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Objectives: To report long-term outcome survival analysis of docetaxel-based chemotherapy combined with dexamethasone in castration-resistant prostate cancer patients (Japan-Multinational Trial Organization Pca10-01 trial)., Methods: The Japan-Multinational Trial Organization Pca10-01 phase II trial was a multicenter, prospective single-arm, phase II trial both in non-metastatic and metastatic castration-resistant prostate cancer patients that was organized by The Japan-Multinational Trial Organization. Patients received 75 mg/m 2 of docetaxel (every 21 days) and 0.5 mg of dexamethasone orally twice a day continuing throughout the treatment period. The primary end-point of this additional analysis was overall survival. Secondary end-points were progression-free survival and safety., Results: Between January 2011 and February 2014, a total of 76 chemotherapy-naïve castration-resistant prostate cancer patients were enrolled. The median overall survival time was 42.5 months. The median overall survival time of M1 patients was 40.5 months (M0: not reached). The median progression-free survival time was 13.2 months (M0: 15.7 months and M1: 12.3 months). The multivariate analysis predicting overall survival of M1 patients showed that time to castration-resistant prostate cancer (≥20 months) was an independent parameter (hazard ratio 0.39, P = 0.023). Regarding the safety analysis, 36 out of 74 patients (48.6%) suffered from any grade of adverse events after the protocol treatment, and 18 patients (24.3%) had grade ≥3 adverse events., Conclusions: Docetaxel-based chemotherapy combined with dexamethasone can achieve excellent survival efficacy not only in M0 castration-resistant prostate cancer patients, but also in M1 castration-resistant prostate cancer patients., (© 2019 The Japanese Urological Association.)

Objectives: Our aim was to clarify the risk factors of cancer death in order to reduce mortality from T1 bladder cancer., Methods: The Japan registration database (1999-2001) was used for the analysis. Data were collected at least 3years after the initial diagnosis. Cause-specific survival using a Kaplan-Meier survival estimation with the log-rank method was evaluated. Univariate and multivariate analysis using the Cox proportional hazard model was also carried out. The 1997 TNM classification was used for pathological staging, and the 1973 WHO classification was used for pathological grading., Results: There were 76 cancer deaths among a total of 1919 clinical T1 cases. Regardless of the subsequent treatment strategies, non-papillary tumor appearance, non-peduncular tumor stalk, multiple tumors, a tumor size greater than 3cm, positive urinary cytology and pathological grade 3 were found to be statistically significant in cancer death by univariate analysis. By multivariate analysis, non-papillary tumor appearance, positive urinary cytology and a tumor size greater than 3cm were confirmed as significant risk factors. Cancer death cases were found in 47.4% of worst-grade 2 tumors, and in 67.1% of predominantly grade 1 or 2 tumors., Conclusion: Non-papillary tumor appearance, positive urinary cytology and a tumor size greater than 3cm should be included to enable the assessment of risk criteria in cancer death from T1 bladder cancer., (© 2010 The Japanese Urological Association.)

Objective: To characterize the clinical outcome in a large contemporary series of Japanese patients with newly diagnosed Ta, T1 non-muscle invasive bladder cancer who underwent transurethral bladder tumor resection with or without intravesical chemotherapy or Bacillus Calmette-Guérin (BCG) therapy., Methods: We developed a database incorporating newly diagnosed non-muscle invasive bladder cancer data and outcomes from a Japanese bladder cancer registry between 1999 and 2001 and identified a study population of 3237 consecutive patients who had complete data based on pathological features. Median patient age was 69.9 years., Results: The 1-year, 3-year, and 5-year overall recurrence-free survival rates were 77.0%, 61.3%, and 52.8%, respectively. In multivariate analyses, the multiplicity of bladder tumors, tumor size greater than 3 cm, pathological stage T1, tumor grade G3, and the absence of adjuvant intravesical instillation were independent risk factors for tumor recurrence. Overall, 1710 patients (52.8%) received intravesical instillation; chemotherapy in 1314 (76.8%) and BCG treatment in 396 (23.2%). In patients treated with intravesical chemotherapy in which an anthracycline chemo-agent was used in 90.5% of the cases, multivariate analyses demonstrated that male gender, multiple bladder tumors, a tumor size greater than 3 cm, and pathological stage T1 were associated with tumor recurrence., Conclusions: The accumulation and analysis of data from the Japanese National Bladder Cancer Registry made it possible to determine the clinical characteristics, management trends, and survival rates for the period studied. Further study with a dataset created from longer follow-up data would be warranted to analyze tumor progression and disease survival.

Objectives: It is generally recognized that cigarette smoking is the most important risk factor for bladder cancer. The present study was undertaken to examine the relationships between smoking history of bladder cancer patients and the age of onset of bladder cancer and tumor characteristics., Methods: The present study examined the data for 5959 cases (4728 males and 1231 females) collected in the bladder cancer database of the Japanese Urological Association from 1999 to 2001. Patients were divided by smoking history into three categories as current non-smokers, current smokers and unknown smoking history. Relationship between smoking history and the age at diagnosis of bladder cancer, gender, T stage, grade, tumor size, tumor number and initial symptoms was analyzed., Results: In both males and females the onset of bladder cancer is about 6 years (6.1 years in males and 5.9 years in females) earlier for current smokers than for current non-smokers. At the time of diagnosis, tumor stage was significantly higher in the current smokers group. The current smokers group tended to have larger tumor size., Conclusions: The finding of 6-year-earlier onset of bladder cancer among current smokers is of great importance to both health care and medical economics. It is essential to make people better informed concerning the need to quit smoking.

Objective: To evaluate the prognosis of our series of patients with renal cell carcinoma (RCC) and tumor thrombus involving inferior vena cava (IVC) treated with nephrectomy and thrombectomy., Methods: In 46 patients with unilateral RCC extending into IVC who underwent nephrectomy and thrombectomy (T3b in 38 patients, T3c in 6, T4 in 2, N+ in 15, M1 in 21), overall and cancer-specific survival rates were estimated, and the univariable and multivariable analysis were carried out to determine the prognostic factors among age, gender, performance status, fever, inflammatory laboratory parameters, nodal and distant metastasis, tumor thrombus level, pathological parameters and postoperative interferon-alpha administration., Results: The median age was 66.5 (range 35-79) years. The median follow-up was 18.0 (mean 36.7 +/- 38.7) months. The overall and cancer-specific 5-year survival rates were 32.9% and 40.0%, respectively. The univariate analysis revealed that fever (hazard ratio: HR 4.03), C-reactive protein (HR 4.89), grade of tumor cell (HR 3.83), and lymph node metastasis (HR 5.99) were independent prognostic factors of cause-specific survival in all patients. The multivariate analysis demonstrated that lymph node metastasis (HR 4.13) was the only independent prognostic factor of cause-specific survival. The extension level or postoperative interferon-alpha administration did not influence the prognosis of patients with tumor thrombus involving IVC., Conclusions: Aggressive surgery should be considered first in RCC patients with any levels of tumor thrombus. However, patients with both IVC involvement and nodal metastasis showed significantly poor prognosis, and development of novel intensive multidisciplinary therapies will be needed.

Objectives: To assess the relationship between the tissue levels of pyrimidine nucleoside phosphorylase (PyNpase) and clinicopathological parameters in human bladder cancer and to investigate the PyNpase levels in rat and mouse urinary bladder initiated by N-butyl-N-(4-hydroxybutyl) nitrosamine (BBN)., Methods: The PyNpase levels in tumor tissue, normal tissue adjacent to the tumor, and normal tissue apart from the tumor were measured in 102 patients. Additionally, the PyNpase levels were measured in rat and mouse urinary bladders treated with BBN., Result: The PyNpase levels of tumor tissue significantly correlated to the tumor grade and growth pattern (papillary/non-papillary), while stage, multiplicity, and tumor shape (peduncle/sessile) were not independent factors. The low-risk tumor of primary, single, G1-Ta showed significantly low levels of PyNpase. The PyNpase levels in the tumor tissue were significantly higher than those in the normal tissue. The PyNpase levels in the adjacent normal tissue were significantly higher than those in the distant normal tissue. The PyNpase levels in rat bladder tissue were significantly higher in the BBN-treatment groups than in those in the control group, only during the early carcinogenic stage. The PyNpase levels in mouse bladder tissue were significantly higher in BBN-treatment groups than in those in the control group during the whole experiment period., Conclusion: Our results indicated that not only tumor tissue but also normal tissue adjacent to the tumor had a potential of angiogenesis for tumor development, and transurethral resection of the bladder tumor with a wide normal margin seems to be a reasonable strategy for decreasing the risk of recurrence.

We report a rare case of chromophobe cell renal carcinoma found in a 52-year-old female who had received hemodialysis therapy for 13 years. She was diagnosed as having a left renal tumor 7.5 cm in diameter with acquired cystic disease of the kidney (ACDK) by ultrasonographic examination during periodical systemic screening. As abdominal computed tomography scanning and enhanced color Doppler ultrasonography suspected that the hypervascular tumor was renal cell carcinoma, she underwent translumbar nephrectomy in July 2000. The histopathological diagnosis was chromophobe cell carcinoma with pT2 and grade 2 malignancy. Chromophobe cell carcinoma is uncommon among renal tumors with ACDK found in long-term hemodialysis patients.

Objectives: Transurethral needle ablation of the prostate is a new alternative endoscopic thermal therapy that uses a low-energy radio frequency delivered into the prostatic adenoma. Herein is reported the initial clinical experience by multiple institutes in Japan of transurethral needle ablation of the prostate for the treatment of symptomatic benign prostatic hyperplasia., Methods: A total of 93 patients were treated with this technique. Transurethral needle ablation of the prostate was generally performed under low-spinal anesthesia. Before and after the procedure, international symptom score (IPSS), quality of life (QOL) score, peak urinary flow rate (Qmax), postvoid residual urine volume and prostate size were evaluated., Results: There was a reduction of IPSS of more than 50% when compared with that of pretreatment, being 51.3% (57/93 patients) and 60.2% (56/93 patients) at 3 months and 6 months after the procedure, respectively. Sixty-seven patients who were available for a 12-month follow-up period demonstrated a markedly decreased mean IPSS when compared with that measured before the treatment for a statistically significant difference (P < 0.01). Fifty-eight patients who were available for uroflowmetric study at 12 months exhibited a notably increased mean Qmax of 11.2 +/- 4.5 mL/s, which was a statistically significant increase when compared with that found before treatment (P < 0.05). Although all patients suffered some degree of gross hematuria after the procedure, none of them required any specific treatment for complications., Conclusion: Transurethral needle ablation technique for the treatment of symptomatic benign prostatic hyperplasia is safe and effective. However, a much longer follow-up study is essential for fully evaluating the extended effectiveness of this technique.

Background: New diagnostic criteria for dynamic magnetic resonance (MR) imaging in prostate cancer are presented. The diagnostic usefulness of endorectal MR imaging with dynamic contrast-enhancement in localized prostate cancer and the validity of these criteria were evaluated., Methods: Eighteen untreated patients who were suspected of localized prostate cancer were included in the study. They received endorectal dynamic MR imaging before systematic sextant needle biopsy. First. a mapping study with the findings of MR images and histopathology of biopsy specimens was performed in eight patients out of 18 to compare the difference in T2-weighted images with the endorectal coil and the body coil in the same individuals. Second, another mapping study was performed in all 18 patients by analyzing the findings of endorectal dynamic MR images. For the diagnosis of prostate cancer in MR imaging, we offered diagnostic criteria from our experience in addition to those in plain T2-weighted images from the literature., Results: The overall diagnostic rates of endorectal dynamic MR imaging were 88.9% in accuracy, 100% in sensitivity, and 81.8% in specificity. In the comparison of the endorectal and body coils in T2-weighted images in eight patients, there was no difference in the diagnostic rates except for one more histopathologic false positive portion in endorectal MR imaging. In the second mapping study in 18 patients, the diagnostic rates were 92.6% in accuracy, 88.9% in sensitivity and 93.3% in specificity. Endorectal dynamic imaging raised the diagnostic sensitivity from 77.8 to 88.9%., Conclusion: The data demonstrated the validity of this diagnostic criteria and the diagnostic usefulness of endorectal dynamic MR imaging in localized prostate cancer.

Background: The prevalence of lower urinary tract symptoms was determined by survey as an initial step in estimating the significance of benign prostatic hyperplasia (BPH) in Asia and Australia., Methods: The symptom index (0 to 35) and quality-of-life (QOL) index (0 to 6) of the international prostate symptom score were measured in 7588 men in 9 Asian countries and 146 men in Australia., Results: The percentages of Asian men considered to be symptomatic (symptom index > or = 8) were 18%, 29%, 40%, and 56% in the age groups of 40 to 49, 50 to 59, 60 to 69, and 70 to 79 years, respectively. For Australian men, these figures were 36%, 33%, and 37% in the 50 to 59, 60 to 69, and 70 to 79 year age groups, respectively., Conclusions: Our estimates indicate that the prevalences of symptomatic men in Asia and Australia are similar to or greater than those in Europe and America, and suggest BPH is similarly common in these areas.

Background: Standard severity criteria for benign prostatic hyperplasia (BPH) are needed to facilitate clinical and epidemiologic investigations in the common terminology., Patients and Methods: A total of 692 BPH patients from 8 institutions were judged by specialized physicians for their overall disease severity and severity in 4 domains: symptom, function, anatomy, and quality of life (QOL). The items measuring severity in these 4 domains were the International Prostate Symptom Score (I-PSS) questionnaire, uroflowmetry, transrectal ultrasonography (TRUS), and questionnaires on bother and I-PSS QOL index, respectively. By Spearman's rank correlation and multiple regression analysis using physicians' judgement as the criterion variable (gold standard) the items and their cut-off levels were selected so that high predictivity, practicality and clinical significance were maintained, while the number of items in use was minimized., Results: The item(s) and their ranges of values for each severity grade were summarized as follows; the evaluation domain (the selected item(s): range of mild, moderate, severe): symptom (I-PSS: 0-7, 8-19, 20-35), function (maximum flow rate and residual urine volume: > or = 15 mL/s and < 50 mL, > or = 5 mL/s and < 100 mL, < 5 mL/s or > or = 100 mL), anatomy (prostate volume on TRUS: < 20 mL, < 50 mL, > or = 50 mL), QOL (QOL index: 0 and 1, 2 to 4, 5 and 6). The overall severity was efficiently predicted when defined according to the combinations of severity grades of the 4 domains. These criteria predicted physicians' judgement with accuracy of about 80% for overall severity and severity of individual domains., Conclusion: The proposed criteria are valid, practical, and would be useful for the common scale of the BPH severity in clinical and epidemiologic studies.

Background: Various treatment modalities for benign prostatic hyperplasia (BPH) have emerged and are now in use or await evaluation of clinical usefulness. It is difficult, however, to compare their efficacies on a single scale, because standardized criteria for therapeutic efficacy of BPH treatments have not been established., Patients and Methods: A total of 692 BPH patients from 8 institutions in Japan received various treatments, and were judged by specialized physicians for overall efficacy, and for efficacy in 4 domains: symptom, function, anatomy, and quality of life (QOL). Efficacy of treatment was graded as excellent, good, fair or poor, and assessed using items based on conventional clinical measurements. These items included 1) the difference (post-pretreatment value), 2) relative ratio (post/pre) and, 3) the individual values of pre- or posttreatment measurements. The cut off levels for each grade were heuristically selected by Spearman's rank correlation and multiple regression analysis so that the results accurately predicted physicians' judgement, while the feasibility was maintained., Results: The results for each efficacy grade (range of excellent, range of good, range of fair, range of poor) were summarized as follows: Symptom: (post/pre treatment ratio of I-PSS) < or = 0.25, < or = 0.5, < or = 0.75, > 0.75. Function: (post-pre of Qmax) > or = 10 mL/s, > or = 5 mL/s, > or = 0.25 mL/s, < 0.25 mL/s. Anatomy: (post/pre ratio of prostate volume) < or = 0.5, < or = 0.75, < or = 0.9, > 0.9. QOL: (pre-post of QOL index) > or = 4, 3, 2 and 1, < or = 0. The overall efficacy grade was defined as the median of efficacy grades of 3 domains: symptom, function and QOL. The agreement rates between the criteria and physicians' judgement on the dichotomous efficacy (either excellent plus good, or fair plus poor) were approximately 80% in individual domains and overall estimate, and consistent among various treatments., Conclusion: The proposed criteria are fairly accurate, simple, and practical, and thus may be useful as a standard method for assessing the clinical efficacy of BPH treatments.

Background: Ejaculatory dysfunction is a substantial obstacle for spinal cord-injured men who have a desire to father their own children. Electroejaculation can potentially solve this problem. Recently, Halsted et al. reported outstanding results of the rectal probe electrostimulation (RPE) using newly developed equipment (Seager Model). In this paper, we report the first large-scale clinical trial in Japan of RPE for spinal cord-injured men., Methods: RPE using the Seager Model was attempted on 328 occasions in 53 patients with an age range of 19-47 years; 1-38 years had elapsed since injury., Results: Antegrade ejaculation was obtained in 46 patients (86.8%). Ninety-three percent of patients with upper motor neuron lesion-type neurogenic bladder produced antegrade ejaculation by RPE, whereas the rate in patients with lower motor neuron lesion type one was 63.6% (P < 0.05). Semen analyses revealed affected sperm motility rate as low as 17.2%. Artificial insemination from these husbands (AIH) was attempted on 54 occasions in 11 wives of the patients. On April 2, 1992, we had the first recorded birth in Japan with the assistance of RPE and AIH. On July 21, 1993, we had another successful birth., Conclusions: These promising results will encourage Japanese researchers to use electro-ejaculation, although the low success rate in patients with lower motor neuron lesion-type neurogenic bladder and the low motility of the sperm are obstacles to be overcome.