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Novel androgen receptor axis-targeted agents (ARATAs) have been developed for mCRPC and improved overall survival (OS). Here, we aimed to find predictors who will receive the greatest benefits from ARATAs.We previously performed a multicenter study to identify prognostic factors for metastatic hormone-sensitive prostate cancer (mHSPC, n = 148) and mCRPC (n = 99), and showed that the bone scan index (BSI) was one of the significant prognostic factors for 3-year OS (PROSTAT-BSI study). mHSPC progressed to mCRPC (n = 101), for which 69 patients were treated with (n = 39) or without ARATAs (n = 30, prior to the approval of ARATAs). The 69 patients were divided into two groups according to patient factors, and these cohorts were further divided into two subgroups by usage of ARATAs. OS was compared between subgroups in each group.The predictors were age (71.4 years), serum levels of C-reactive protein (≥0.16 ng/ml) and alkaline phosphatase (≥548 U/L), time to PSA progression after ADT (8.9 months), the lowest PSA level (≥1 ng/ml) after ADT, and the rate of PSA decline 3 months after ADT (0.987), whereas hemoglobin levels, PSA before ADT, Gleason scores, existence of visceral metastases, and BSI were not.The present study identified predictors for the effectiveness of ARATAs. The number of bone metastases (≒BSI), existence of visceral metastases, and Gleason scores, which were identified as high-risk factors in the LATITUDE study and disease volume in CHAARTED criteria, did not appear to be useful for predicting effectiveness from ARATAs.

OBJECTIVE To assess the efficacy of silodosin as second-line α-blocker monotherapy in patients with lower urinary tract symptoms as a result of benign prostatic hyperplasia. METHODS Men who were given an α-blocker other than silodosin for ≥8 weeks, aged ≥50 years, had a total International Prostate Symptom Score ≥13 and quality of life index ≥4 were enrolled. After treatment with 8 mg/day silodosin for 8 weeks, symptoms and treatment satisfaction were assessed. If the patients still complained and hoped for readministration of the first-line α-blocker, the previous medication was administered again for 8 weeks in the case of persisting symptoms, and efficacy was again evaluated. RESULTS A total of 73 patients were enrolled and analyzed at 8 weeks. Silodosin administration significantly improved the International Prostate Symptom Score and Overactive Bladder Symptom Score. The quality of life index was improved by at least 1 point in 49.3% patients, and its mean change was significantly greater in the group with previous naftopidil treatment than in those with tamsulosin. A total of 59 patients hoped to continue silodosin, and 13 requested administration of the first-line α-blocker. Previously taking naftopidil and having a shorter duration of prior α-blocker treatment at baseline were associated with silodosin continuation. Although prior α-blocker readministration in the 13 patients did not show significant efficacy, six preferred to continue the previous α-blocker. CONCLUSIONS Silodosin represents an effective second-line α-blocker monotherapy, even in those who still have moderate lower urinary tract symptoms.

Objective: To present the study design and rationale of Prostatic Cancer Registry of Standard Hormonal and Chemotherapy Using Bone Scan Index, a prospective study aiming to determine the role of the bone scan index, the amount of bone metastasis, in the treatment and prognosis of prostate cancer patients. Methods: A total of 237 patients were recruited at 30 hospitals in Japan. All had prostate cancer with bone metastasis and were scheduled to undergo either hormonal therapy (group H) or chemotherapy (group C). Bone scans were carried out with (99m)Tc-methylenediphosphonate. Follow-up studies are planned to continue for 3 years, and changes in biochemical and tumor markers in response to hormonal therapy and chemotherapy will be recorded in addition to skeletal-related events, recurrence, disease progression and death. Results: The basic characteristics of the patients (n = 200) at the time of registration during December 2016 were as follows: mean age 71 ± 8 years; median bone scan index calculated on-site 1.9% (range 0.02–13.3%); median number of hot spots 18 (range 1–128); median prostate-specific antigen 155 ng/mL (range 0.04–22 412 ng/mL); and the most frequent Gleason score 9 (47%). The prostate-specific antigen value was higher in group H than group C (288 vs 33 ng/mL, P < 0.0001), whereas bone scan indexes were comparable (1.7 vs 2.3%, not significant) between the two groups. Liver metastasis was more frequent in group C than group H (6.1% vs 0.8%, P = 0.035). Conclusions: The baseline characteristics of the Prostatic Cancer Registry of Standard Hormonal and Chemotherapy Using Bone Scan Index database have been established. This collaborative study can now proceed with clarifying the role of the bone scan index for patient management including treatment strategies and prognosis.

Objective To comprehensively analyze the 5-year outcomes of tamsulosin treatment for patients with benign prostatic hyperplasia. Methods Tamsulosin (0.2 mg/day) was given to 112 patients who had International Prostate Symptom Scores ≥8. They were prospectively followed for 5 years with periodic evaluation. If tamsulosin had to be discontinued, the reason was determined. Treatment failure was considered in the case of disease progression (postvoid residual urine volume ≥200 mL, acute urinary retention, febrile urinary tract infection or hydronephrosis as a result of bladder outlet obstruction), conversion to other α1-blockers or need for surgery. An intention-to-treat analysis was carried out. Results A total of 34 patients (30.4%) continued the same medication for the overall study period, whereas 78 patients (69.6%) discontinued the medication. International Prostate Symptom Scores, Benign Prostatic Hyperplasia Problem Index and Quality of Life Index were significantly improved over the 5-year period. Treatment failure was observed in 21 patients (18.8%). Baseline prostate volume and postvoid residual urine volume were independent factors to predicting treatment failure. A total of 21 patients (18.8%) discontinued tamsulosin because of an improvement of symptoms. They were younger and had lower prostate-specific antigen levels than the remaining 91 patients. Their symptoms were stable even 1 year after termination of therapy. Conclusions Long-term efficacy of tamsulosin was observed, although only a small portion of patients continued the treatment. α1-blocker monotherapy might be not appropriate for achieving a good long-term outcome in patients with a large prostate volume and a large amount of postvoid residual urine volume. Persistent improvement of symptoms, even after termination of tamsulosin, was observed in young patients with low prostate-specific antigen levels.

Objective: To investigate the incidence of renal cell carcinoma, classified by sex, age group and region in Japan, following a 5-year interval after a previous survey performed in 1997. Methods: The survey was conducted between the beginning of January 2002 and the end of December 2002. A total of 1288 institutions in all 47 prefectures throughout Japan were requested to register cases. Results: There were 7405 persons with renal cell carcinoma, consisting of 5063 males and 2342 females. Crude incidence rates were 8.2 and 3.6 per 100 000 population for men and women, respectively. Incidence rates in the Hokkaido region were highest followed by the Shikoku region. Conclusions: Despite incidence of renal cell carcinoma increasing to 7405 from the 6358 persons in 1997, statistical data reported by the Ministry of Health, Labor and Welfare indicate that rising age-adjusted death rate for this tumor reached a ceiling in the past decade. Early detection may have contributed to this current trend; however, further epidemiological research is required to fully elucidate this.

Objective: A joint study was undertaken by the Japanese Society of Renal Cancer to investigate the present status of partial nephrectomy in Japan and to speculate about what may be the indications for partial nephrectomy in patients with renal cell carcinoma. Methods: Data were tabulated for 469 patients from participating medical institutions and various clinical factors were investigated with regard to disease progression (local recurrence and distant metastasis). Results: Disease progression was observed in 21 patients (4.5%). No significant relation to disease progression was observed for sex, laterality, tumor histology, grade and tumor size. Although patients with solitary tumors displayed excellent prognosis irrespective of tumor diameter, patients with multiple tumors displayed a high likelihood of disease progression. Patients older than 77 years old and patients with imperative indication were found to have a poorer prognosis. Conclusion: In patients with solitary tumors, partial nephrectomy can be actively performed, even if the patient displays elective indications and the tumor is >4 cm in diameter. In patients displaying multiple tumors with imperative indications, the decision whether to perform partial nephrectomy should be made by the patients and their physicians after considering the impact on curability and the quality of life.

Background: Our previous study showed that the growth rate of incidentally found renal cell carcinoma (RCC) varied, and that the initial clinical and pathological features did not predict subsequent growth of the carcinoma. The objective of this study was to determine the relationships between cell proliferation, apoptosis, angiogenesis and the growth rates of these RCC. Methods: We examined cell proliferation, apoptosis, and angiogenesis in 16 incidentally found cases of RCC. Cell proliferation was assessed by immunohistochemical staining with a Ki-67 antibody. Apoptosis was assessed by the terminal deoxynucleotidyl transferase (TdT) mediated deoxy-UTP biotin nick end labeling (TUNEL) technique. The Ki-67 labeling index (KI) and the apoptotic index (AI) were determined as the ratio of immunohistochemically positive cells per 1000 cancer cells. The KI/AI ratio was also determined. Angiogenesis was evaluated by CD34 immunostaining. Finally, we investigated the correlation between these parameters and the growth rate of primary lesions of incidentally found RCC. Results: The KI ranged from 7 to 73 (median, 20), AI ranged from 6 to 171 (median, 26), and microvessel density (MVD) ranged from 21 to 673 (median, 265) for incidentally found RCC. Ki-67 labeling index, AI and MVD were not closely correlated to each other. Furthermore, these parameters were not associated with growth rates of incidentally found RCC. Only the KI/AI ratio was strongly correlated to the growth rate of incidentally found RCC (r = 0.709; P = 0.0083). Conclusion : Our results suggest that the balance between cell proliferation and apoptosis partly determines the growth rate of primary lesions of incidentally found RCC.

Background: The natural history and growth rate of renal cell carcinoma (RCC) have not yet been determined. The growth rates of primary lesions in incidentally found RCC were compared with those of metastatic lesions. Methods: Sixteen patients who did not receive immediate surgical treatment for renal solid masses that were later proven to be RCC were reviewed retrospectively. All primary lesions of the 16 patients were found incidentally. For comparison, metastatic lesions were evaluated in another 16 patients with RCC. Of these, 11 underwent surgical treatment for the primary lesions. Results: The growth rates of primary and metastatic lesions of RCC varied. They ranged from 0.10 to 1.35 cm/year for primary lesions and from 0.08 to 7.87 cm/year for metastatic lesions. The growth rate of primary lesions of incidentally found RCC was lower than that of metastatic lesions (P = 0.0159). The initial tumor diameter and pathological grade did not affect the growth rate of the primary lesion of incidentally found RCC. However, a close correlation was found between the growth rate of metastatic lesions and the pathological grade of the primary lesion in patients with metastasis. Conclusions: The growth rate of incidentally found RCC varied. Some patients with the disease may be candidates for ‘watchful waiting’ when an immediate surgical treatment is not indicated, but they should be selected with great caution.

Background: To compare the QOL in patients with ileal or colon conduits (IC), continent urinary reservoir (CR) and ileal neobladder (NB), a retrospective study was conducted using a question- naire sent by mail. Methods: Seventy-nine patients with a mean age of 60 years were included in this study. A total of 36, 22 and 21 underwent IC, CR and NB, respectively and were alive at the time of this study. A structured questionnaire consisting of 97 questions that covered general condition and physical condition, reconstruction-related symptoms, psychological status, sexual life, social status and satisfaction with the treatment was employed. Results: The IC group frequently complained of changes in bathing habits and loss of using public baths in comparison with the CR and the NB groups. High scores for loss of sexual desire were obtained in the IC, the CR and the NB groups, in this order. Because of the nearly physiological voiding, the NB group desired a voiding condition like pre-operative status as compared with the IC and the CR groups. However, for most of the questionnaire items no difference was seen among the IC, CR and NB groups concerning general condition, reconstruction-related symptoms, psy- chological status, sexual life, social status, satisfaction with the treatment and global satisfaction with life and health. Conclusions: There was little difference in the QOL score of the questionnaire and satisfaction among the IC, CR and NB groups. It was suggested that almost every patient accepted and adapted to the present status of general quality of life in each group.

Background: Angiomyofibroblastoma is a relatively recently described rare tumor of the superficial soft tissues. To date, 57 cases of angiomyofibroblastoma of the external genitalia in women have been reported. Methods/Results: We describe a case of a 24-year-old woman who presented with the urinary stream flowing out in the posterior direction and whose diagnosis was a urethral tumor, angiomyofibroblastoma. Conclusions: Angiomyofibroblastoma has a potential arising from the female urethra as well as other areas of the external genitalia.