, median: 12) or by traditional sextant transrectal biopsy (160 patients, <10 cores/patient, range: 6-9, median: 6). We analyzed the patients' Gleason scores of their biopsies and radical prostatectomy specimens., Results: The concordance rate, defined as similarity between the Gleason score of a patient's biopsy and prostatectomy specimens, was 57.9% in the extended biopsy group and 45.6% in the nonextended biopsy group (χ(2) test: p = 0.042). The primary Gleason pattern was accurately predicted by extended needle biopsy in 81% of cases (98/121 cases), higher than the 70% accuracy rate of the nonextended biopsies (112/160 cases, p = 0.036). Undergrading was found in 43/121 cases (32%) and 63/160 cases (39.4%) (p = 0.511). However, overgrading was found in 8/121 cases (6.6%) and in 24/160 cases (15.0%) (p = 0.028) by extended and nonextended biopsies, respectively. Forty-seven (16.7%) of those patients who fit the criteria of active surveillance were upgraded to a Gleason score >7 after radical prostatectomy., Conclusion: The addition of an extended transrectal needle biopsy increases the accuracy of the Gleason score for predicting the final prostate cancer grade in the Taiwanese population., (Copyright © 2012. Published by Elsevier B.V.)

Background: Transrectal ultrasound-guided biopsy of the prostate is the major method by which prostate cancer is diagnosed. However, many patients might be overlooked with the initial biopsy. Not uncommonly, patients need repeated biopsies when they continue to exhibit suspicious clinical signs. This may cause psychological stress to both patients and doctors. The purpose of this study was to determine how many repeat transrectal biopsies are adequate for prostate cancer detection and when to switch to transurethral resection., Methods: We retrospectively studied a cohort of 2,996 patients who had undergone prostate biopsy. If the biopsy specimen was negative for malignancy, patients were given the choice of either being managed with observation or undergoing transurethral resection of the prostate (TURP) if indicated. If there was a high suspicion of cancer, patients were advised to undergo additional biopsies. The primary endpoint of this study was a diagnosis of cancer., Results: The cancer detection rate was 22.9% (685 of 2,996 patients) in specimens taken during the first transrectal biopsy, 8.7% in those taken during the second biopsy (32 of 336 patients), and 6.1% in those taken during the third biopsy (6 of 98 patients). The cancer detection rate of TURP after 1 negative biopsy result was 9.3% (35 of 375 patients), and that after 2 negative biopsy results was 17.1% (6 of 35 patients). TURP-derived specimens that were pathologically diagnosed as malignant had lower Gleason grade on average, no matter how many repeat biopsies there were in patients whose previous transrectal biopsy specimens were negative for malignancy (p=0.002 for 2 negative biopsy results and p=0.007 for 3 negative biopsy results)., Conclusion: The chance of detecting malignancy beyond a third transrectal biopsy procedure is low. TURP, therefore, might be an alternative procedure for obtaining tissue for pathologic diagnosis, especially in patients with rising prostate-specific antigen levels and comorbid illnesses such as obstructive symptoms.

Purpose: Serum prostate specific antigen (PSA) level is increased after needle biopsy (Bx) of the prostate. This study tested the hypothesis that the prostate harboring malignant lesions demonstrates less leakage of PSA after prostate biopsy and this phenomenon can be helpful in discriminating benign from cancer diagnosis., Materials and Methods: This prospective study was divided into 3 separate phases. Sextant prostate biopsy was done with transrectal ultrasound guidance, and the change and PSA values after biopsy were evaluated. Phases 1 and 2 had 20 and 41 patients, respectively. PSA dynamic profiles were plotted. We defined the most appropriate timing for blood sampling and the cutoff value of the PSA ratio (post-Bx total PSA-to-pre-Bx total PSA) to be applied for further assessment. Phase 3 recruited 97 cases, of which 66 satisfied the end point criteria in which a diagnosis such as malignancy, or 3 successive benign biopsies or benign transurethral resection of prostate was obtained., Results: From phases 1 and 2 the cutoff value for the PSA ratio was 2.0, and the timing of blood sampling was 60 minutes after the biopsy. In phase 3 of those whose PSA ratio was less than 2.0, 92.6% (25) had cancer. For those whose PSA ratio was greater than 2.0, 82.1% (32) were benign. Of the 4 cases with a PSA ratio less than 2.0 and an initial benign biopsy, 3 (75%) were proven to have cancer later., Conclusions: Evaluating the 1-hour PSA ratio might be helpful for clinicians to select the high risk patients who might have cancer in the prostate. Repeat biopsy should be suggested for cases with a smaller PSA ratio in spite of initial benign results.

Background: Antiandrogens available for patients with advanced prostate cancer are reported to cause hepatotoxicity. The aim of this study is to investigate the antiandrogen-associated hepatotoxicity in patients with advanced prostate cancer., Methods: By retrospective charts review, 229 patients (47-89 years old) with advanced prostate cancer treated by total androgen blockade (TAB) with bilateral orchiectomy or LHRH (luteinizing hormone-releasing hormone) analogues plus antiandrogen, or antiandrogen-radiotherapy were enrolled in this study. There were 124 patients taking flutamide 750 mg daily and 105 patients taking cyproterone acetate (CPA) 150 mg daily. Hepatotoxicity defined by the International Consensus Meeting in 1990 and Food and Drug Administration, USA was used to evaluate the hepatotoxicity (including serious hepatotoxicity)., Results: There was a higher occurrence of hepatotoxicity in patients taking flutamide (15.3%) than taking CPA (9.5%) (p = 0.034). The occurrence of serious hepatotoxicity of flutamide and CPA was 4.8% (6/124) and 3.8% (4/105), respectively. The mean latency period of hepatotoxicity for CPA was 4.8 +/- 2.0 months for flutamide and 5.8 +/- 1.9 months for CPA, respectively. The 2 groups made no significant difference of liver enzyme (mean maximal alanine aminotransaminase (ALT) and aspartate aminotransaminase (AST) = 284.2 +/- 99.3/300.6 +/- 58.5 U/L versus 341.8 +/- 67.1/301.6 +/- 80.5 U/L). All of the 19 patients (100%) and 9 of 10 patients (90%) with flutamide and CPA-induced hepatotoxicity got self-resolution after discontinuation of the antiandrogens. The average time of self-resolution is 4.5 +/- 3.1 months and 6.3 +/- 4.7 months for flutamide and CPA, respectively. Five patients of flutamide-induced and 2 patients of CPA-induced hepatotoxicity got resolution after changing to other antiandrogen., Conclusions: Flutamide and CPA appear to cause hepatotoxic effects in some patients. Discontinuation of the antiandrogens seems to be the resolution of hepatotoxicity. A change to other antiandrogen may be the alternative strategy to the antiandrogen-induced hepatotoxicity. The results of this study suggest that all patients received flutamide and CPA should be monitored carefully for signs and symptoms referable to hepatic injury to prevent the development of serious hepatic dysfunction.