International Journal of Urology最新文献

Background: The effectiveness of docetaxel in addition to next-generation androgen receptor-axis-targeted therapies and androgen deprivation therapy (ADT) for metastatic hormone-sensitive prostate cancer (mHSPC) remains unclear. We evaluated the efficacy of this combination through tumor volume-specific analysis.

Methods: Individual patient data were reconstructed from seven clinical trials focusing mHSPC (ARASENS, PEACE-1, TITAN, ENZAMET, ARCHES, STAMPEDE, and LATITUDE) through the Shiny method. Overall survival (OS), radiological progression-free survival (rPFS), and time to castration-resistant prostate cancer (CRPC) were analyzed in the overall cohort and tumor volume-specific (high/low) subgroups. Sensitivity analyses were performed based on treatment methods and metastasis onset.

Results: In 6931 cases, adding docetaxel to ARAT and ADT did not significantly improve OS (hazard ratio [HR] = 1.07, 95% confidence interval [CI]: 0.95-1.22, p = 0.27), rPFS (HR = 0.88, 95% CI: 0.73-1.05, p = 0.16), or time to CRPC (HR = 0.97, 95% CI: 0.80-1.18, p = 0.74). High-volume disease showed a non-significant trend toward improved OS with the triplet regimen. Low-volume disease showed a similar trend. Sensitivity analyses for second-generation androgen receptor inhibitors indicated potentially less advantageous OS with docetaxel addition, but no significant differences when stratified by tumor volume. Analyses of the docetaxel-naïve, abiraterone, and synchronous metastasis subgroups showed no statistically significant differences in OS compared with the overall population and volume-stratified cases.

Conclusions: Patients with mHSPC did not show significant improvement with docetaxel addition to ARAT-based regimens, regardless of tumor volume. Further research is needed to identify potential beneficiaries of this combination therapy.

Objective: Clinical trials have demonstrated the efficacy and safety of avelumab + axitinib in patients with advanced clear cell renal cell carcinoma (ccRCC). However, information is limited regarding the activity of avelumab + axitinib in patients with non-clear cell RCC (nccRCC). In Japan, post-marketing surveillance (PMS) of patients with RCC receiving avelumab + axitinib treatment in general clinical practice was undertaken. We report ad hoc analyses of PMS data according to RCC pathological classification.

Methods: Of 328 patients with RCC who received ≥1 dose of avelumab and were enrolled between December 2019 and May 2021, 271 (82.6%) had ccRCC, 22 (6.7%) had nccRCC, and 35 (10.7%) had missing or unknown RCC pathology. Among patients with nccRCC, pathological subtypes were papillary in 12 (3.7%), translocation in 3 (0.9%), acquired cystic disease associated in 3 (0.9%), chromophobe in 2 (0.6%), mucinous tubular and spindle cell in 1 (0.3%), and Bellini duct in 1 (0.3%).

Results: Among patients with ccRCC or nccRCC, any-grade adverse drug reactions of safety specifications occurred in 140 (51.7%) and 15 (68.2%), and of grade ≥3 in 48 (17.7%) and 6 (27.3%), respectively. The objective response rate in patients with ccRCC or nccRCC was 36.9% and 22.7%, respectively; in patients with papillary tumors, it was 33.3%. Median overall survival was not reached in patients with ccRCC or nccRCC, and 12-month overall survival rates were 86.8% and 76.7%, respectively.

Conclusions: Overall, subgroup analyses of PMS data suggest that avelumab + axitinib improved clinical outcomes in nccRCC in addition to ccRCC.

Objectives: The objectives of this study were to analyze trends in prostate cancer incidence, incidence, mortality, and disability-adjusted life years (DALYs) from 1990 to 2021 via data from the Global Burden of Disease (GBD) study in South Asia. Additionally, the study projects future prostate cancer incidence rates up to 2031 to inform public health interventions in South Asia.

Methods: Data covering South Asian countries such as Bangladesh, Bhutan, India, Nepal, and Pakistan were obtained from the GBD 2021 portal. Age-standardized rates (ASRs) for prostate cancer metrics, including incidence (ASIR), prevalence (ASPR), mortality (ASMR), and DALYs (ASDR), were analyzed via joinpoint and ARIMA modeling techniques. Geographic variations in ASRs were mapped via QGIS software.

Results: The prostate cancer ASIR, ASPR, and ASDR significantly increased from 1990 to 2021, particularly among individuals aged 60-65 years. The highest incidence and mortality rates were observed in Pakistan. The total percentage change in incidence in India was the highest at 61%. Projections indicate a continued rise in prostate cancer incidence, with South Asia's ASIR expected to reach 9.34 per 100 000 by 2031.

Conclusions: The growing burden of prostate cancer in South Asia highlights the need for enhanced screening programs, public awareness, and healthcare infrastructure improvements. Without intervention, the increasing incidence and mortality rates could strain healthcare resources, emphasizing the urgency of region-specific public health strategies.

Objectives: To evaluate the safety, efficacy, and patient-reported outcomes of Aquablation therapy using the AQUABEAM Robotic System for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) in a Japanese population.

Methods: This post-market use-results survey included 103 Japanese men with BPH who underwent Aquablation across five centers with previously Aquablation naïve physicians. Data were collected at baseline, during the procedure, at discharge, and at 3 and 6 months post-procedure. Key outcomes included International Prostate Symptom Score (IPSS), quality of life (QoL), uroflowmetry parameters, and adverse events.

Results: The mean age of patients was 71.1 years, and the average prostate size was 82.3 mL. At 6 months, the mean IPSS significantly improved from 18.1 ± 9.0 to 6.1 ± 5.0 (p < 0.0001), and QoL scores improved from 4.9 ± 1.3 to 1.8 ± 1.3 (p < 0.0001). Uroflowmetry showed a significant increase in Qmax from 8.3 ± 4.4 to 15.5 ± 7.8 mL/s (p < 0.0001) and a decrease in post-void residual volume (PVR) from 85.6 ± 107.2 to 43.3 ± 60.0 mL (p = 0.0006). At the 30-day primary safety endpoint, there were no reported adverse events of pad-use incontinence, erectile dysfunction, or ejaculatory dysfunction reported, and no device-related serious adverse events were reported. One subject (0.97%) experienced a Clavien-Dindo grade 3 adverse event.

Conclusions: Aquablation therapy using the AQUABEAM Robotic System is a reproducible, safe, and effective treatment for Japanese men with BPH, providing significant improvements in LUTS and QoL with a favorable safety profile.

Objectives: To evaluate the predictivity of haematologic parameters and HALP score on testicular viability in adults with testicular torsion.

Methods: We retrospectively analyzed the clinical data of 139 men ≥18 years of age who underwent testicular detorsion with fixation (n = 90) or orchiectomy (n = 49) due to testicular torsion in five different tertiary centers between May 2019 and August 2023. Demographic, pre-, peri- and postoperative data were analyzed.

Results: The hemoglobin, albumin, lymphocyte, and platelet (HALP) score in the orchiectomy group was significantly lower compared to the detorsion group (adjusted p = 0.032). Platelet to lymphocyte ratio and duration of torsion were significantly higher in the orchiectomy group (adjusted p = 0.048, adjusted p = 0.000, respectively). Neutrophil-lymphocyte ratio did not reach statistical significance between the groups (adjusted p = 0.074) Furthermore, the orchiectomy group had statistically significantly more heterogeneous echotexture on scrotal ultrasonography (adjusted p = 0.000). On binary logistic regression analysis; platelet-lymphocyte ratio and HALP score were not found as significant predictors for surgical outcome (p = 0.296, p = 0.078, respectively). Multivariate logistic regression analysis revealed that only heterogeneous echotexture on scrotal Doppler ultrasonography and duration of torsion were independent risk factors for testicular necrosis development (p = 0.004, p < 0.001, respectively).

Conclusions: This study demonstrates that heterogeneous echotexture on ultrasound and longer duration of torsion seem to be independent risk factors for testicular necrosis after testicular torsion in adults. However, neither haematologic parameters nor HALP score provided valuable information for testicular viability before scrotal exploration in our series.

Objectives: The aim of the present study was to determine the efficacy and safety of our newly developed ICG-assisted nerve-sparing (NS) robot-assisted radical prostatectomy (RARP) through subjective and objective data.

Methods: This study included 43 NS RARP patients, divided into ICG (23 patients) and non-ICG (20 patients) groups. Immunohistochemical staining with nNOS antibodies was conducted on specimens of resected prostate from the base, middle, and apex to count nNOS-positive cells. Fewer nNOS-positive cells suggested higher quality for the NS procedure. Postoperative erectile function, urinary incontinence, lower urinary tract symptoms (LUTS) as evaluated by the International Prostate Symptom Score (IPSS), and lower urinary tract function were compared between groups, operative time, and adverse events.

Results: Only the number of n-NOS-positive cells at the base differed significantly between the ICG group (15.0 ± 6.9) and the non-ICG group (26.9 ± 21.4, p = 0.02). Regarding LUTS, in the ICG group, significant improvement was only seen in postoperative IPSS scores (13.6 ± 4.9 to 8.7 ± 5.0, p = 0.02). No significant differences in the postoperative erectile function, urinary incontinence, and lower urinary tract function were seen between groups. In addition, significant differences in operative time and rate of adverse events were not observed between groups.

Conclusion: Our innovative approach enhances the visualization of prostatic boundaries, suggesting potential for reliable and straightforward NS procedures, with a significant improvement in LUTS, without evidence of prolonged operative time or an increased frequency of adverse events.

Prostate cancer (PC) growth is hormone-dependent and it frequently develops distant metastases as disease progresses. Patients with metastatic castration-sensitive prostate cancer (mCSPC) initially respond to androgen deprivation therapy (ADT) but eventually become refractory and develop metastatic castration-resistant prostate cancer (mCRPC). Castration-resistance is associated with high lethality and metastases confer poor prognosis, therefore unmet needs in treatment for mCSPC remain high. So far, improvements in survival in mCSPC have been achieved by doublet combination therapy such as docetaxel or an androgen-receptor signaling inhibitor (ARSI) in addition to ADT. Further, recent phase 3 trials have shown that triplet therapy-a combination of ARSI, docetaxel, and ADT improves prognosis compared with docetaxel plus ADT in mCSPC. PC tumors manifest intra- and inter-tumoral heterogeneity at both the genetic and phenotypic level. As heterogeneity increases during sequential treatment and disease progression, it is reasonable to initiate combination therapy using drugs with different mechanisms of action early in the course of disease, such as mCSPC. Previous research about tumor heterogeneity and drug resistant mechanism support this rationale, as well as preclinical studies and real-world data provide the scientific evidence of benefit by combining ARSI and docetaxel. Here, we review the rationale and clinical evidence for triplet therapy in patients with mCSPC.