Impact of the coronavirus disease pandemic on robot-assisted radical prostatectomy and urologists' treatment behaviors: A single tertiary center retrospective study.

OBJECTIVES: To assess whether the coronavirus disease (COVID-19) pandemic affected the outcomes of robot-assisted radical prostatectomy (RARP) and urologists' treatment behaviors. METHODS: We retrospectively examined the medical records of 208 patients who had undergone RARP between August 2017 and December 2022. We compared the rate of preoperative androgen deprivation therapy (ADT), waiting period for RARP, patients' baseline characteristics and quality of life (QOL), proportion of adverse pathology on the RARP specimen, rate of Gleason grade group upgrading from biopsy to the RARP specimen, and prostate-specific antigen (PSA) recurrence-free survival between the pre-pandemic and pandemic groups. RESULTS: The rate of preoperative ADT was significantly higher during than before the COVID-19 pandemic (13.7% vs. 1.9%; p = 0.002). The baseline physical and mental QOL scores did not differ significantly between the groups. The proportion of D'Amico low-risk patients was significantly lower (13.6% vs. 1.2%, p = 0.005) and waiting period for RARP was significantly shorter (median 3.5 months vs. 4.0 months, p = 0.016) in the pandemic group than in the pre-pandemic group. There was no significant difference in the proportion of adverse pathology between the groups (p = 0.104); however, the upgrading rate was significantly higher in the pre-pandemic group (p = 0.002). There was no significant difference in PSA recurrence-free survival between the groups (log-rank, p = 0.752). CONCLUSIONS: The COVID-19 pandemic did not adversely affect the oncologic outcomes of RARP and QOL before RARP. However, it caused urologists to increase the use of preoperative ADT and to reserve RARP for higher-risk cases.

Usefulness of fluorescent ureteral catheter during laparoscopic residual ureterectomy.

Introduction: There have been reports of surgery for residual ureteral tumors, most of them involved open surgeries. Herein, we report a case of retroperitoneal scopic left ureteral resection and partial cystectomy, performed by placing a fluorescent ureteral catheter in the residual ureter. Case presentation: A 79-year-old man was admitted to our hospital with a chief complaint of gross hematuria. He had undergone transperitoneal left radical nephrectomy due to angiomyolipoma 20 years ago. Computed tomography and Magnetic resonance imaging revealed a solid tumor in the left residual ureter. Retroperitoneal scopic residual ureterectomy has been performed. During the operation, a fluorescent ureteral catheter proved to be very helpful in detecting the ureter. Conclusion: A fluorescent ureteral catheter is considered to be a useful tool in laparoscopic surgery, especially in cases where identification of the ureter is expected to be difficult, such as the residual ureter in this case.

Impact of frailty on cancer-related fatigue and quality of life in outpatients with prostate cancer: a cross-sectional study of patient-reported outcomes.

OBJECTIVE: To investigate the prevalence of frailty and its effects on cancer-related fatigue and quality of life among patients with prostate cancer. METHODS: In this cross-sectional study, questionnaires were administered to 254 outpatients who visited the Department of Urology at Kagawa University Hospital for prostate cancer; finally, 108 outpatients were analyzed. Frailty, cancer-related fatigue and quality of life were assessed using the G8 screening tool, Japanese version of the Brief Fatigue Inventory and Japanese version of the Short Form 8 Health Survey, respectively. We defined frailty based on a score ≤14 points and divided the patients into frailty and no-frailty groups. We also compared the severity of cancer-related fatigue and quality of life between groups. RESULTS: The prevalence of frailty among 108 outpatients was 63%. Older age correlated with frailty severity (P = 0.0007) but not cancer-related fatigue severity (P = 0.2391). The proportion of patients on treatment or with metastasis was not significantly different between groups. The frailty group had higher cancer-related fatigue severity (P = 0.004) and decreased levels of general activity, mood, walking ability, normal work and enjoyment of life, especially on the Brief Fatigue Inventory subscale. The frailty group had lower physical and mental quality of life than the no-frailty group or general population. CONCLUSIONS: The frailty rate for these patients increased with age, exceeding 60% regardless of the treatment status, and was associated with worsened cancer-related fatigue severity and reduced quality of life. Our study highlights the importance of assessing frailty when selecting treatment, especially in older patients.

Peripheral neuropathy and nerve electrophysiological changes with enfortumab vedotin in patients with advanced urothelial carcinoma: a prospective multicenter cohort study.

BACKGROUND: Enfortumab vedotin is a novel antibody-drug conjugate used as a third-line therapy for the treatment of urothelial cancer. We aimed to elucidate the effect of enfortumab vedotin-related peripheral neuropathy on its efficacy and whether enfortumab vedotin-induced early electrophysiological changes could be associated with peripheral neuropathy onset. METHODS: Our prospective multicenter cohort study enrolled 34 patients with prior platinum-containing chemotherapy and programmed cell death protein 1/ligand 1 inhibitor-resistant advanced urothelial carcinoma and received enfortumab vedotin. The best overall response, progression-free survival, overall survival, and safety were assessed. Nerve conduction studies were also performed in 11 patients. RESULTS: The confirmed overall response rate and disease control rate were 52.9% and 73.5%, respectively. The median overall progression-free survival and overall survival were 6.9 and 13.5 months, respectively, during a median follow-up of 8.6 months. The patients with disease control had significantly longer treatment continuation and overall survival than did those with uncontrolled disease. Peripheral neuropathy occurred in 12.5% of the patients. The overall response and disease control rates were 83.3% and 100%, respectively: higher than those in patients without peripheral neuropathy (p = 0.028 and p = 0.029, respectively). Nerve conduction studies indicated that enfortumab vedotin reduced nerve conduction velocity more markedly in sensory nerves than in motor nerves and the lower limbs than in the upper limbs, with the sural nerve being the most affected in the patients who developed peripheral neuropathy (p = 0.011). CONCLUSION: Our results indicated the importance of focusing on enfortumab vedotin-induced neuropathy of the sural nerve to maximize efficacy and improve safety.

Real-world prostate-specific antigen response and progression to castration-resistant prostate cancer among men with metastatic castration-sensitive prostate cancer treated with apalutamide: a multi-institutional study in the Chu-shikoku Japan Urological Consortium.

BACKGROUND: Japanese men receiving apalutamide often experience skin-adverse events (AEs), possibly requiring treatment interruption or dose reduction. However, concerns have arisen regarding the impact of these adjustments on the efficacy of apalutamide. Our study evaluated the efficacy, safety, and persistence of apalutamide in men with metastatic castration-sensitive prostate cancer (mCSPC). METHODS: We retrospectively reviewed the medical records of 108 men with mCSPC from 14 Japanese institutions. The primary outcomes were the efficacy of apalutamide: prostate-specific antigen (PSA) response (50%, 90% and < 0.2 decline) and progression to castration-resistant prostate cancer (CRPC). The secondary outcomes were the skin-AE and compliance of apalutamide. RESULTS: PSA50%, PSA90% and PSA < 0.2 declines were observed in 89.8, 84.3 and 65.7%, and the median time to CRPC progression was not reached. PSA < 0.2 decline and an initial full dose of apalutamide were significantly associated with a longer time to CRPC. The most common AE was skin-AE (50.9%), and there was no association between the occurrence of skin-AE and the time to CRPC (P = 0.72). The median apalutamide persistence was 29 months, which was longer in the initial full dose recipients than in the reduced dose recipients. The dosage is reduced in about 60% of patients within the first year of treatment in the initial full dose recipients. CONCLUSIONS: Our findings indicate the effectiveness of apalutamide in Japanese men with mCSPC, despite a substantial portion requiring dose reduction within a year among the initial full dose recipients.

Aggressive Prostate Cancer in Patients Treated with Active Surveillance.

Active surveillance has emerged as a promising approach for managing low-risk and favorable intermediate-risk prostate cancer (PC), with the aim of minimizing overtreatment and maintaining the quality of life. However, concerns remain about identifying "aggressive prostate cancer" within the active surveillance cohort, which refers to cancers with a higher potential for progression. Previous studies are predictors of aggressive PC during active surveillance. To address this, a personalized risk-based follow-up approach that integrates clinical data, biomarkers, and genetic factors using risk calculators was proposed. This approach enables an efficient risk assessment and the early detection of disease progression, minimizes unnecessary interventions, and improves patient management and outcomes. As active surveillance indications expand, the importance of identifying aggressive PC through a personalized risk-based follow-up is expected to increase.

Development and internal validation of a screening tool for chronic prostatitis (S-CP).

PURPOSE: We developed a simple self-checkable screening tool for chronic prostatitis (S-CP) and internally validated it to encourage men (in the general population) with possible chronic prostatitis to consult urologists. METHODS: The expert panel proposed the S-CP, which comprises three domains: Area of pain or discomfort (6 components), accompanying Symptom (6 components), and Trigger for symptom flares (4 components). We employed logistic regression to predict chronic prostatitis prevalence with the S-CP. We evaluated the predictive performance using data from a representative national survey of Japanese men aged 20 to 84. We calculated the optimism-adjusted area under the curve using bootstrapping. We assessed sensitivity/specificity, likelihood ratio, and predictive value for each cutoff of the S-CP. RESULTS: Data were collected for 5,010 men-71 (1.4%) had a chronic prostatitis diagnosis. The apparent and adjusted area under the curve for the S-CP was 0.765 [95% confidence interval (CI) 0.702, 0.829] and 0.761 (0.696, 0.819), respectively. When the cutoff was two of the three domains being positive, sensitivity and specificity were 62.0% (95% CI 49.7, 73.2) and 85.4% (95% CI 84.4, 86.4), respectively. The positive/negative likelihood ratios were 4.2 (95% CI 3.5, 5.2) and 0.45 (95% CI 0.33, 0.60), respectively. The positive/negative predictive values were 5.7 (95% CI 4.2, 7.6) and 99.4 (95% CI 99.1, 99.6), respectively. CONCLUSION: The reasonable predictive performance of the S-CP indicated that patients (in the general population) with chronic prostatitis were screened as a first step. Further research would develop another tool for diagnostic support in actual clinical settings.

Oral 5-aminolevulinic acid administration before transurethral resection of bladder tumor induces perioperative nausea and vomiting.

BACKGROUND: The efficacy of photodynamic diagnosis using 5-aminolevulinic acid during transurethral resection of bladder tumors has been demonstrated, albeit with limited information regarding its side effects. This study aimed to clarify the impact of oral 5-aminolevulinic acid on perioperative nausea and vomiting (NV) for the first time in a real-world clinical practice setting. METHODS: Patients who underwent transurethral surgery at Kagawa University between April 2017 and March 2020 were included. Perioperative NV and antiemetic use status were prospectively assessed and compared between the patients who received oral 5-aminolevulinic acid and those who did not. Additionally, univariate and multivariate analyses were performed for predicting postoperative nausea and vomiting. RESULTS: Of 214 patients, 74 (34.6%) received oral 5-aminolevulinic acid preoperatively. The proportions of preoperative NV and antiemetic use in the patients who received 5-aminolevulinic acid were 9.5% and 4.1%, respectively, and higher than in those who did not (0% and 0%; P < 0.01 and P = 0.04, respectively). Postoperative NV (25.7%) and antiemetics use (8.0%) ratios in the patients who received 5-aminolevulinic acid were significantly different from those in the non-users group (3.6% and 2.1%, P < 0.01 and P < 0.01, respectively). Although no differences in risk factors were found for postoperative NV between the two groups, multivariate analyses indicated 5-aminolevulinic acid use as an independent predictive factor for postoperative NV (odds ratio, 11.5; 95% confidence interval, 3.98-33.3; P < 0.01). CONCLUSIONS: Our study clearly showed that oral administration of 5-aminolevulinic acid was associated with perioperative NV even without risk factors, highlighting the need for addressing its application.

Increasing age predicts adverse pathology including intraductal carcinoma of the prostate and cribriform patterns in deferred radical prostatectomy after upfront active surveillance for Gleason grade group 1 prostate cancer: analysis of prospective observational study cohort.

BACKGROUND: In men undergoing upfront active surveillance, predictors of adverse pathology in radical prostatectomy specimens, including intraductal carcinoma of the prostate and cribriform patterns, remain unknown. Therefore, we aimed to examine whether adverse pathology in radical prostatectomy specimens could be predicted using preoperative patient characteristics. METHODS: We re-reviewed available radical prostatectomy specimens from 1035 men prospectively enrolled in the PRIAS-JAPAN cohort between January 2010 and September 2020. We defined adverse pathology on radical prostatectomy specimens as Gleason grade group ≥3, pT stage ≥3, pN positivity or the presence of intraductal carcinoma of the prostate or cribriform patterns. We also examined the predictive factors associated with adverse pathology. RESULTS: All men analyzed had Gleason grade group 1 specimens at active surveillance enrolment. The incidence of adverse pathologies was 48.9% (with intraductal carcinoma of the prostate or cribriform patterns, 33.6%; without them, 15.3%). The addition of intraductal carcinoma of the prostate or cribriform patterns to the definition of adverse pathology increased the incidence by 10.9%. Patients showing adverse pathology with intraductal carcinoma of the prostate or cribriform patterns had lower biochemical recurrence-free survival (log-rank P = 0.0166). Increasing age at active surveillance enrolment and before radical prostatectomy was the only predictive factor for adverse pathology (odds ratio: 1.1, 95% confidence interval: 1.02-1.19, P = 0.0178; odds ratio: 1.12, 95% confidence interval: 1.02-1.22, P = 0.0126). CONCLUSIONS: Increasing age could be a predictive factor for adverse pathology. Our findings suggest that older men could potentially derive advantages from adhering to the examination schedule in active surveillance.

A national questionnaire survey of Japanese urologists on treatment perspectives for elderly prostate cancer patients.

OBJECTIVE: This study conducted a national questionnaire survey of Japanese urologists from a treatment perspective for older patients with prostate cancer. METHODS: A questionnaire was distributed to 922 teaching hospitals of the Japanese Urological Association. Questionnaire items included years of urologist experience, gender, workplace, treatment equipment owned, daily specialty practice area, urological cancer specialty, treatment reference items for older adults, upper age limit for radical treatment, medication, and two hypothetical cases of Gleason grade group 2 prostate cancer with or without oligometastasis. RESULTS: In total, 1732 questionnaires were analyzed, with responses evenly distributed across all age groups. Workplaces included general hospitals (49.4%), university hospitals (40.3%), and cancer centers (4.2%). Performance status was the most frequently mentioned treatment-related item, followed by comorbidities and cognitive function. In addition, geriatric assessment was used by only 13.3% of respondents. No upper age limit was found for total prostatectomy, brachytherapy, and external beam radiation. Anti-androgens, androgen receptor-axis-targeted agents, chemotherapy, poly ADP ribose polymerase inhibitors, and immune-checkpoint inhibitors were selected by 6.8%, 35.6%, 47.3%, 89%, 62.8%, 24.7%, 41.9%, and 41.7% of the respondents, respectively. Response rates for administration of hormone therapy for hypothetical cases of Gleason grade group 2 prostate cancer with or without oligometastases were 96.8% and 61.2%, respectively. CONCLUSIONS: Less than 15% of urologists used geriatric assessments. Several responded that they would set age limits for highly invasive radical and systemic therapies.

A national questionnaire survey of Japanese urologists on active surveillance for low- and intermediate-risk prostate cancer.

OBJECTIVE: To conduct a national questionnaire survey of Japanese urologists on active surveillance (AS) for low- and intermediate-risk prostate cancer (PCa). METHODS: A questionnaire was sent to 922 Japanese Urological Association Teaching Base Hospitals. The items included were years of experience as a urologist, sex, workplace, treatment equipment owned, specialty area of daily practice, specialty area of urological cancer, and six hypothetical cases of AS. The cases were categorized by the following Gleason scores: 3 + 3 low risk of PCa, 3 + 4 intermediate risk, and 4 + 3 intermediate risk, with or without comorbidities for each case. Comorbidities were defined as cardiovascular diseases or illnesses warranting anticoagulant therapy. RESULTS: Altogether, 1962 questionnaires were analyzed. Responses were almost equally distributed among all age groups. Workplaces included general hospitals (49.4%), university hospitals (40.3%), and cancer centers (4.2%). Percentages of proposed AS for low risk/no comorbidity, low risk/with comorbidity, intermediate-risk 3 + 4/no comorbidity, intermediate risk 3 + 4/with comorbidity, intermediate risk 4 + 3/no comorbidity, and intermediate risk 4 + 3/with comorbidity were 90.5%, 90%, 39.5%, 48.7%, 15%, and 22%, respectively. Analysis of the correspondents' backgrounds showed that the more the urologists' years of experience, the less they were to advise AS of low-risk patients. In the presence of comorbidities, urologists across all age groups tended to propose AS, even in the same Gleason grade group. Cancer center urologists recommended AS more often than their counterparts at general and university hospitals. CONCLUSIONS: Approximately 40% of urologists proposed AS for intermediate-risk cases, confirming that AS for intermediate-risk patients is being considered in Japan.

Clinical outcomes of intraductal carcinoma or cribriform in radical prostatectomy specimens of men opting for active surveillance: data from the PRIAS-JAPAN study.

BACKGROUND: Among early stage prostate cancer patients, intraductal carcinoma of the prostate (IDC-P) and invasive cribriform are key prognostic factors; however, their presence and clinical significance following active surveillance (AS) are unknown. In men who opted for AS, we aimed to examine the presence and impact of IDC-P or cribriform, utilizing radical prostatectomy (RP) specimens. METHODS: We re-reviewed 137 RP specimens available in the PRIAS-JAPAN prospective cohort between January 2010 and September 2020. We assessed the presence of IDC-P or cribriform, and compared the patients' characteristics and prostate-specific antigen (PSA) recurrence-free survival after RP between groups with and without IDC-P or cribriform. In addition, we examined the predictive factors associated with IDC-P or cribriform. RESULTS: The percentage of patients with IDC-P or cribriform presence was 34.3% (47 patients). IDC-P or cribriform pattern was more abundant in the higher Gleason grade group in RP specimens (P < 0.001). The rates of PSA recurrence-free survival were significantly lower in the IDC-P or cribriform groups than in those without them (log rank P = 0.0211). There was no association between IDC-P or cribriform on RP with the Prostate Imaging-Reporting and Data System (PI-RADS) 4,5 score on magnetic resonance imaging (MRI) before RP even with adjustments for other covariates (OR, 1.43; 95% confidence interval [CI] 0.511-3.980, P = 0.497). CONCLUSIONS: IDC-P or cribriform comprised approximately one-third of all RP specimens in men who underwent RP following AS, confirming their prognostic significance.

The efficacy of sequential therapy with docetaxel and cabazitaxel for castration-resistant prostate cancer: A retrospective multi-institutional study in Japan.

OBJECTIVE: This study investigated the efficacy of docetaxel (DOC) and cabazitaxel (CBZ) and examined the factors associated with the prognosis of patients with castration-resistant prostate cancer (CRPC) receiving DOC-CBZ sequential treatment in Japanese real-world data. METHODS: We retrospectively evaluated data for 146 patients who received DOC followed by CBZ. The correlations of prostate specific antigen (PSA) decrease rate and time to progression between DOC and CBZ treatment were examined. Combined progression-free survival (PFS) of DOC-CBZ and overall survival (OS) from the initiation of DOC and the diagnosis of CRPC were evaluated and compared between patients with high and low PSA levels at the start of DOC and CBZ treatment. RESULTS: No correlations of PSA decrease rate and time to progression were observed between DOC and CBZ. The patients for whom DOC was started in higher PSA levels had significantly shorter combined PFS (p = 0.003) and OS from the initiation of DOC (p = 0.002). In patients who started DOC at high PSA levels, those who switched to CBZ at low PSA levels had longer OS than those who switched at high PSA levels (p = 0.048). The OS from CRPC of patients who started DOC at low PSA levels was significantly longer than those that started at high PSA levels (p = 0.030). CONCLUSIONS: For patients for whom DOC was not effective, sequential CBZ might have change to be effective. The PSA levels at the start of DOC and CBZ might be a potential prognostic biomarker.

Effect of continued perioperative antithrombotic therapy on bleeding outcomes following laparoscopic nephrectomy and nephroureterectomy.

INTRODUCTION: In this study, we aimed to assess the impact of perioperative continuation of antithrombotic therapy on bleeding and complications in patients undergoing laparoscopic radical nephrectomy (LRN) and nephroureterectomy (LNU). METHODS: This was a retrospective observational study. Patients who underwent LRN and LNU between January 2017 and July 2019 at our institution were recruited. All patients taking antithrombotic agents continued taking them during the perioperative phase (AA group). Surgical outcomes of patients in the AA group were compared with those of patients who were not taking antithrombotic agents (NA group). The primary outcome was the rate of bleeding complications. Secondary outcomes included intraoperative estimated blood loss, transfusion rate, and complications for up to 90 days. RESULTS: A total of 100 patients were included in the analysis, with 36 and 64 patients assigned to the AA and NA groups, respectively. Patients in the AA group were found to have more severe comorbidities than those in the NA group, with a Charlson Comorbidity Index ≥5, totaling 14 (39%) and 12 (19%), respectively (P = .03). According to surgical outcomes, none of the patients in the AA group required secondary procedures for bleeding complications. Moreover, there were no significant differences between the groups in intraoperative blood loss, hemoglobin deficit, rate of perioperative transfusion, readmission rate, or high-grade complications. DISCUSSION: These results indicate that perioperative use of antithrombotic agents does not increase the risk of bleeding and can be considered safe during LRN and LNU.

Active surveillance in younger patients with prostate cancer: clinical characteristics including longitudinal patient-reported outcomes.

OBJECTIVE: this study aimed to evaluate the active surveillance continuation period, treatment intervention rate and health-related quality of life in younger patients. METHODS: we prospectively conducted a health-related quality of life survey of patients enrolled in the Prostate Cancer Research International: Active Surveillance-JAPAN study at Kagawa University between January 2010 and December 2020. Health-related quality of life was assessed by mail using a validated Japanese version of the Short-Form 8 Health Survey and Expanded Prostate Cancer Index at active surveillance enrolment and annually thereafter until discontinuation of active surveillance. We divided the patients into two groups, younger (aged <65 years) and older (aged ≥65 years), and compared the two groups. RESULTS: of the 84 patients, 22 were in the younger group. The active surveillance continuation period was shorter in the younger group than in the older group. The 3-year treatment intervention rate was higher in the younger group than in the older group. The majority of the reasons for definitive treatment were related to the protocol, which was similar in both groups (80 versus 76%). The sexual summary scores at active surveillance enrolment were higher in the younger group than in the older group. During active surveillance, the younger group and the older group showed no deterioration in all health-related quality of life scores compared with the scores at the enrolment of active surveillance. CONCLUSIONS: patient-reported health-related quality of life survey indicated that the health-related quality of life of younger Japanese patients was maintained over time during active surveillance, similar to that of older patients.

Quantitative [99mTc]Tc-MDP SPECT/CT correlated with [18F]NaF PET/CT for bone metastases in patients with prostate cancer.

BACKGROUND: The purpose of the present study was to elucidate the correlation between standardized uptake value (SUV) and volume-based parameters measured by quantitative [99mTc]Tc-methylene diphosphonate (MDP) single photon emission computed tomography (SPECT)/CT and [18F]-sodium fluoride ([18F]NaF) positron emission tomography (PET)/CT in the assessment of bone metastases in patients with prostate cancer. METHODS: The study included 26 male prostate cancer patients with confirmed or suspected bone metastases who underwent both [99mTc]Tc-MDP SPECT/CT and [18F]NaF PET/CT studies. Skeletal lesions visible on both SPECT/CT and PET/CT were classified as benign or metastases. The maximum SUV (SUVmax), peak SUV (SUVpeak), mean SUV (SUVmean), metabolic bone volume (MBV), and total bone uptake (TBU) were calculated for every lesion showing abnormal uptake. RESULTS: A total of 202 skeletal lesions (147 benign and 55 metastases) were detected in the 26 patients. Strong significant correlations were noted between SPECT/CT and PET/CT for the SUV- and volume-based parameters (all P < 0.001). The SUVmax, SUVpeak, SUVmean, and TBU values obtained with SPECT/CT were significantly lower than the corresponding values obtained with PET/CT (all P < 0.001). The MBV in SPECT/CT was significantly higher than that in PET/CT (P < 0.001). All SUV- and volume-based parameters obtained with both SPECT/CT and PET/CT for metastatic lesions were significantly higher than the corresponding parameters for benign lesions (P values from 0.036 to < 0.001). CONCLUSIONS: These preliminary results demonstrate that the SUV- and volume-based parameters for bone uptake obtained with quantitative SPECT/CT and PET/CT are strongly correlated in patients with prostate cancer. The SUV parameters obtained with SPECT/CT were significantly lower than those obtained with PET/CT, whereas the uptake volume obtained with SPECT/CT was significantly higher than that obtained with PET/CT.

Acute generalized exanthematous pustulosis during apalutamide treatment in a patient with prostate cancer.

Introduction: Acute generalized exanthematous pustulosis is a type of severe cutaneous drug adverse reaction. While apalutamide is known for its high incidence of cutaneous adverse events, it remains unknown whether acute generalized exanthematous pustulosis can develop during apalutamide treatment. Case presentation: A 72-year-old man with metastatic castration-sensitive prostate cancer developed small erythema on the face and trunk after 41 days of apalutamide treatment. Three days later, apalutamide was discontinued. However, 9 days after the discontinuation of apalutamide, the patient had a high fever with hemodynamic instability and showed diffuse erythema throughout the body with numerous small pustules. Skin biopsy revealed subcorneal and intraepidermal pustules admixed with many eosinophils, which led to the diagnosis of acute generalized exanthematous pustulosis. The skin rash improved in 14 days with systemic corticosteroid administration. Conclusion: We present the first case of a skin rash with clinical features of acute generalized exanthematous pustulosis during apalutamide treatment.

Enzalutamide in patients with non-metastatic castration-resistant prostate cancer after combined androgen blockade for recurrence following radical treatment in Japan (Japanese research for patients with non-metastatic castration-resistant prostate cancer-enzalutamide: JCASTRE-zero)-a prospective single-arm interventional study.

BACKGROUND: The effect of enzalutamide in patients with non-metastatic castration-resistant prostate cancer after combined androgen blockade, which represents a patient profile similar to real-world clinical practice in Japan, remains unknown. Therefore, we investigate the efficacy and safety of enzalutamide after combined androgen blockade for recurrence following radical treatment in Japanese patients with non-metastatic castration-resistant prostate cancer. METHODS: We analyzed 66 patients with non-metastatic castration-resistant prostate cancer after combined androgen blockade for recurrence following radical prostatectomy or radiation therapy who were prospectively enrolled from October 2015 to March 2018. They received enzalutamide 160 mg orally once daily until the protocol treatment discontinuation criteria were met. The primary endpoint was prostate-specific antigen-progression-free survival, defined as the time from enrollment to prostate-specific antigen-based progression or death from any cause. The secondary endpoints included overall survival, progression-free survival, metastasis-free survival, time to prostate-specific antigen progression, prostate-specific antigen response rate, chemotherapy-free survival, and safety assessment. RESULTS: The median observation period was 27.3 months. The median prostate-specific antigen-progression-free survival was 35.0 months (95% confidence interval, 17.5 to not reached). The median overall survival, median progression-free survival, median metastasis-free survival, and chemotherapy-free survival were not reached, with the corresponding 2-year rates being 91.6%, 67.1%, 72.4%, and 85.8%, respectively. The 50% prostate-specific antigen response rate was 88.9%, with the median time being 2.8 months. In total, 42.2% of the patients experienced adverse events, with malaise being the most common. CONCLUSIONS: Enzalutamide effectively manages non-metastatic castration-resistant prostate cancer after combined androgen blockade for recurrence following radical treatment. TRIAL REGISTRATION:  UMIN000018964, CRB6180007.

Comparison of the medical costs between active surveillance and other treatments for early prostate cancer in Japan using data from the PRIAS-JAPAN study.

OBJECTIVES: To compare the medical costs of active surveillance with those of robot-assisted laparoscopic prostatectomy, brachytherapy, intensity-modulated radiation therapy, and hormone therapy for low-risk prostate cancer. METHODS: The costs of protocol biopsies performed in the first year of surveillance (between January 2010 and June 2020) and those of brachytherapy and radiation therapy performed between May 2019 and June 2020 at the Kagawa University Hospital were analyzed. Hormone therapy costs were assumed to be the costs of luteinizing hormone-releasing hormone analogs for over 5 years. Active surveillance-eligible patients were defined based on the following: age <74 years, ≤T2, Gleason score ≤6, prostate-specific antigen level ≤10 ng/ml, and 1-2 positive cores. We estimated the total number of active surveillance-eligible patients in Japan based on the Japan Study Group of Prostate Cancer (J-CAP) study and the 2017 cancer statistical data. We then calculated the 5-year treatment costs of active surveillance-eligible patients using the J-CAP and PRIAS-JAPAN study data. RESULTS: In 2017, number of active surveillance-eligible patients in Japan was estimated to be 2808. The 5-year total costs of surveillance, prostatectomy, brachytherapy, radiation therapy, and hormone therapy were 1.65, 14.0, 4.61, 4.04, and 5.87 million United States dollar (USD), respectively. If 50% and 100% of the patients in each treatment group had opted for active surveillance as the initial treatment, the total treatment cost would have been reduced by USD 6.89 million (JPY 889 million) and USD 13.8 million (JPY 1.78 billion), respectively. CONCLUSION: Expanding active surveillance to eligible patients with prostate cancer helps save medical costs.

Surgical and functional outcomes of robot-assisted versus laparoscopic partial nephrectomy with cortical renorrhaphy omission.

To evaluate the surgical and functional outcomes between robot-assisted (CRO-RAPN) vs. laparoscopic (CRO-LPN) methods of cortical-renorrhaphy-omitting partial nephrectomy. Between July 2012 and June 2020, patients with localized clinical T1-2 renal masses who underwent CRO-RAPN or CRO-LPN were reviewed. The outcomes of the two groups were compared using propensity-score matching. Trifecta was defined as negative surgical margin, warm ischemic time < 25 min, and absence of complications of Clavien-Dindo grade III or more until three months postoperatively. The preservation rate of the estimated glomerular filtration rate (eGFR) was evaluated at six months postoperatively. Among 291 patients (CRO-RAPN, n = 210; CRO-LPN, n = 81) included in the study, 150 matched pairs of patients were analyzed. Compared to the CRO-LPN group, the CRO-RAPN group was associated with shorter warm ischemic time (13 min vs. 20 min, P < 0.001), shorter total operation time (162 min vs. 212 min, P < 0.001), less estimated blood loss (40 mL vs. 119 mL, P = 0.002), lower incidence of overall complications (3% vs. 16%, P = 0.001), higher preservation rate of eGFR at six months postoperatively (93% vs. 89%, P = 0.003), and higher trifecta achievement rate (84% vs. 64%, P = 0.004). CRO-RAPN contributed to shorter warm ischemic time, less blood loss, fewer complications, and higher preservation of renal function, all of which allowed this technique to achieve a higher rate of trifecta compared to CRO-LPN.