31 results on '"Shiota, Masaki"'
Search Results
2. Survival beyond cabazitaxel for metastatic castration-resistant prostate cancer.
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Blas L, Shiota M, Tanegashima T, Kobayashi S, Matsumoto T, and Eto M
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- Humans, Male, Antineoplastic Agents therapeutic use, Neoplasm Metastasis, Prostatic Neoplasms, Castration-Resistant drug therapy, Prostatic Neoplasms, Castration-Resistant pathology, Prostatic Neoplasms, Castration-Resistant mortality, Taxoids therapeutic use
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- 2024
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3. Validation study on the 2 mm diameter cutoff in lymph node-positive cases following radical prostatectomy in accordance with the AJCC/UICC TNM 8th edition: Real-world data analysis from a Japanese cohort.
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Kato M, Shiota M, Kimura T, Hanazawa R, Hirakawa A, Takamatsu D, Tashiro K, Matsui Y, Hashine K, Saito R, Yokomizo A, Yamamoto Y, Narita S, Hashimoto K, Matsumoto H, Akamatsu S, Nishiyama N, Eto M, Kitamura H, and Tsuzuki T
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- Humans, Male, Aged, Middle Aged, Retrospective Studies, Japan, Neoplasm Micrometastasis pathology, Prognosis, East Asian People, Prostatectomy methods, Prostatic Neoplasms surgery, Prostatic Neoplasms pathology, Prostatic Neoplasms mortality, Lymphatic Metastasis pathology, Neoplasm Staging, Lymph Node Excision methods, Lymph Nodes pathology, Lymph Nodes surgery
- Abstract
Objectives: The American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) 8th edition has proposed micrometastasis as a lymph node metastasis (LN+) of diameter ≤2 mm in prostate cancer. However, supporting evidence has not described. We evaluated LN+ patients' survival after radical prostatectomy (RP) based on the LN maximum tumor diameter (MTD)., Methods: Data from 561 LN+ patients after RP and pelvic LN dissection (PLND) treated between 2006 and 2019 at 33 institutions were retrospectively investigated. Patients were stratified by a LN+ MTD cutoff of 2 mm. Outcomes included castration resistance-free survival (CRFS), metastasis-free survival (MFS), cancer-specific survival (CSS), and overall survival (OS)., Results: In total, 282 patients were divided into two groups (LN+ MTD >2 mm [n = 206] and ≤2 mm [n = 76]). Patients of LN+ status >2 mm exhibited significantly decreased CRFS and MFS, and poorer CSS and OS. No patients developed CRPC in the LN+ status ≤2 mm group when the PLND number was ≥14. Multivariate analysis showed the number of LN removed, RP Gleason pattern 5, and MTD in LN+ significantly predicted CRFS., Conclusions: Patients of LN+ status ≤2 mm showed better prognoses after RP. In all the patients in the ≤2-mm group, the progression to CRPC could be prevented with appropriate interventions, particularly when PLND is performed accurately. Our findings support the utility of the pN substaging proposed by the AJCC/UICC 8th edition; this will facilitate precision medicine for patients with advanced prostate cancer., (© 2024 The Japanese Urological Association.)
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- 2024
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4. Validation of schedules for optimal prostate-specific antigen monitoring after radical prostatectomy.
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Blas L, Shiota M, Tanegashima T, Tsukahara S, Ueda S, Mutaguchi J, Goto S, Kobayashi S, Matsumoto T, Inokuchi J, and Eto M
- Subjects
- Humans, Male, Neoplasm Recurrence, Local pathology, Prostatectomy adverse effects, Retrospective Studies, Prostate-Specific Antigen, Prostatic Neoplasms pathology
- Abstract
Background: Early detection of biochemical recurrence (BCR) after radical prostatectomy (RP) is crucial for early treatment and improving survival outcomes. The optimal prostate-specific antigen (PSA) monitoring remains unclear, and several models have been proposed. We aimed to externally validate four models for optimal PSA monitoring after RP and propose modifications to improve them., Methods: We reviewed the clinicopathological data of 896 patients who underwent robot-assisted RP between 2009 and 2022. We examined all PSA values and estimated the PSA value for four monitoring schedules at each time point in the virtual follow-up. We defined the ideal PSA for BCR detection between 0.2 and 0.4 ng/mL., Results: During the median follow-up of 21.4 months, 128 (14.3%) patients presented BCR. The original and modified Keio models, National Cancer Center Hospital model, and American Urological Association/American Society for Radiation Oncology model detected BCR in 14 (10.9%), three (2.3%), 12 (9.4%), and 11 (8.6%) patients with PSA >0.4 ng/mL. Most patients experienced BCR detected with PSA >0.4 ng/mL during the first year postoperative. The modification of interval within 6 months postoperative avoided BCR detection with PSA >0.4 ng/mL within the first year postoperative in 8/9 (88.9%), 1/2 (50.0%), 5/6 (83.3%), and 4/4 (100%) for the original and modified Keio models, National Cancer Center Hospital model, and American Urological Association/American Society for Radiation Oncology model, respectively., Conclusion: We validated four models for PSA monitoring after RP to detect BCR and suggested modifications to avoid detections out of the desired range of PSA. These modifications could help to establish an optimal PSA monitoring schedule after RP., (© 2023 The Japanese Urological Association.)
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- 2024
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5. Clinical features and oncological outcomes of bladder cancer microsatellite instability.
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Nagakawa S, Shiota M, Takamatsu D, Tsukahara S, Mastumoto T, Blas L, Inokuchi J, Oda Y, and Eto M
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- Humans, BCG Vaccine therapeutic use, Microsatellite Instability, Adjuvants, Immunologic, Administration, Intravesical, Neoplasm Invasiveness pathology, Neoplasm Recurrence, Local epidemiology, Neoplasm Recurrence, Local genetics, Neoplasm Recurrence, Local drug therapy, Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms therapy, Urinary Bladder Neoplasms drug therapy
- Abstract
Objectives: Excellent anticancer effect for solid tumors with microsatellite instability (MSI)-high by anti-PD-1 antibody has been reported. In this study, we investigated the clinical impact of MSI status in bladder cancer., Methods: This study included 205 Japanese patients who underwent transurethral resection for bladder cancer between 2005 and 2021. The prevalence rates of microsatellite stable (MSS), MSI-low (MSI-L), and MSI-high (MSI-H) were determined using molecular testing. We examined the association of MSI status (MSS versus MSI-L/H) with clinicopathological characteristics and oncological outcomes., Results: MSI-L/H tumors were associated with higher T-category in non-muscle invasive bladder cancer (NMIBC). Additionally, MSI-L/H tumors were associated with a higher risk of intravesical recurrence in NMIBC patients treated with intravesical bacillus Calmette-Guérin (BCG) but not with non-BCG therapy., Conclusions: This study suggested that the MSI status might serve as a predictive marker for intravesical recurrence after BCG intravesical therapy in NMIBC and highlighted an unmet need for an alternative treatment in patients with MSI-L/H tumors., (© 2024 The Japanese Urological Association.)
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- 2024
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6. GnRH antagonist monotherapy versus a GnRH agonist plus bicalutamide for advanced hormone-sensitive prostate cancer; KYUCOG-1401.
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Yokomizo A, Shiota M, Morokuma F, Eto M, Matsuyama H, Matsumoto H, Kamoto T, Terada N, Kawahara K, Enokida H, Tatarano S, Fujimoto N, Higasijima K, Sakai H, Hakariya T, Igawa T, Suekane S, Kamba T, Sugiyama Y, Kishimoto J, and Naito S
- Subjects
- Male, Humans, Androgen Antagonists adverse effects, Antineoplastic Combined Chemotherapy Protocols, Anilides adverse effects, Nitriles adverse effects, Tosyl Compounds adverse effects, Gonadotropin-Releasing Hormone, Lipids therapeutic use, Prostate-Specific Antigen, Prostatic Neoplasms
- Abstract
Objectives: To compare the effectiveness and safety of gonadotropin-releasing hormone (GnRH) antagonist monotherapy to combined androgen blockade (CAB) with a GnRH agonist and bicalutamide in patients with advanced hormone-sensitive prostate cancer (HSPC)., Methods: The study was conducted as KYUCOG-1401 trial (UMIN000014243) and enrolled 200 patients who were randomly assigned to either group A (GnRH antagonist monotherapy followed by the addition of bicalutamide) or group B (CAB by a GnRH agonist and bicalutamide). The primary endpoint was PSA progression-free survival. The secondary endpoints were the time to CAB treatment failure, radiographic progression-free survival, overall survival, changes in serum parameters, including PSA, hormones, and bone and lipid metabolic markers, and adverse events., Results: PSA progression-free survival was significantly longer in group B (hazard ratio [HR], 95% confidence interval [CI]; 1.40, 1.01-1.95, p = 0.041). The time to CAB treatment failure was slightly longer in group A (HR, 95% CI; 0.80, 0.59-1.08, p = 0.146). No significant differences were observed in radiographic progression-free survival or overall survival. The percentage of patients with serum testosterone that did not reach the castration level was higher at 60 weeks (p = 0.046) in group A. No significant differences were noted in the serum levels of bone metabolic or lipid markers between the two groups. An injection site reaction was more frequent in group A., Conclusions: The present results support the potential of CAB using a GnRH agonist and bicalutamide as a more effective treatment for advanced HSPC than GnRH antagonist monotherapy., (© 2023 The Japanese Urological Association.)
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- 2024
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7. Differential cancer-specific survival with curative radiotherapy to the prostate for metastatic prostate cancer according to estimated survival by risk group.
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Shiota M, Terada N, Kimura T, Kitamura H, Kamoto T, and Eto M
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- Male, Humans, Prostate-Specific Antigen, Prostate pathology, Prostatic Neoplasms pathology
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- 2023
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8. Bone-modifying agents are protective for symptomatic skeletal events in Radium-223 treatment.
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Blas L, Shiota M, Matsumoto T, Hori Y, Nakamura M, Seki N, Kuroiwa K, Yokomizo A, Morokuma F, Kiyoshima K, and Eto M
- Subjects
- Male, Humans, Radioisotopes adverse effects, Radium therapeutic use, Prostatic Neoplasms, Castration-Resistant radiotherapy, Bone Neoplasms drug therapy
- Abstract
Introduction: Radium-223 (Ra-223) dichloride therapy increases overall survival and delays time to the first symptomatic skeletal event (SSE) in patients with castration-resistant prostate cancer (CRPC) and bone metastases. Bone-modifying agents (BMA) reduce SSE in patients with bone metastasis, but there is little information on their use with Ra-223. This study aimed to investigate the effect of BMA on SSE in patients with bone metastatic CRPC treated with Ra-223 in real-world practice., Methods: We included 73 patients treated with Ra-223 from 10 institutions in Japan. Time to the first SSE was estimated using the Kaplan-Meier method and compared between groups using the log-rank test. We used univariate analysis to ascertain the association between variables and SSE., Results: During a median follow-up of 12.7 months (interquartile range, 7-21.7), 12 (16.4%) patients presented SSE. Age and BMA use were different between men with and without SSE. The 1-year SSE-free survival rate from Ra-223 treatment initiation was 82.4% (95% CI, 69.4%-90.2%). BMA use was associated with favorable SSE-free survival (hazard risk, 0.23; 95% confidence interval, 0.061-0.85; p = 0.027). Two (4.7%) and seven (23.3%) patients presented symptomatic pathological bone fracture in groups with and without BMA use, respectively (p = 0.017)., Conclusion: This study stresses the importance of BMA use in patients with CRPC and bone metastases in Ra-223 treatment., (© 2023 The Japanese Urological Association.)
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- 2023
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9. Clinical factors for tumor response, progression, and survival in nivolumab for advanced renal cell carcinoma in the SNiP-RCC study.
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Blas L, Shiota M, Miyake H, Takahashi M, Oya M, Tsuchiya N, Masumori N, Matsuyama H, Obara W, Shinohara N, Fujimoto K, Nozawa M, Ohba K, Ohyama C, Hashine K, Akamatsu S, Kamba T, Mita K, Gotoh M, Tatarano S, Fujisawa M, Tomita Y, Mukai S, Ito K, Tanegashima T, Tokunaga S, and Eto M
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- Humans, Male, Middle Aged, Aged, Female, Nivolumab adverse effects, Immune Checkpoint Inhibitors therapeutic use, Polymorphism, Single Nucleotide, Carcinoma, Renal Cell pathology, Kidney Neoplasms pathology
- Abstract
Background: This study is part of the SNPs in Nivolumab PD-1 inhibitor for RCC (SNiP-RCC). Here we aimed to reveal clinical factors for tumor response, progression, and survival in nivolumab for advanced clear cell renal cell carcinoma (RCC) in Japanese patients., Methods: We included patients from 23 institutions in Japan. We evaluated the objective response, radiographic progression-free survival (PFS), overall survival (OS), and treatment-related grade ≥ 3 (serious adverse events [SAEs])., Results: We included 222 patients. The median age was 69 years (interquartile range 62-74 years), and 71% of the patients were male. Pancreas metastasis, lung metastases, prior cytokine therapy, and SAEs, were associated with objective response. The median PFS was 18 months. Liver metastases (hazard ratio [HR], 1.61), age ≥ 75 (HR, 0.48), previous resection of primary sites (HR, 0.47), and SAEs (HR, 0.47) were independent prognostic factors for PFS. Karnofsky Performance Status <70 (HR, 2.90), high platelets (HR, 4.48), previous resection of primary sites (HR, 0.23), and pathological grade (HR, 0.19 for grade 2 and HR, 0.12 for grade 3) were independent prognostic factors for OS. SAEs were reported in 45 (20.3%) cases. In the group of patients with prior nephrectomy, SAEs were associated with objective response, PFS, and OS., Conclusion: The SNiP-RCC study identified clinical parameters correlated with treatment outcomes in Japanese patients with priorly treated advanced clear cell RCC undergoing nivolumab monotherapy., (© 2023 The Japanese Urological Association.)
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- 2023
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10. Fusion-targeted biopsy significantly improves prostate cancer detection in biopsy-naïve men.
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Blas L, Shiota M, Tsukahara S, Goto S, Kinoshita F, Matsumoto T, Monji K, Kashiwagi E, Inokuchi J, and Eto M
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- Male, Humans, Biopsy methods, Image-Guided Biopsy methods, Magnetic Resonance Imaging methods, Pelvis pathology, Retrospective Studies, Prostate diagnostic imaging, Prostate pathology, Prostatic Neoplasms diagnostic imaging, Prostatic Neoplasms pathology
- Abstract
Objective: The precise diagnosis of prostate cancer (PC) is crucial to avoid underdiagnosis, overdiagnosis, and overtreatment. We aimed to compare clinically significant PC (csPC) detection between MRI/ultrasound fusion-targeted prostate (TBx) compared to systematic biopsy (SBx) in biopsy-naïve Japanese men., Methods: We included patients with suspect PC due to elevated PSA level or abnormal digital rectal examination, or both. csPC was defined as International Society Urological Pathology (ISUP) grade group ≥2 (csPC-A) and ISUP grade group ≥3 (csPC-B)., Results: This study included 143 patients. Overall PC detection was 66.4% for SBx and 67.8% for MRI-TBx. MRI-TBx presented a significantly higher rate of csPC detection (csPC-A 67.1% vs. 58.7%, p = 0.04, and csPC-B 49.6% vs. 39.9%, p < 0.001) and significantly lower detection of non-csPC-A (0.6% vs. 6.7%). Importantly, MRI-TBx missed 4.9% (7/143) of csPC-A and only 0.7% (1/143) of csPC-B. On the other hand, SBx alone missed 13.3% (19/143) of csPC-A and 4.2% (6/143) of csPC-B., Conclusion: MRI-TBx significantly outperformed 12-cores SBx for csPC detection and decreased non-csPC detection in biopsy-naive men. Performing MRI-TBx without SBx would have missed some csPC, supporting that MRI-TBx synergizes with SBx to increase csPC detection., (© 2023 The Japanese Urological Association.)
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- 2023
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11. Correlation between extended pelvic lymph node dissection and urinary incontinence at early phase after robot-assisted radical prostatectomy.
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Lee K, Shiota M, Takamatsu D, Ushijima M, Blas L, Okabe A, Kajioka S, Goto S, Kinoshita F, Matsumoto T, Monji K, Kashiwagi E, Inokuchi J, Oda Y, and Eto M
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- Male, Humans, Prostate surgery, Prostate pathology, Synaptophysin, Lymph Node Excision adverse effects, Prostatectomy adverse effects, Polyesters, Robotics, Prostatic Neoplasms pathology, Robotic Surgical Procedures adverse effects, Urinary Incontinence epidemiology, Urinary Incontinence etiology
- Abstract
Objectives: To investigate the impact of extended pelvic lymph node dissection (ePLND) on urinary incontinence (UI) at early post-surgery robot-assisted radical prostatectomy (RARP)., Methods: Patients who underwent RARP without cavernous nerve sparing were included between 2014 and 2019. Patient data were obtained prospectively. The associations between ePLND and postoperative urinary continence were defined as a maximum of one daily pad use. International prostate symptom score (IPSS) was examined. Expression of synaptophysin and tyrosine hydroxylase (TH) in perilymph node adipose tissue (PLA) was evaluated by immunohistochemistry., Results: In total, 186 and 163 patients underwent RARP with and without ePLND. Urinary continence rate at 1 month postoperatively among patients with ePLND was lower than those without ePLND (24.1% vs. 35.1%, p < 0.05), however, not significantly different at 3, 6, and 12 months after RARP (57.4 vs. 62.6%, 73.1 vs. 74.2%, and 83.0 vs. 81.2%, respectively). Total and voiding plus postvoiding IPSS scores at 1 month were higher in patients with ePLND than in those without ePLND (14.5 ± 0.5 vs. 13.6 ± 0.6, 7.0 ± 0.3 vs. 6.2 ± 0.4, respectively, p < 0.05). In univariate and multivariate analyses, larger prostate volume and ePLND were factors associated with an increased UI rate. Among patients who underwent ePLND, synaptophysin and TH-positive nerve fibers were detected in PLA., Conclusions: Detection of synaptophysin and TH-immunopositive nerves suggested denervation of sympathetic and peripheral nerves caused by ePLND might be associated with a higher UI rate and poor urinary symptoms at an early stage after RARP., (© 2022 The Japanese Urological Association.)
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- 2023
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12. Effectiveness and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and bone metastases in real-world practice: A multi-institutional study.
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Matsumoto T, Hori Y, Shiota M, Blas L, Nakamura M, Seki N, Kuroiwa K, Yokomizo A, Morokuma F, Kiyoshima K, and Eto M
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- Male, Humans, Female, Retrospective Studies, Pain, Treatment Outcome, Radium adverse effects, Prostatic Neoplasms, Castration-Resistant drug therapy, Bone Neoplasms radiotherapy, Bone Neoplasms drug therapy, Anemia chemically induced, Anemia drug therapy
- Abstract
Objective: Radium-223 (Ra-223) dichloride is the bone-targeted radioligand therapy that prolongs overall survival (OS) in patients with bone-metastatic castration-resistant prostate cancer (CRPC). We aimed to evaluate the safety and effectiveness of this treatment in real-world practice., Methods: We included Japanese men treated with Ra-223 for bone-metastatic CRPC from 10 institutions, retrospectively. Primary endpoint was OS. Secondary endpoint was maximum decline of alkaline phosphatase (ALP), lactate dehydrogenase, and prostate-specific antigen values, the rate of adverse events, and time to pathological fracture after Ra-223 treatment. Exploratory endpoint was the associations between clinical parameters and OS., Results: In total, 73 men with bone metastatic CRPC treated with Ra-223 were enrolled. The median OS was 20.9 months. ALP levels decreased significantly from pre-treatment (p = 0.03). Anemia occurred in three (4.1%) patients. Grade ≥ 3 non-pathological fractures occurred in four (5.5%) men. Nine (12.3%) patients presented pathological fracture; 7/30 (23.3%) were in men without concomitant use of a bone-modifying agent (BMA) while 2/43 (4.7%) were in patients with concomitant BMA (p = 0.03). The median OS in patients with ≥3 cycles treatment (27.2 months, p < 0.001) or hemoglobin ≥12 g/dl (27.2 months, p = 0.001) or absence of bone pain (36.3 months, p = 0.004) was significantly longer compared to those who with ≤2 cycles or hemoglobin<12 g/dl or presence of bone paint, respectively., Conclusions: This study has shown the outcomes of Ra-223 treatment in real-world practice, where the number of treatment cycles, baseline anemia and bone pain may be useful to predict OS in Ra-223 treatment., (© 2022 The Japanese Urological Association.)
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- 2023
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13. Testosterone level in seminal vesicle fluid is a better indicator of erectile function than serum testosterone in patients with prostate cancer.
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Kashiwagi E, Shiota M, Naganuma H, Monji K, Imada K, Lee K, Matsumoto T, Takeuchi A, Inokuchi J, and Eto M
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- Aged, Deoxyguanosine, Dinoprostone, Humans, Male, Middle Aged, Prostatectomy methods, Seminal Vesicles, Sperm Motility, Testosterone, Transforming Growth Factor beta1, Zinc, Erectile Dysfunction etiology, Erectile Dysfunction surgery, Prostatic Neoplasms surgery
- Abstract
Objectives: Semen comprises prostatic fluid and seminal vesicle fluid, and seminal vesicle fluid contains various factors such as prostaglandin E2 (PGE2), zinc, and testosterone, which play important roles in sperm motility. It is not known whether these factors affect erectile function. In this study, we investigated factors in seminal vesicle fluid that may affect erectile function., Methods: After receiving institutional review board approval, we collected seminal vesicle fluid samples from 134 Japanese patients with localized prostate cancer who underwent robot-assisted radical prostatectomy. We examined the relationship between the results of the Sexual Health Inventory for Men (SHIM), erection hardness score, an original questionnaire on the presence or absence of sexual desire, and concentrations of several factors in seminal vesicle fluid (testosterone, PGE2, transforming growth factor β1, and 8-hydroxy-2-deoxyguanosine), as well as the serum testosterone level., Results: Median participant age was 67 (range 51-77) years. Median concentrations were as follows: seminal vesicle testosterone 1.85 (range 0.17-4.32) ng/ml and serum testosterone 4.60 (range 1.75-10.82) ng/ml. When the SHIM score was divided into two groups, seminal vesicle testosterone concentration was significantly increased (p = 0.002) in participants with a SHIM score ≥17, and no significant difference was observed in serum testosterone levels (p = 0.661). Multivariate analysis revealed that seminal vesicle testosterone was significantly correlated with the SHIM score (≥17 vs. <17; odds ratio 2.137, 95% confidence interval 1.148-3.978, p = 0.016)., Conclusions: Testosterone levels in seminal vesicle fluid can reflect erectile function in patients with prostate cancer, suggesting that seminal vesicle testosterone is very important for male erectile function., (© 2022 The Japanese Urological Association.)
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- 2022
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14. Cancer-specific and net overall survival in older patients with de novo metastatic prostate cancer initially treated with androgen deprivation therapy.
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Narita S, Terada N, Nomura K, Sakamoto S, Hatakeyama S, Kato T, Matsui Y, Inokuchi J, Yokomizo A, Tabata KI, Shiota M, Kimura T, Kojima T, Inoue T, Mizowaki T, Sugimoto M, Kitamura H, Kamoto T, Nishiyama H, and Habuchi T
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- Aged, Androgen Antagonists therapeutic use, Androgens, Humans, Male, Proportional Hazards Models, Retrospective Studies, Prostatic Neoplasms pathology
- Abstract
Objective: This study aimed to assess survival outcomes in older patients with de novo metastatic prostate cancer who initially received androgen deprivation therapy., Methods: The retrospective multicenter study included 2784 men with metastatic prostate cancer who were treated with androgen deprivation therapy between 2008 and 2017. Patients were classified into <75, 75-79, and ≥80 age groups. Propensity score matching was conducted to assess the cancer-specific survival of the groups. The 5-year net overall survival of each group was derived to evaluate relative survival compared with the general population using the Pohar-Perme estimator and the 2019 Japan Life Table., Results: During the follow-up (median, 34 months), 1014 patients died, of which 807 died from metastatic prostate cancer progression. Compared with the <75 group, the cancer-specific survival of the 75-79 group was similar (hazard ratio 1.07; 95% confidence interval 0.84-1.37; P = 0.580), whereas that of the ≥80 group was significantly worse (hazard ratio 1.41; 95% confidence interval 1.10-1.80; P = 0.006). The 5-year net overall survival of the <75, 75-79, and ≥80 age groups were 0.678, 0761, and 0.718, respectively. The 5-year net overall survival of patients aged ≥80 years with low- and high-volume disease were 0.893 and 0.586, respectively, which was comparable with those in patients aged <75 years (0.872 and 0.586, respectively)., Conclusions: Older metastatic prostate cancer patients aged ≥80 years had poorer cancer-specific survival compared with younger patients. Conversely, 5-year net overall survival in older patients aged ≥80 years was comparable with that in younger patients aged <75 years., (© 2022 The Japanese Urological Association.)
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- 2022
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15. Impact of nerve sparing in robot-assisted radical prostatectomy on the risk of positive surgical margin and biochemical recurrence.
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Komori H, Blas L, Shiota M, Takamatsu D, Matsumoto T, Lee K, Monji K, Kashiwagi E, Inokuchi J, and Eto M
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- Humans, Male, Margins of Excision, Prostate innervation, Prostate surgery, Prostate-Specific Antigen, Prostatectomy adverse effects, Prostatectomy methods, Robotic Surgical Procedures adverse effects, Robotic Surgical Procedures methods, Robotics, Urogenital Abnormalities surgery
- Abstract
Objectives: Nerve sparing may increase positive surgical margin rate during radical prostatectomy. Our objective was to analyze the positive surgical margin rate and location as well as its impact on biochemical recurrence according to nerve sparing procedure in robot-assisted radical prostatectomy., Methods: We included 814 patients treated with robot-assisted radical prostatectomy between 2009 and 2021, and evaluated the impact of nerve sparing on positive surgical margin and biochemical recurrence using logistic regression and Cox models., Results: Unilateral nerve sparing and bilateral nerve sparing were performed in 152 (18.6%) cases and 118 (14.5%) cases, respectively. On multivariable analysis, in addition to nerve sparing, bilateral nerve sparing, but not unilateral nerve sparing was associated with an increased risk of positive surgical margin compared with non-nerve sparing. Positive surgical margin at any location increased the risk of biochemical recurrence. During unilateral nerve sparing, positive surgical margin in nerve sparing side, but not in non-nerve sparing side was associated with increased risk of biochemical recurrence on multivariate analysis., Conclusions: Taken together, surgeons need to notice an increased risk of biochemical recurrence associated with positive surgical margin when performing nerve sparing in robot-assisted radical prostatectomy, and then need to choose the patients suitable for nerve sparing., (© 2022 The Japanese Urological Association.)
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- 2022
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16. Validation of models predicting lymph node involvement probability in patients with prostate cancer.
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Blas L, Shiota M, Nagakawa S, Tsukahara S, Matsumoto T, Monji K, Kashiwagi E, Takeuchi A, Inokuchi J, and Eto M
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- Humans, Lymph Nodes pathology, Lymph Nodes surgery, Lymphatic Metastasis pathology, Male, Probability, Pelvis pathology, Prostatic Neoplasms pathology, Prostatic Neoplasms surgery
- Abstract
Objectives: There are many models to predict lymph node involvement in patients with prostate cancer. We aimed to externally validate several models in a Japanese cohort., Methods: We considered patients who were treated with robotic-assisted radical prostatectomy with extended pelvic lymph node dissection for prostate cancer. The risk of lymph node involvement was calculated for each patient in several models. Model performance was assessed by calculating the receiver operating characteristic curve and the area under the curve, calibration plots, and decision curve analyses., Results: We identified lymph node involvement in 61 (18.4%) of the 331 considered patients. Patients with lymph node involvement had a higher prostate-specific antigen level, percentage of positive biopsy cores, primary Gleason grade, Gleason group grade, and clinical T-stage category. The Memorial Sloan Kettering Cancer Center web calculator presented the highest area under the curve (0.78) followed by the Yale formula area under the curve (0.77), the updated version of Briganti nomogram of 2017 area under the curve (0.76), and the updated version of the Partin table by Tosoian et al. had an area under the curve of 0.75. However, the 95% confidence interval for these models overlapped. The calibration plot showed that the Memorial Sloan Kettering Cancer Center web calculator and the updated version of the Briganti nomogram calibrated better. In the decision curve analyses, all models showed net benefit; however, it overlapped among them. However, the Memorial Sloan Kettering Cancer Center web calculator and the updated Briganti nomogram presented the highest net benefit for lymph node involvement risks <35%., Conclusion: Models predicting lymph node involvement were externally validated in Japanese men. The Memorial Sloan Kettering Cancer Center web calculator and the updated Briganti nomogram of 2017 were the most accurate performing models., (© 2022 The Japanese Urological Association.)
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- 2022
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17. Editorial Comment to Effect of upfront combination therapy on the overall survival of patients with metastatic castration-sensitive prostate cancer: A multicenter retrospective study.
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Shiota M
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- Androgen Antagonists therapeutic use, Castration, Humans, Male, Retrospective Studies, Prostatic Neoplasms drug therapy, Prostatic Neoplasms surgery, Prostatic Neoplasms, Castration-Resistant drug therapy, Prostatic Neoplasms, Castration-Resistant pathology
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- 2022
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18. Efficacy of combined androgen blockade therapy in patients with metastatic hormone-sensitive prostate cancer stratified by tumor burden.
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Nagumo Y, Onozawa M, Kojima T, Terada N, Shiota M, Mitsuzuka K, Yasumoto H, Matsumoto H, Enokida H, Sugiyama T, Kuroiwa K, Saito T, Yokomizo A, Kohei N, Tabata KI, Takahashi A, Sugimoto M, Kitamura H, Kamoto T, and Nishiyama H
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- Androgens, Humans, Male, Retrospective Studies, Tumor Burden, Androgen Antagonists therapeutic use, Prostatic Neoplasms drug therapy
- Abstract
Objective: To determine the effect of combined androgen blockade with a first-generation anti-androgen on the prognoses of metastatic hormone-sensitive prostate cancer patients stratified by tumor burden., Methods: We retrospectively analyzed the cases of metastatic hormone-sensitive prostate cancer patients who were treated with androgen deprivation therapy in 2008-2017 at 30 institutions in Japan. To compare the overall survival and progression-free survival rates of the patients treated with castration monotherapy and combined androgen blockade, we carried out a Cox proportional hazards regression analysis using both inverse probability of treatment weighting and instrumental variables methods. High-burden disease was defined as the presence of four or more bone metastases and/or visceral metastasis., Results: Of 2048 patients, 702 (34.3%) and 1346 (65.7%) patients were classified as the low- and high-burden groups, respectively. In each group, >80% of the patients were treated with combined androgen blockade. Although there was no significant between-group difference in the overall survival according to the androgen deprivation therapy method, in the high-burden group the progression-free survival of the combined androgen blockade-treated patients was significantly better than that of patients treated with castration monotherapy: inverse probability of treatment weighting method, hazard ratio 0.49, 95% confidence interval 0.34-0.71; instrumental variables method, hazard ratio 0.80, 95% confidence interval 0.60-0.98., Conclusion: In the high-burden group, combined androgen blockade with a first-generation anti-androgen resulted in superior progression-free survival compared with castration monotherapy. For well-selected metastatic hormone-sensitive prostate cancer patients, the use of combined androgen blockade might still have some suitable scenarios., (© 2022 The Japanese Urological Association.)
- Published
- 2022
- Full Text
- View/download PDF
19. Predictive factors of survival outcomes in first-line therapy for metastatic castration-resistant prostate cancer.
- Author
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Shiota M, Blas L, Kobayashi S, Matsumoto T, Kashiwagi E, Takeuchi A, Inokuchi J, Shiga KI, Yokomizo A, and Eto M
- Subjects
- Androgen Antagonists therapeutic use, Androgen Receptor Antagonists, Disease-Free Survival, Docetaxel therapeutic use, Humans, Male, Nitriles, Progression-Free Survival, Prostate-Specific Antigen, Retrospective Studies, Treatment Outcome, Prostatic Neoplasms, Castration-Resistant drug therapy
- Abstract
Objectives: To investigate predictive factors of survival of metastatic castration-resistant prostate cancer patients undergoing first-line treatment with androgen receptor pathway inhibitors or docetaxel., Methods: Japanese patients with metastatic castration-resistant prostate cancer treated with androgen receptor pathway inhibitor or docetaxel between 2008 and 2018 were included. The differential impact of various clinicopathological factors on the outcome, including progression-free survival and overall survival, was compared between treatment with androgen receptor pathway inhibitor and docetaxel., Results: Of 254 patients with metastatic castration-resistant prostate cancer, 119 (46.9%) and 135 (53.2%) were treated with androgen receptor pathway inhibitor and docetaxel, respectively. The multivariate analysis showed that androgen receptor pathway inhibitor was an independent prognostic factor for better progression-free survival (hazard ratio 0.62, 95% confidence interval 0.42-0.92, P = 0.016) and overall survival (hazard ratio 0.61, 95% confidence interval 0.41-0.93, P = 0.021), compared with docetaxel. Pretreatment prostate-specific antigen levels and time to castration-resistant prostate cancer were differentially associated with progression-free survival and overall survival between androgen receptor pathway inhibitor or docetaxel. In patients who presented <6 months to castration-resistant prostate cancer, progression-free survival was shorter in those treated with androgen receptor pathway inhibitor (median 1.1 months, 95% confidence interval 0.2-2.8 months) compared with those who received docetaxel (median 5.0 months, 95% confidence interval 1.8-6.7 months; P = 0.014)., Conclusions: First-line therapy with androgen receptor pathway inhibitor is associated with a better prognosis when compared with docetaxel, even after adjustment for prognostic factors. However, a shorter time to castration-resistant prostate cancer is associated with better progression-free survival for patients receiving docetaxel, suggesting that docetaxel is the preferred option for patients with a shorter time to castration-resistant prostate cancer., (© 2021 The Japanese Urological Association.)
- Published
- 2022
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- View/download PDF
20. Editorial Comment from Dr Shiota to Stage and cancer-specific mortality differ within specific Asian ethnic groups for upper tract urothelial carcinoma: North American population-based study.
- Author
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Shiota M
- Subjects
- Ethnicity, Humans, North America epidemiology, Carcinoma, Transitional Cell, Ureteral Neoplasms, Urinary Bladder Neoplasms, Urologic Neoplasms
- Published
- 2021
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- View/download PDF
21. Dynamics of conditional survival and risk factors in androgen deprivation therapy for prostate cancer using a multi-institutional Japan-wide database.
- Author
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Chikamatsu S, Shiota M, Onozawa M, Hinotsu S, Kitagawa Y, Sakamoto S, Kawai T, Eto M, Kume H, and Akaza H
- Subjects
- Aged, Androgens, Humans, Japan epidemiology, Male, Risk Factors, Androgen Antagonists therapeutic use, Prostatic Neoplasms drug therapy
- Abstract
Objectives: The objectives of this study were to analyze the conditional survival and prognostic factors in androgen deprivation therapy for prostate cancer using the Japan Study Group of Prostate Cancer database., Methods: Data on patients treated with primary androgen deprivation therapy between 2001 and 2003 from a nationwide database of the Japan Study Group of Prostate Cancer were used. The conditional 5-year progression-free rate, cancer-specific survival and overall survival, as well as the conditional mortality owing to prostate cancer and other causes were calculated as per subgroups. Prognostic factors for progression-free rate, cancer-specific survival and overall survival at each time after androgen deprivation therapy initiation were calculated using the Cox proportional hazards model., Results: The conditional 5-year progression-free rate and cancer-specific survival, but not overall survival, gradually increased with time. The prognostic impact of stage IV characteristics (T4, N1 and M1) changed over time; however, the prognostic impact of the Gleason score remained unchanged. In the subgroup analysis, prostate-specific mortality risk reduced over time in patients with stage IV prostate cancer, whereas non-prostate cancer mortality increased over time in elderly patients., Conclusions: Information regarding conditional survival and mortality obtained in this study would provide a benchmark for physicians and cancer survivors., (© 2021 The Japanese Urological Association.)
- Published
- 2021
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- View/download PDF
22. Clinical advantages of robot-assisted partial nephrectomy versus laparoscopic partial nephrectomy in terms of global and split renal functions: A propensity score-matched comparative analysis.
- Author
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Kobayashi S, Mutaguchi J, Kashiwagi E, Takeuchi A, Shiota M, Inokuchi J, and Eto M
- Subjects
- Glomerular Filtration Rate, Humans, Nephrectomy adverse effects, Propensity Score, Retrospective Studies, Treatment Outcome, Kidney Neoplasms surgery, Laparoscopy, Robotic Surgical Procedures adverse effects, Robotics
- Abstract
Objectives: To identify predictors of renal function preservation, and to compare the global and split renal function outcomes of robot-assisted partial nephrectomy and laparoscopic partial nephrectomy., Methods: Demographic, operative and pathological data, as well as renal function outcomes, of 251 patients who underwent laparoscopic (n = 104) and robot-assisted (n = 147) partial nephrectomy between 2008 and 2018 were retrospectively analyzed. Propensity score matching (1:1) was carried out to adjust for potential baseline confounders. Functional outcomes were assessed based on the estimated glomerular filtration rate and dynamic renal scintigraphy (using
99m Tc-mercaptoacetyltriglycine), including renal volumetric analysis., Results: A total of 98 patients were allocated to each partial nephrectomy group. Ischemic (laparoscopic vs robot-assisted partial nephrectomy: 29 vs 15 min, P < 0.001) and operative times (181 vs 100 min, P < 0.001) were shorter in robot-assisted partial nephrectomy. The preservation ratio of global renal function at 3 months (88.3% vs 91.4%, P = 0.040) and 12 months (87.8% vs 91.5%, P = 0.010) postoperatively, and the renal function of the operated kidney (80.3% vs 88.2%, P < 0.001) were greater after robot-assisted partial nephrectomy. In robot-assisted partial nephrectomy, the volume of resected parenchyma was significantly smaller (27.2 vs 15.5 mL, P < 0.001), resulting in greater postoperative normal parenchymal volumes (120 vs 132 mL, P < 0.001) and a greater parenchymal preservation ratio (81.1% vs 90.1%, P < 0.001). The parenchymal preservation ratio was the strongest predictor of renal function preservation after surgery (P < 0.001, odds ratio 6.02)., Conclusions: Robot-assisted partial nephrectomy allows better preservation of split renal function than laparoscopic partial nephrectomy by increasing the parenchymal preservation ratio. This translates into better postoperative global renal function., (© 2021 The Japanese Urological Association.)- Published
- 2021
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23. Regional and facility disparities in androgen deprivation therapy for prostate cancer from a multi-institutional Japan-wide database.
- Author
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Shiota M, Sumikawa R, Onozawa M, Hinotsu S, Kitagawa Y, Sakamoto S, Kawai T, Eto M, Kume H, and Akaza H
- Subjects
- Androgens, Humans, Japan epidemiology, Male, Prognosis, Androgen Antagonists therapeutic use, Prostatic Neoplasms drug therapy
- Abstract
Objectives: To examine the differences in prognosis of prostate cancer patients receiving primary androgen deprivation therapy by region and facility type using a Japan-wide database., Methods: Data on patients treated with primary androgen deprivation therapy between 2001 and 2003 from a nationwide community-based database established by the Japan Study Group of Prostate Cancer were obtained. Clinicopathological characteristics and prognostic variables, including progression, cancer-specific survival and overall survival, were compared according to region and facility type where the patients were treated., Results: Among 19 162 patients, 7102 (37.1%) and 12 060 (62.9%) men were in urban and rural areas, respectively, and 3556 (18.6%), 13 623 (71.1%) and 1983 (10.3%) patients were enrolled from academic centers, non-academic hospitals and urological clinics, respectively. The risks of progression, cancer-specific mortality and all-cause mortality were comparable between urban and rural areas in propensity-score matched analysis. Risks of progression, cancer-specific mortality and all-cause mortality in urological clinics were higher than those in academic centers in propensity-score matched analysis., Conclusions: Our findings suggest that Japan facility type, but not geographical regions, might affect the prognosis of prostate cancer patients receiving primary androgen deprivation therapy., (© 2021 The Japanese Urological Association.)
- Published
- 2021
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24. Genomic characteristics revealed by targeted exon sequencing of testicular germ cell tumors in Japanese men.
- Author
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Matsumoto T, Shiota M, Uchiumi T, Ueda S, Tsukahara S, Toshima T, Matsumoto S, Noda N, Eto M, and Kang D
- Subjects
- Exons, Genomics, Humans, Japan, Male, Mutation, Phosphatidylinositol 3-Kinases, Proto-Oncogene Proteins c-kit genetics, Neoplasms, Germ Cell and Embryonal genetics, Testicular Neoplasms genetics
- Abstract
Objective: To investigate the somatic mutation profiles of testicular germ cell tumors in Japanese men., Methods: We analyzed the somatic missense mutation profile of testicular germ cell tumors among 21 Japanese men with seminoma (n = 14), pure embryonic carcinoma (n = 3) and mixed testicular germ cell tumor (n = 4) by targeted next-generation sequencing of 409 cancer-related genes covering 1.23 Mb of the genome., Results: We identified a total of 22 missense mutations in 21 primary testicular germ cell tumor samples (0.89 mutations/Mb), of which seven mutations were confirmed to be absent from the germline. KIT:p.Asn822Tyr, KIT:p.Leu576Pro, PIK3CA:p.Glu542Lys and FBXW7:p.Arg505His were statistically and functionally potential. A total of 18 missense mutations were previously unknown in testicular germ cell tumors. PDGFRA amplification from one patient with seminoma was detected. KIT, BCR,PIK3CG, PIK3CA and PDGFRA mutations involved in aberrant signaling of the KIT-PI3K-AKT pathway was detected in 27.3% of detected mutations., Conclusions: The present investigation identified a low mutation rate in testicular germ cell tumors among Asian patients, 18 novel mutations and PDGFRA amplification. Limitations of the present study are the small sample and missing normal DNA for some testicular germ cell tumors., (© 2020 The Japanese Urological Association.)
- Published
- 2021
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25. Impact of antiandrogen withdrawal syndrome in castration-resistant prostate cancer patients treated with abiraterone or enzalutamide.
- Author
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Shiota M, Machidori A, Abe T, Monji K, Kashiwagi E, Takeuchi A, Takahashi R, Inokuchi J, Yokomizo A, Naito S, and Eto M
- Subjects
- Androstenes adverse effects, Benzamides, Humans, Male, Nitriles, Phenylthiohydantoin analogs & derivatives, Prostate-Specific Antigen, Treatment Outcome, Androgen Antagonists adverse effects, Prostatic Neoplasms, Castration-Resistant drug therapy
- Abstract
Objectives: To assess the impact of antiandrogen withdrawal syndrome after bicalutamide withdrawal in castration-resistant prostate cancer patients treated with androgen receptor-axis targeted agents., Methods: The study cohort comprised 94 patients treated with abiraterone (n = 34) or enzalutamide (n = 60) as a first-line androgen receptor-axis targeted agent for castration-resistant prostate cancer despite combined androgen blockade by castration with bicalutamide as the first-line therapy. The association between clinicopathological factors (including antiandrogen withdrawal syndrome) and therapeutic outcome after using abiraterone and enzalutamide was investigated., Results: The decline in the prostate-specific antigen level after use of abiraterone or enzalutamide was comparable between patients with and without antiandrogen withdrawal syndrome. Antiandrogen withdrawal syndrome (hazard ratio 3.84, 95% confidence interval 1.29-11.45; P = 0.016) was associated with a higher risk of progression on multivariate analysis, but not all-cause death after abiraterone use. Progression-free survival and overall survival after enzalutamide use did not differ between patients with and without antiandrogen withdrawal syndrome., Conclusions: The present data suggest a modest therapeutic efficacy of abiraterone in castration-resistant prostate cancer patients with anti-androgen withdrawal syndrome after bicalutamide withdrawal., (© 2020 The Japanese Urological Association.)
- Published
- 2020
- Full Text
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26. Family history in primary hormone therapy for prostate cancer: Analysis from a community-based multi-institutional Japan-wide database.
- Author
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Shiota M, Onozawa M, Hinotsu S, Eto M, Naito S, and Akaza H
- Subjects
- Hormones, Humans, Japan epidemiology, Male, Medical History Taking, Prognosis, Prostate-Specific Antigen, Prostatic Neoplasms drug therapy, Prostatic Neoplasms genetics
- Abstract
Objectives: To determine the association between hormone therapy and outcomes in a cohort of prostate cancer patients with a family history of prostate cancer., Methods: Data of patients with prostate cancer who had received hormone therapy were extracted from a nationwide community-based database established by the Japan Study Group for Prostate Cancer. Family history of prostate cancer was available for 13 346 of these patients, who thus comprised the study cohort. Prognostic variables, including progression-free survival, cancer-specific survival and overall survival, were compared between men with familial and men with sporadic prostate cancer., Results: A positive family history was identified in 220 patients (1.6%). Patients with a positive family history were younger than those without; however, other clinicopathological characteristics and prognoses were comparable. In subgroup analysis, family history was identified as a possible favorable prognostic factor for overall survival among patients with a prostate-specific antigen level at diagnosis <100 ng/mL and those with low or intermediate Japan Cancer of the Prostate Risk Assessment., Conclusions: Our findings show that familial prostate cancer has an early-onset feature or is diagnosed earlier than sporadic prostate cancer. However, the prognosis of individuals with familial prostate cancer undergoing hormone therapy is comparable to those with sporadic prostate cancer., (© 2020 The Japanese Urological Association.)
- Published
- 2020
- Full Text
- View/download PDF
27. Editorial Comment from Dr Shiota to Magnetic resonance imaging/transrectal ultrasonography fusion targeted prostate biopsy finds more significant prostate cancer in biopsy-naïve Japanese men compared with the standard biopsy.
- Author
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Shiota M
- Subjects
- Humans, Image-Guided Biopsy, Japan, Magnetic Resonance Imaging, Male, Ultrasonography, Prostatic Neoplasms
- Published
- 2020
- Full Text
- View/download PDF
28. Editorial Comment to Validation and development of the CHAARTED criteria in patients with hormone-naïve metastatic prostate cancer: A multi-institutional retrospective study in Japan.
- Author
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Shiota M
- Subjects
- Androgen Antagonists, Humans, Japan, Male, Retrospective Studies, Prostatic Neoplasms
- Published
- 2020
- Full Text
- View/download PDF
29. Prognostic significance of risk stratification in CHAARTED and LATITUDE studies among Japanese men with de novo metastatic prostate cancer.
- Author
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Shiota M, Namitome R, Kobayashi T, Inokuchi J, Tatsugami K, and Eto M
- Subjects
- Aged, Androstenes administration & dosage, Biopsy, Large-Core Needle, Clinical Trials as Topic, Disease Progression, Docetaxel administration & dosage, Humans, Japan, Male, Neoplasm Recurrence, Local epidemiology, Neoplasm Recurrence, Local pathology, Neoplasm Recurrence, Local prevention & control, Orchiectomy, Prognosis, Progression-Free Survival, Prostate pathology, Prostatic Neoplasms diagnosis, Prostatic Neoplasms mortality, Prostatic Neoplasms pathology, Retrospective Studies, Risk Assessment methods, Androgen Antagonists administration & dosage, Antineoplastic Agents administration & dosage, Neoplasm Recurrence, Local diagnosis, Prostatic Neoplasms therapy
- Published
- 2019
- Full Text
- View/download PDF
30. Current status of primary pharmacotherapy and future perspectives toward upfront therapy for metastatic hormone-sensitive prostate cancer.
- Author
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Shiota M and Eto M
- Subjects
- Biomarkers, Tumor, Disease Progression, Humans, Male, Taxoids, Androgen Antagonists therapeutic use, Prostatic Neoplasms, Castration-Resistant drug therapy
- Abstract
Since 1941, androgen deprivation therapy has been the primary treatment for metastatic hormone-sensitive prostate cancer. Androgen deprivation therapy consists of several regimens that vary according to therapeutic modality, as well as treatment schedule. Androgen deprivation therapy initially shows excellent antitumor effects, such as relief of cancer-related symptoms, tumor marker decline and tumor shrinking. However, most metastatic hormone-sensitive prostate cancer cases eventually develop castration resistance and become lethal. Taxanes, such as docetaxel and cabazitaxel, as well as novel androgen receptor-targeting agents, such as abiraterone acetate and enzalutamide, have emerged for metastatic castration-resistant prostate cancer. The concept and principle of primary therapy for metastatic hormone-sensitive prostate cancer has remained unchanged for decades. Recently, upfront docetaxel chemotherapy has been shown to prolong overall survival in men with metastatic hormone-sensitive prostate cancer, and would lead to a paradigm shift in primary pharmacotherapy for metastatic hormone-sensitive prostate cancer. This raises the possibility of upfront use of taxanes, as well as novel androgen receptor-targeting agents combined with androgen deprivation therapy. The present review summarizes the current status of primary pharmacotherapy for metastatic hormone-sensitive prostate cancer, and discusses future perspectives in this field., (© 2016 The Japanese Urological Association.)
- Published
- 2016
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- View/download PDF
31. Editorial comment from Dr Shiota to Prognostic impact of young age on stage IV prostate cancer treated with primary androgen deprivation therapy.
- Author
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Shiota M
- Subjects
- Humans, Male, Androgen Antagonists therapeutic use, Prostatic Neoplasms drug therapy, Prostatic Neoplasms pathology
- Published
- 2014
- Full Text
- View/download PDF
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