A randomised, placebo-controlled, multicentre, Phase 2 clinical trial to evaluate the efficacy and safety of GV1001 in patients with benign prostatic hyperplasia.

OBJECTIVES: To evaluate the efficacy and safety of three dosing schemes of GV1001 in patients with benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: Eligible patients were men aged ≥50 years, with an International Prostate Symptom Score (IPSS) of ≥13, maximum urinary flow rate (Qmax ) of 5-15 mL/s, post-void residual urine volume (PVR) of ≤200 mL, and prostate volume of ≥30 mL. After a 4 week run-in period, patients were randomly assigned to one of three treatment schedules: Group 1, GV1001 0.4 mg, 2-week interval; Group 2, GV1001 0.56 mg, 2-week interval; Group 3, GV1001 0.56 mg, 4-week interval) or placebo (Group 4). The eligible patients were administered GV1001 or placebo, for a total of seven intradermal injections that were administered at 2-week intervals at weeks 0, 2, 4, 6, 8, 10, and 12. Treatment continued for 12 weeks, and efficacy was evaluated at weeks 4, 8, 12, 13, and 16. Safety was evaluated throughout the 16-week period. The primary efficacy variable was change from baseline (CFB) in total IPSS. Secondary endpoints were CFB in Qmax , PVR, prostate volume, International Index of Erectile Function score, plasma testosterone level, dihydrotestosterone level, and prostate-specific antigen level. RESULTS: A total of 161 patients were included (Group 1, n = 41; Groups 2-4, n = 40). Most patients (88.8%) received all planned doses of the study treatment. At week 13, a statistically significant difference in the mean CFB in IPSS was seen in GV1001 treatment Groups 1 and 2 vs the control group for the full analysis population (-3.5 [control] vs -7.2 and -6.8 in Groups 1 and 2, respectively; both P < 0.05). There were also statistically significant differences in CFB at weeks 8, 12, 13, and 16 in treatment Groups 1 and 2 vs control in the per-protocol population. There was a statistically significant reduction in prostate gland volume at week 16 vs control in all treatment groups (0.8 [control] vs -4.6, -2.5, and -4.2 mL in Groups 1-3, respectively; all P < 0.05). There were no statistically significant differences found in other secondary outcome measures. Adverse event (AE) reporting was similar across all four groups. No treatment-emergent AEs were considered to be related to the study drug. CONCLUSIONS: The results indicate that GV1001 was effective and well tolerated, and may provide potential beneficial effects in patients with BPH. Compared with medical therapies that require daily dosing, the convenient dosing regimen of GV1001 may provide greater patient adherence. Further investigation of these observations will require large-scale clinical evaluation.

Rapid increase of health care utilization and cost due to benign prostatic hyperplasia in Korean men: retrospective population-based analysis using the Health Insurance Review and Assessment service data.

Using the Korean public health insurance database, we analyzed patients diagnosed as benign prostatic hyperplasia (BPH) from 2004 to 2008. Age and year-specific amount and seasonal variation of hospital visits (HV), duration of treatment (DT), the total and per capita amount of insurance payment (TAIP, PCIP) were evaluated. A total of 12,088,995 HV were studied. Total HV increased 1.7 times and DT almost doubled in 2008 compared to those in 2004. HV, DT, and TAIP showed linearly increasing patterns year by year. In a time series analysis, HV increased in winter and demonstrated seasonality in a 12-month cycle. In a Poisson regression analysis, the annual variations of HV, DT, TAIP, and PCIP were different by age groups. In patients older than 40 yr, HV significantly increased 1.10-1.16 times compared to that of the previous year. DT markedly increased in their 60s and 80s patients. The rate of increase in PCIP was steeper in patients 50 yr and older than in the others.Health care utilization due to BPH was rapidly increasing in Korea and it was remarkable in the elderly population. Seasonal variation of HV demonstrated that health care utilization increased in winter.

Desmopressin add-on therapy for refractory nocturia in men receiving α-blockers for lower urinary tract symptoms.

PURPOSE: Alpha-blockers improve lower urinary tract symptoms associated with benign prostatic obstruction. Nocturia, a storage symptom, is a common complaint in men. However, it does not fully respond to α-blocker therapy, likely due to its multifactorial pathophysiology. We evaluated the efficacy and safety of desmopressin as add-on therapy for refractory nocturia in men previously treated with an α-blocker for lower urinary tract symptoms. MATERIALS AND METHODS: Eligible patients were men 50 years old or older with lower urinary tract symptoms and persistent nocturia despite α-blocker treatment for a minimum of 4 weeks. The optimum dose of oral desmopressin was determined during a 4-week dose titration period and this dose was maintained for 24 weeks. Flow volume charts, International Prostate Symptom Score total and subscores, uroflowmetry and post-void residual urine volume were assessed. RESULTS: A total of 216 patients were enrolled in the study. Of these patients there were 158 (76%) with nocturnal polyuria, 15 (7.2%) with decreased nocturnal bladder capacity and 35 (16.8%) with nocturia due to both causes. The number of nocturnal voids significantly decreased from a baseline mean of 7.0 to 5.7 episodes for 3 days at the 24-week visit. The average International Prostate Symptom Score total and subscore significantly decreased by 4 weeks and were maintained at 24 weeks. In patients younger than 65 years, International Prostate Symptom Score voiding subscores were significantly improved at 24 weeks compared to those age 65 years or older. CONCLUSIONS: Desmopressin add-on therapy for refractory nocturia in men previously treated with an α-blocker for lower urinary tract symptoms improved voiding symptoms as well as nocturia, storage symptoms.

Changes of resistance indices after medication in benign prostatic hyperplasia: a prospective study.

Background: This study aimed to determine the relationship between resistive indices (RIs) and changes in prostate size after medical treatment in patients with benign prostatic hyperplasia (BPH). Methods: A total of 86 patients with BPH were included in the study, excluding 42 patients with a total prostate volume (TPV) of <30 cc or taking α1-adrenergic blockers and 5α-reductase inhibitors (5ARI) before study participation. Therefore, the data for 44 patients were analyzed. All patients were treated with α1-adrenergic blockers and 5ARIs. The variables examined were prostate-specific antigen, International Prostate Symptom Score, quality of life score, maximal urinary flow rate, residual urine volume, TPV, transition zone volume, and RIs of the urethral artery and left and right capsular arteries. These variables were assessed at baseline and after 3 and 6 months of treatment. Results: The mean TPV was 43.5 ± 10.9 and decreased to 35.2 ± 11.5 and 33.9 ± 9.8 after 3 and 6 months of treatment, respectively (p < 0.001). The mean RI of the urethral artery, right capsular artery, and left capsular artery at pretreatment did not decrease significantly. However, comparing the baseline with 3-month data, TPV at 3 months/TPV at baseline was significantly correlated with RI changes in the left capsular artery (r = 758; P < 0.001). Conclusion: In patients with BPH, α1-adrenergic blocker and 5ARI medications for 3 and 6 months did not result in a significant reduction in the RI of the urethral artery and both capsular arteries. Larger scale, prospective studies are needed to evaluate the relationship between TPV and RI reductions.

Current treatment patterns within 1 year after prostate cancer diagnosis in Korean patients over 75 years old: a retrospective multicenter study.

Background: We aimed to evaluate the current status of first-line treatment options for prostate cancer in patients aged ≥75 years in Korea. Materials and methods: The study included 873 patients diagnosed with biopsy-proven prostate cancer at 5 institutions in Korea from January 2009 to December 2018. Inclusion criteria were aged ≥75 years at diagnosis, prostate biopsy with ≥12 cores, and follow-up period ≥1 year. Clinical data were retrospectively collected from electronic medical records. Results: Primary treatment for prostate cancer in patients aged ≥75 years included androgen deprivation therapy (ADT) (n = 614), radical prostatectomy (RP) (n = 114), and radiation therapy (n = 62). Among patients with RP, nine patients received ADT before RP. The RP group was younger with better Eastern Cooperative Oncology Group Performance Status (ECOG PS), lower initial prostate-specific antigen (PSA), Gleason score (GS), max percent positive cores, less positive cores, and less advanced clinical Tumor Node Metastasis (TNM) stage compared with the ADT group. Multivariate analysis showed that age, ECOG PS, and PSA were independent prognostic factors for RP. When the ADT group was classified by therapeutic regimens, the most common therapeutic regimen was maximal androgen blockade (MAB) (n = 571), and leuprolide + bicalutamide (n = 330) was the most common MAB regimen. Multivariate analysis for secondary treatment showed that age, ECOG PS, GS, and clinical N1 or M1 stage were independent predictive factors. Enzalutamide was the most preferred treatment for tertiary treatment. Conclusion: In patients with prostate cancer aged ≥75 years, the most common treatment option was MAB, and the leuprolide + bicalutamide was the most common MAB regimen. Age, ECOG PS, and PSA are the useful indicators of surgical treatment, which increased during the study period. Younger patients with high GS and advanced clinical stage were more likely to undergo secondary treatment.

Optimal duration of preoperative antibiotic treatment prior to ureteroscopic lithotripsy to prevent postoperative systemic inflammatory response syndrome in patients presenting with urolithiasis-induced obstructive acute pyelonephritis.

PURPOSE: There is no consensus on the optimal duration of preoperative antibiotic treatment prior to ureteroscopic lithotripsy in patients presenting with urolithiasis-induced obstructive acute pyelonephritis (APN). We aimed to identify surgeon-modifiable, preoperative risk factors associated with postoperative systemic inflammatory response syndrome (SIRS) in these patients. MATERIALS AND METHODS: This multicenter retrospective study evaluated 115 patients who presented with urolithiasis-induced obstructive APN between January 2008 and December 2019. All patients were administered intravenous third-generation cephalosporin until culture sensitivity confirmation or until ureteroscopic lithotripsy. Data were collected for age, sex, diabetes mellitus, performance status, stone features, hydronephrosis grade, preoperative renal collecting system drainage, laboratory data, operative time, and duration of preoperative antibiotic treatment. Sensitivity analysis using Youden's index and logistic regression analysis were used to assess risk factors of postoperative SIRS. RESULTS: Postoperative SIRS was identified in 32 (27.8%) patients. The incidence of postoperative SIRS was higher in patients who received preoperative antibiotic treatment for fewer than 14 days (38.8% vs. 12.5%; p=0.001). Backward variable selection logistic regression analysis revealed maximal stone diameter ≥15 mm, duration of preoperative antibiotic treatment <14 days, and preoperative C-reactive protein (CRP) level ≥6.0 mg/L to be associated with higher risk of postoperative SIRS. CONCLUSIONS: Patients with urolithiasis-induced obstructive APN planned for ureteroscopic lithotripsy should be administered at least 14 days of preoperative antibiotic administration and achieve a serum CRP level ≤6.0 mg/L to minimize the risk of postoperative SIRS.

Efficacy of adding mirabegron to alpha-adrenoreceptor blocker in patients with benign prostatic hyperplasia with persistent overactive bladder symptoms: A prospective study.

Purpose: To compare the efficacies of mirabegron 50 mg addition after alpha-adrenoreceptor blocker in terms of reducing storage symptoms in patients with BPH. Materials and Methods: Fifty-eight patients that had been taking alpha-adrenoreceptor blocker for more than 8 weeks, but had an OABSS of greater than 3 points, were initially enrolled. One group added any alpha-adrenoreceptor blocker with mirabegron 50 mg (n=39; the mirabegron group) and the other group received alpha-adrenoreceptor blocker only (n=19; the control group) for 8 weeks. Results: In the control group, mean total IPSS decreased from 15.7 to 13.1 (p=0.298) and in mirabegron group, mean total IPSS decreased from 19.4 to 16.5 (p=0.024). Mean storage symptom scores reduced in the control and mirabegron groups from 8.5 to 7.9 (p=0.584) and from 9.1 to 7.6 (p=0.015), respectively, and mean QoL scores from 3.7 to 3.1 (p=0.052) and 3.6 to 3.2 (p=0.027), respectively. Mean overall OABSS in the control and mirabegron groups reduced from 8.4 to 7.2 (p=0.173) and from 8.8 to 7.3, respectively (p=0.005); mean OABSS Q3 from 3.6 to 2.9 (p=0.073) and from 3.5 to 2.7 (p=0.002), respectively; and mean OABSS Q4 from 2.4 to 2.0 (p=0.306) and from 2.7 to 2.0 (p=0.016), respectively. The change of mean Qmax and PVR was insignificant in 2 groups. Conclusions: IPSS total scores, storage symptom scores, QoL, overall OABSS, OABSS Q3 and Q4 were more improved significantly by alpha-adrenoreceptor blocker with mirabegron 50 mg in BPH patients with persistent overactive symptoms. Mirabegron 50 mg addition is considered to patients with persistent storage symptoms after alpha-adrenoreceptor blocker.

Comparison of the Effect of Naftopidil 75 mg and Tamsulosin 0.2 mg on the Bladder Storage Symptom With Benign Prostatic Hyperplasia: Prospective, Multi-institutional Study.

OBJECTIVE: To compare the efficacies of naftopidil and tamsulosin in terms of reducing storage symptoms in patients with benign prostatic hyperplasia. MATERIALS AND METHODS: This prospective randomized study was performed at 10 centers. Ninety-four patients that had been taking tamsulosin for more than 8 weeks, but had an Overactive Bladder Symptom Score (OABSS) of greater than 3 points, were initially enrolled. After a 1-week washout period, patients were divided into 2 groups. Forty-five patients were treated with tamsulosin 0.2 mg daily, and 49 patients were treated with naftopidil 75 mg daily for 8 weeks. Total International Prostate Symptoms Score (IPSS), storage symptom scores, nocturia times, OABSS, maximal flow rates (Qmax), and postvoid residual volumes were checked before and after the 8-week treatment period. RESULTS: Mean patient ages in the tamsulosin and naftopidil groups were 64.8 and 66.0 years, respectively. Baseline characteristics were not significantly different. In the tamsulosin group, mean total IPSS decreased from 19.1 to 15.1 after the 8-week treated period (P = .001), and in the naftopidil group, mean total IPSS decreased from 16.9 to 13.1 (P = .001). Mean storage symptom scores were reduced in the tamsulosin and naftopidil groups from 8.0 to 6.6 (P = .002) and from 7.6 to 6.1 (P = .001), respectively. Mean nocturia times in the naftopidil groups decreased significantly from 2.5 to 1.9 (P = .001), and mean OABSSs were reduced from 7.7 to 6.0 (P = .001) and from 7.4 to 6.0 (P = .001), respectively. CONCLUSION: Total IPSS, storage symptom scores, nocturia times, and OABSS were significantly reduced by naftopidil and tamsulosin. Moreover, the naftopidil group showed better improvements in nocturia than the tamsulosin group.

Changes in autonomic nervous system activity after treatment with alpha-blocker in men with lower urinary tract symptoms.

Purpose: To determine changes in autonomic nervous system activity after treatment in men with lower urinary tract symptoms (LUTS), we evaluated changes in patients' symptoms, uroflowmetry, and heart rate variability (HRV) after treatment with alpha-blockers for 12 weeks. Materials and Methods: Ninety-five men who had LUTS (International Prostate Symptom Score [IPSS] ≥8) were included in this study. We divided them into two groups on the basis of a low frequency/high frequency (LF/HF) ratio of 1.6. After treatment with Xatral XL (Handok Inc., Korea) 10 mg for 3 months, we rechecked their IPSS, uroflowmetry, HRV and compared these with the baseline measurements. Results: Fifty-four men were assigned to the low LF/HF group (group A: LF/HF ≤1.6) and 41 men to the high LF/HF group (group B: LF/HF >1.6). At baseline and 12 weeks, none of the parameters differed significantly between the groups except for HF, which is one of the parameters of HRV. IPSS, the IPSS-voiding subscore, and the IPSS-storage subscore decreased and maximal uroflow increased significantly after 12 weeks of treatment. Whereas the baseline LF/HF ratio increased from 0.89±0.407 to 1.80±1.804 after treatment in group A, it decreased from 3.93±5.471 to 1.79±1.153 in group B. Conclusions: The efficacies of Xatral XL were clear in both groups. We found that the LF/HF ratio in the two groups merged to a value of approximately 1.79 after treatment. We suggest that this could be a clue to the importance of balance in autonomic nervous system activity in men with LUTS.

The Correlation between Body Mass Index and Routine Parameters in Men Over Fifty.

PURPOSE: This study aimed to investigate the relationships between body mass index (BMI) and prostate-specific antigen (PSA) levels, international prostate symptom score (IPSS), quality of life (QoL), and prostate volume (PV). MATERIALS AND METHODS: Height, weight, PSA levels, PV, and IPSS were analyzed in 15,435 patients who underwent a prostate examination between 2001 and 2014. Patients aged <50 years or with a PSA level ≥10 ng/mL were excluded. The relationships between BMI and PSA, IPSS, QoL, and PV were analyzed by a scatter plot, one-way analysis of variance, and the Pearson correlation coefficient. RESULTS: The mean age was 71.95±7.63 years, the mean BMI was 23.59±3.08 kg/m², the mean PSA level was 1.45±1.45 ng/mL, the mean IPSS was 15.53±8.31, the mean QoL score was 3.48±1.25, and the mean PV was 29.72±14.02 mL. PSA, IPSS, and QoL showed a tendency to decrease with increasing BMI, and there were statistically significant differences for each parameter (p≤0.001). PV showed a significant tendency to increase with BMI (p<0.001). In the correlation analysis, BMI showed a statistically significant correlation (p<0.001) with PSA, IPSS, and QoL, although the correlations were very weak. In contrast, BMI showed a significant correlation with PV (p<0.001), with a meaningful Pearson correlation coefficient of 0.124. CONCLUSIONS: Higher BMI was associated with lower PSA levels and higher IPSS and QoL scores. Meanwhile, PV increased with BMI. Although obese individuals had a greater PV, obesity did not aggravate lower urinary tract symptoms.

Clinical Significance of the Resistive Index of Prostatic Blood Flow According to Prostate Size in Benign Prostatic Hyperplasia.

PURPOSE: The authors evaluated the relationships between the clinical factors and resistive indexes (RIs) of prostate and urethral blood flows by using power Doppler transrectal ultrasonography (PDUS) in men with benign prostatic hyperplasia (BPH). METHODS: The data of 110 patients with BPH and lower urinary tract symptoms (LUTS) treated between January 2015 and July 2015 were prospectively collected. PDUS was used to identify the capsular and urethral arteries of the prostate in order to measure RIs. International Prostate Symptom Score (IPSS), maximal flow rate (Qmax), total prostate volume (TPV), transition zone volume (TZV), transition zone index (=TZV/TPV), presence of intravesical prostatic protrusion (IPP), and the RIs of capsular and urethral arteries were evaluated for all of the patients by one urologist. RESULTS: The 110 patients were categorized according to IPSS (mild symptoms, 0-7; moderate symptoms, 8-19; and severe symptoms, 20-35), Qmax (<10 and ≥10 mL/sec), TPV (<30 and ≥30 mL), and presence or absence of IPP. No significant relationship was found between the mean RI of any artery and IPSS or Qmax. The mean RIs of the urethral artery, and left and right capsular arteries were significantly dependent on prostate size and the presence of IPP. CONCLUSIONS: RI obtained by using PDUS correlated with the presence of IPP and prostate size. The RI of prostate blood flow can be used as a noninvasive diagnostic tool for BPH with LUTS.

Risk factors for hypertensive attack during pheochromocytoma resection.

PURPOSE: We aimed to retrospectively evaluate the risk factors for hypertensive attack during adrenalectomy in patients with pheochromocytoma. Despite the development of newer surgical and anesthetic techniques for the management of pheochromocytoma, intraoperative hypertensive attack continues to present a challenge. MATERIALS AND METHODS: Data from 53 patients diagnosed with pheochromocytoma at Kyungpook National Uriversity Medical Center between January 2000 and June 2012 were retrospectively analyzed. The subjects were divided into 2 groups depending on the presence or absence of hypertensive attack at the time of surgery. Patient demographic characteristics and preoperative evaluations were assessed for their prognostic relevance with respect to hypertensive attack. A univariate analysis was conducted, and a multivariate logistic regression analysis was also performed. RESULTS: In the univariate analysis, systolic blood pressure at presentation, preoperative hormonal status (including epinephrine, norepinephrine, vanillylmandelic acid, and metanephrine levels in a 24-hour urine sample), tumor size, and postoperative systolic blood pressure were significantly associated with the development of hypertensive attack. In the multivariate analysis, preoperative epinephrine level and tumor size were independent factors that predicted hypertensive attack. The highest odds ratio for tumor size (2.169) was obtained at a cutoff value of 4.25 cm and the highest odds ratio for preoperative epinephrine (1.020) was obtained at a cutoff value of 166.3 µg/d. CONCLUSIONS: In this study, a large tumor size and an elevated preoperative urinary epinephrine level were risk factors for intraoperative hypertensive attack in patients with pheochromocytoma.

Alpha-Blocker Treatment Response in Men With Lower Urinary Tract Symptoms Based on Sympathetic Activity: Prospective, Multicenter, Open-Labeled, Observational Study.

PURPOSE: In this study, we compared the treatment outcomes for an α-blocker between 2 groups of men, one with high sympathetic activity (HSA) and another with low sympathetic activity (LSA) or normal sympathetic activity. METHODS: A total of 159 men (≥50 years of age) with lower urinary tract symptoms resulting from benign prostatic hyperplasia were analyzed. We assigned patients to groups according to their sympathetic activity, which was evaluated by heart ratevariability measurements. HSA was defined as a low frequency/high frequency ratio greater than 1.6. All patients received 10mg of alfuzosin once a day for 12 weeks. The primary end point was a change in the total International Prostate SymptomScore (IPSS) at 12 weeks from baseline. RESULTS: Sixty-seven men were assigned to the HSA group and 92 men were assigned to the LSA group. The baseline characteristics were not significantly different between the 2 groups, and the response to alfuzosin was good in both groups. Themean total IPSS change was not different between the groups. Both groups were not significantly different with respect to the changes in maximal flow rate, IPSS voiding or storage symptom subscores, quality of life, and rates of adverse drug events. TheHSA group showed a similar willingness to continue treatment compared to the LSA group, although their treatment satisfaction rating was lower. CONCLUSIONS: The therapeutic effects of alfuzosin did not differ in regards to the differences in sympathetic activity, but treatment satisfaction ratings were lower in the HSA group.

A new strategy for the diagnosis of MAGE-expressing cancers.

The expression of melanoma antigen gene (MAGE), coding for tumor antigens recognized by cytotoxic T cell, is highly specific to cancer cells, but their use in the detection of a few cancer cells by reverse transcription-polymerase chain reaction (RT-PCR) has been limited by the low frequency of expression of individual MAGE genes. In order to increase MAGE detection rate in RT-PCR assay, here, we designed multiple MAGEs recognizing primers (MMRPs) that can bind to the sequences of cDNA of MAGE-1, -2, -3, -4a, -4b, -5a, -5b and-6 (MAGE 1-6) together. The nested RT-PCR assay using MMRPs, MAGE 1-6 assay, detected MAGE messages of 1 to 5 SNU484 cells in a background of 10(7) SNU638 cells. MAGE detection rate of MAGE 1-6 assay in cancers was higher than that of nested RT-PCR that detects single MAGE gene expression. The expressions of MAGE genes was detected by MAGE 1-6 assay in 70.4% (19/27) of head and neck cancer tissues, 91.7% (11/12) of breast cancer tissues, 75% (9/12) of lung cancer tissues. However, they were not detected in 18 benign lesions and 20 normal head and neck tissues and 30 blood samples from healthy donor. In conclusions, MAGE 1-6 assay can detect any cancer cells that express at least one of eight MAGE subtype genes, and this method may be very useful for the diagnosis of MAGE-expressing cancers.

Efficacy of Bicalutamide 150-mg Monotherapy Compared With Combined Androgen Blockade in Patients With Locally Advanced Prostate Cancer.

PURPOSE: We compared the efficacy, survival rate, and adverse events between bicalutamide 150-mg monotherapy and combined androgen blockade (CAB) in men with locally advanced prostate cancer. MATERIALS AND METHODS: From March 2003 to July 2012, we retrospectively included 74 patients who were treated for more than 3 months and were followed up for more than 6 months. 25 men were treated with bicalutamide 150-mg only (group 1) and 49 men received CAB (group 2). Serum prostate-specific antigen (PSA) change, survival rate, and adverse events were compared between the 2 groups. RESULTS: The PSA levels before and after treatment were 37.0±32.8 ng/mL and 9.5±27.0 ng/mL in group 1 (p<0.001) and 50.2±40.0 ng/mL and 20.0±35.8 ng/mL in group 2 (p<0.001). Mean survival rates were 78.9% in group 1 and 52.3% in group 2 (p=0.055). There were no statistically significant differences in adverse events between the 2 groups (p=0.304). The International Index of Erectile Function 5 (IIEF-5) score before treatment was 19.3±5.9 in group 1 and 18.3±5.8 in group 2 (p=0.487). The IIEF-5 score after treatment was 17.1±6.3 in group 1 and 14.0±6.1 in group 2, which was a statistically significant difference (p=0.036). CONCLUSIONS: The PSA change, mean survival rate, and adverse events in patients with locally advanced prostate cancer treated with bicalutamide 150-mg and CAB did not differ significantly. However, sexual function was better in the bicalutamide 150-mg group. Therefore, bicalutamide 150-mg monotherapy could be considered as a treatment for locally advanced prostate cancer in patients concerned about sexual function.

Vesicoenteric fistula due to bladder squamous cell carcinoma.

Vesicoenteric fistula is a rare complication of bladder squamous cell carcinoma. We report the case of a 70-year-old male who complained of painless, total gross hematuria. Abdominopelvic computed tomography (CT) revealed an approximately 2.7-cm lobulated and contoured enhancing mass in the bladder dome. We performed partial cystectomy of the bladder dome after transurethral resection of the bladder. The biopsy result was bladder squamous cell carcinoma, with infiltrating serosa histopathologically, but the resection margin was free. Postoperatively, follow-up CT was done after 3 months. Follow-up CT revealed an approximately 4.7-cm×4.0-cm lobulated, contoured, and heterogeneous mass in the bladder dome. A vesicoenteric fistula was visible by cystography. Here we report this case of a vesicoenteric fistula due to bladder squamous cell carcinoma.

Clinicopathologic differences between prostate cancers detected during initial and repeat transrectal ultrasound-guided biopsy in Korea.

PURPOSE: The aim of this study was to investigate clinicopathologic differences between prostate cancer (PCa) detected at initial and repeat transrectal ultrasound-guided prostate biopsy in a large Korean cohort. MATERIALS AND METHODS: From 2000 through 2012, a total of 7,001 patients underwent transrectal ultrasound-guided prostate biopsy at 6 centers in Daegu and Gyeongbuk provinces. Of these 7,001 patients, the initial biopsy was positive for PCa in 2,118 patients. Repeat biopsy was performed in 374 of the 4,883 patients with an initial negative finding and a persistently elevated prostate-specific antigen (PSA) level, nodules or asymmetry by digital rectal examination (DRE), high-grade prostatic intraepithelial neoplasia, or atypical small acinar proliferation. Numbers of biopsy cores varied from 6 to 12 according to center and biopsy date. RESULTS: Cancer was diagnosed in 2,118 of the 7,001 patients (30.3%) at initial biopsy and in 86 of the 374 patients (23.0%) at repeat biopsy. The repeat biopsy rate was 5.3%. Mean PSA values were 68.7±289.5 ng/mL at initial biopsy and 18.0±55.4 ng/mL at repeat biopsy (p<0.001). The mean number of cancer-positive cores per biopsy was 5.5±3.5 for initial biopsy and 3.0±2.9 for repeat biopsy (p<0.001). Mean Gleason score was 7.5±1.4 at initial biopsy and 6.6±1.3 at repeat biopsy (p<0.001). For detected cancers, the low-stage rate was higher for repeat biopsy than for initial biopsy (p=0.001). CONCLUSIONS: Cancers detected at repeat biopsy tend to have lower Gleason scores and stages than cancers detected at initial biopsy. The present study shows that repeat biopsy is needed in patients with a persistently high PSA or abnormal DRE findings.

BAI, a novel Cdk inhibitor, enhances farnesyltransferase inhibitor LB42708-mediated apoptosis in renal carcinoma cells through the downregulation of Bcl-2 and c-FLIP (L).

Previously, we reported the potential of a novel Cdk inhibitor, 2-[1,1'-biphenyl]-4-yl-N-[5-(1,1-dioxo-1λ6-isothiazolidin-2-yl)-1H-indazol-3-yl]acetamide (BAI) as a cancer chemotherapeutic agent. In this study, we investigated mechanisms by which BAI modulates FTI-mediated apoptosis in human renal carcinoma Caki cells. BAI synergizes with FTI to activate DEVDase, cleavage of poly ADP-ribose polymerase (PARP), and degradation of various anti-apoptotic proteins in Caki cells. BAI plus LB42708-induced apoptosis was inhibited by pretreatment with pan-caspase inhibitor, z-VAD-fmk, but not by overexpression of CrmA. The ROS scavenger, N-acetylcysteine (NAC) did not reduce BAI plus LB4270-induced apoptosis. Co-treatment of BAI and LB42708 reduced the mitochondrial membrane potential (MMP, ∆Ψm) in a time-dependent manner, and induced release of AIF and cytochrome c from mitochondria in Caki cells. Furthermore, BAL plus LB42708 induced downregulation of anti-apoptotic proteins [c-FLIP (L), c-FLIP (s), Bcl-2, XIAP, and Mcl-1 (L)]. Especially, we found that BAI plus LB42708-induced apoptosis was significantly attenuated by overexpression of Bcl-2 and partially blocked by overexpression of c-FLIP (L). Taken together, our results show that the activity of BAI plus LB42708 modulate multiple components in apoptotic response of human renal Caki cells, and indicate a potential as combinational therapeutic agents for preventing cancer such as renal carcinoma.

Effect of Transurethral Resection of the Prostate on Storage Symptoms in Patients with Benign Prostatic Hyperplasia of Less than 30 ml.

PURPOSE: Many patients with benign prostatic hyperplasia (BPH) have not only voiding symptoms but also storage symptoms. Despite the many types of treatment that have been developed for BPH, storage symptoms persist. We conducted an assessment of the efficacy of transurethral resection of the prostate (TURP) and the change in the International Prostate Symptoms Score (IPSS) storage sub-score after the procedure according to prostate size in patients with BPH. MATERIALS AND METHODS: Men aged 50 years or older who had BPH were enrolled in this study. 186 patients were divided into two groups according to prostate size measuring using transrectal ultrasonography: In group 1, prostate size was less than 30 ml (51 patients), and in group 2, prostate size was greater than 30 ml (135 patients). All of the patients underwent TURP. We examined whether the degree of change in the IPSS, voiding symptoms, storage symptoms, and quality of life (QoL) differed before and after TURP and according to prostate size. RESULTS: After three months of TURP, the subjects in both groups showed significant improvement in the IPSS, voiding symptoms, storage symptoms, QoL, and maximum flow rate (p<0.05). The scores for the IPSS, voiding symptoms, storage symptoms, and QoL of group 1 and 2 after three months of TURP were 16.36, 14.25 (p=0.233), 8.21, 8.24 (p=0.980), 8.11, 5.16 (p=0.014), 2.89, and 2.10 (p=0.030), respectively. CONCLUSIONS: TURP is an effective treatment for patients with BPH, regardless of prostate size. However, while the improvement in the storage symptoms of patients with a prostate size of less than 30 ml was not significant, it was in patients with a prostate size greater than 30 ml.

Malacoplakia of the epididymis.

Malacoplakia is a chronic inflammatory disease. The disease mainly affects the urinary bladder, although involvement of extravesical sites is increasingly being documented. Most frequently involved is the urinary tract, particularly the urinary bladder, although the testis, epididymis, lungs, bone, colon, prostate, female genital organs, and retroperitoneum can also be involved. Here we report the case of a 61-year-old man with a scrotal mass with histology that was specific for malacoplakia of the epididymis. The histologic workup demonstrated extensive involvement of the epididymis by diffuse infiltrates of large histiocytes with eosinophilic granular cytoplasm and numerous Michaelis-Gutmann bodies, which were diagnostic of malakoplakia. This is the first case of epididymal malacoplakia in our country and the first case of epididymal malacoplakia without concurrent involvement of the testis. There have been few reports of this condition worldwide.