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Objective: To report the outcomes of repeat biopsies, metastasis and survival in the Prostate Cancer Research International: Active Surveillance (PRIAS)‐JAPAN study, a prospective observational study for Japanese patients, initiated in 2010. Patients and Methods: At the beginning, inclusion criteria were initially low‐risk patients, prostate‐specific antigen (PSA) density (PSAD) <0.2, and ≤2 positive biopsy cores. As from 2014, GS3+4 has also been allowed for patients aged 70 years and over. Since January 2021, the age limit for Gleason score (GS) 3 + 4 cases was removed, and eligibility criteria were expanded to PSA ≤20 ng/mL, PSAD <0.25 nd/mL/cc, unlimited number of positive GS 3 + 3 cores, and positive results for fewer than half of the total number of cores for GS 3 + 4 cases if magnetic resonance imaging fusion biopsy was performed at study enrolment or subsequent follow‐up. For patients eligible for active surveillance, PSA tests were performed every 3 months, rectal examination every 6 months, and biopsies at 1, 4, 7 and 10 years, followed by every 5 years thereafter. Patients with confirmed pathological reclassification were recommended for secondary treatments. Results: As of February 2024, 1302 patients were enrolled in AS; 1274 (98%) met the eligibility criteria. The median (interquartile range) age, PSA level, PSAD, and number of positive cores were 69 (64–73) years, 5.3 (4.5–6.6) ng/mL, 0.15 (0.12–0.17) ng/mL, and 1 (1–2), respectively. The clinical stage was T1c in 1089 patients (86%) and T2 in 185 (15%). The rates of acceptance by patients for the first, second, third and fourth re‐biopsies were 83%, 64%, 41% and 22%, respectively. The pathological reclassification rates for the first, second, third and fourth re‐biopsies were 29%, 30%, 35% and 25%, respectively. The 1‐, 5‐ and 10‐year persistence rates were 77%, 45% and 23%, respectively. Six patients developed metastasis, and one patient died from prostate cancer. Conclusion: Pathological reclassification was observed in approximately 30% of the patients during biopsy; however, biopsy acceptance rates decreased over time. Although metastasis occurred in six patients, only one death from prostate cancer was recorded. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

This article discusses the prevalence of active surveillance (AS) for early-stage prostate cancer in Japan. A survey was conducted among cancer treatment facilities to assess the status of AS implementation. The results showed that the proportion of patients receiving AS was 10%, which is similar to the findings of a previous national survey in 2010. However, compared to Western countries, the use of AS in Japan is limited, indicating potential overdiagnosis and overtreatment of early-stage prostate cancer. The study suggests that patient education and physician support are needed to promote AS in Japan. [Extracted from the article]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Introduction: We examined the prevalence, pathological findings, and oncological outcomes of incidental bladder cancer found on cystoscopy among patients eligible for prostate biopsy (PB). Methods: We retrospectively reviewed 803 patients who underwent cystoscopy prior to PB between January 2010 and September 2020. In cases of bladder tumor-like findings on cystoscopy, biopsy or transurethral resection of the bladder tumor was performed. The primary and secondary outcomes were the prevalence of incidental bladder cancer and pathological and oncological outcomes of incidental bladder cancer, respectively. Results: Incidental findings were observed in 31/803 patients (3.9%). Bladder tumor-like findings were found in 24/803 patients (3%), while 9/803 patients (1.1%) were pathologically diagnosed with urothelial carcinoma. The stage and grade of incidental bladder cancer were pTa in 8/9 patients and pT1 in 1/9 and low grade in 8/9 and high in 1/9, respectively. The median tumor size of the papillary pedunculated type was 0.5 cm. At 26-month median follow-up, no recurrence was observed. Conclusion: Cystoscopy during PB may yield incidental bladder cancer findings, although the prevalence is very low. Incidental bladder cancer was of low stage and grade, which seemed unrelated to survival. Moreover, performing routine cystoscopy in conjunction with PB is not recommended as it may lead to overdiagnosis of low-risk bladder cancer. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the association between urine culture before transperineal prostate biopsy and post-biopsy febrile urinary tract infection (fUTI). Patients and Methods: We retrospectively reviewed 307 patients who underwent urine culture before transperineal prostate biopsy between April 2017 and September 2020. Patients with indwelling urinary catheters (n=7) were excluded. Urine culture was performed 1– 3 days before the biopsy, and all patients received prophylactic cefazolin regardless of culture results. A urine culture was defined as positive if cell density was more than 1× 105 colony-forming units per mL. Baseline characteristics and the incidence of post-biopsy fUTI were compared between patients showing positive pre-biopsy culture results and those showing negative findings. Results: Out of 300, seven patients (2.3%) had positive urine culture results before the biopsy. Age (p=0.077); prostate-specific antigen at diagnosis (p=0.267); prostate volume (p=0.78); number of biopsy cores (p=0.277); percentage of patients testing positive for cancer on biopsy (p=0.71); and percentages of patients with a history of biopsy (p> 0.999), diabetes mellitus (p=0.604), and immunosuppressive medication use (p> 0.999) were similar between the two groups. No patient in the positive urine culture group had post-biopsy fUTI. However, 1.7% (five patients) of the negative urine culture group had the disease (p> 0.999) (four patients with prostatitis and one with pyelonephritis). Among them, two patients were diagnosed by urine culture at the time of post-biopsy fUTI. Conclusion: In asymptomatic patients, positive pre-biopsy cultures were not associated with the development of post-biopsy fUTI. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to evaluate how health-related quality of life (HRQOL) is related to repeat protocol biopsy compliance.Materials and Methods: We conducted a retrospective analysis using data from a prospective cohort in the Prostate Cancer Research International: Active Surveillance (PRIAS)-JAPAN study between January 2010 and August 2019. We used the Short Form 8 Health Survey (SF-8), as patient-reported outcomes, to assess HRQOL at AS enrollment and the first year of the protocol. The physical component summary (PCS) and mental component summary (MCS) were calculated from SF-8 questionnaires. The primary outcome was the evaluation of the association of HRQOL at enrollment on the first repeat biopsy compliance. The secondary outcome was the comparison of SF-8 scores during AS, stratified by repeat protocol biopsy compliance.Results: Of 805 patients who proceeded to the first year of the protocol, the non-compliance rate was 15% (121 patients). In the adjusted model, lower MCS at enrollment was significantly associated with the first repeat protocol biopsy non-compliance (odds ratio [OR], 2.134; 95% confidence interval [CI], 1.031-4.42; P = 0.041) but not in lower PCS (OR, 0.667; 95% CI, 0.294-1.514; P = 0.333). All subscales of SF-8 were lower in the non-compliance group than in the compliance group at any point. MCS in the non-compliance group improved over time from the time of AS enrollment (2.34 increased, P = 0.152).Conclusion: Our data suggest that lower MCS at AS enrollment using patient-reported outcomes was negatively associated with the first repeat protocol biopsy compliance. Our study may support the availability of a simple questionnaire to extract non-compliance. [ABSTRACT FROM AUTHOR]

The proportion of Gleason pattern (GP) 4 prostate cancers at prostate biopsy has a clinically significant impact on risk stratification for patients with prostate cancer. In pathological diagnosis including GP 4, a biopsy Gleason score (GS) of 3+4 has a more favorable prognosis than a GS of 4+3 and 4+4. However, the discrepancy between biopsy and prostatectomy specimens is well known. The current study investigated the clinical parameters and biopsy specimens associated with pathological downgrading after prostatectomy in biopsies with a GS of 4+3 or 4+4 prostate cancer. A total of 302 patients with prostate cancer who underwent robot-assisted radical prostatectomy between August 2013 and May 2019 were retrospectively reviewed. A total of 103 patients had biopsies with GSs of 4+3 and GS 4+4 (unfavorable pathology). The proportion of patients who were downgraded from unfavorable disease to GS ≤3+4 (favorable pathology) in prostatectomy specimens was investigated. Logistic regression analysis was used to explore the association between clinical parameters and downgrading in prostatectomy specimens. A total of 43 patients (41.7%) were downgraded from biopsy GS to prostatectomy GS. The proportions of downgrade in biopsy GS 4+4 and 4+3 were 14.6 and 27.1%, respectively. The percentage of highest GS out of positive biopsy cores and the maximum percentage of cancer involvement within a positive core with the highest GS were lower in the downgrade group than in the no downgrade group (45 vs. 66.7%, P=0.025; 20 vs. 30%, P=0.048, respectively). When performing multivariate logistic regression analysis, the only significant predictor for downgrade was lower percentage of highest GS cores out of positive biopsy cores (odds ratio, 2.469; 95% confidence interval, 1.029-5.925 P=0.043). In conclusion, patients with biopsy GS 4+4 and 4+3 often exhibit a downgrade to GS 3+4 or less in prostatectomy specimens. The lower percentage of highest GS cores out of positive biopsy cores was associated with downgrade. [ABSTRACT FROM AUTHOR]