A phase II, randomized, single-blinded, placebo-controlled clinical trial on the efficacy of Curcumina and Calendula suppositories for the treatment of patients with chronic prostatitis/chronic pelvic pain syndrome type III

Objective: The management of chronic prostatitis/ chronic pelvic pain syndrome type III (CP/CPPS) has been always considered complex due to several biopsychological factors underling the disease. In this clinical study, we aimed to evaluate the efficacy of the treatment with Curcumin and Calendula extract in patients with CP/CPPS III. Material and methods: From June 2015 to January 2016 we enrolled 60 consecutive patients affected by CP/CPPS III in our institution. Patients between 20 and 50 year of age with symptoms of pelvic pain for 3 months or more before study, a total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score ≥ 15 point and diagnosed with NIH category III. Patients were then allocated to receive placebo (Group A) or treatment (Group B). Treatment consisted of rectal suppositories of Curcumin extract 350 mg (95%) and Calendula extract 80 mg (1 suppository/die for 1 month). Patients of Group B received 1 suppository/die for 1 month of placebo. The primary endpoint of the study was the reduction of NIH-CPSI. The secondary outcomes were the change of peak flow, IIEF-5, VAS score and of premature ejaculation diagnostic tool (PEDT). Results: A total of 48 patients concluded the study protocol. The median age of the all cohort was 32.0 years, the median NIH-CPSI was 20.5, the median IIEF-5 was 18.5, the median PEDT was 11.0, the median VAS score was 7.5 and the median peak flow was 14.0. After 3 months of therapy in group A we observed a significant improvement of NIH-CPSI (-5.5; p < 0.01), IIEF-5 (+ 3.5; p < 0.01), PEDT (-6.5; p < 0.01), peak flow (+2.8; p < 0.01) and VAS (-6.5; p < 0.01) with significant differences over placebo group (all p-value significant). Conclusions: In this phase II clinical trial we showed the clinical efficacy of the treatment with Curcumin and Calendula in patients with CP/CPPS III. The benefits of this treatment could be related to the reduction of inflammatory cytokines and of inflammatory cells. These results should be confirmed in further studies with greater sample size

Nephron-sparing surgery in multiple renal cancer: a case report

BACKGROUND: In the last decade, nephron-sparing surgery has largely supplanted the radical approach for the treatment of small renal masses. More recently, ablative technologies have been discussed as alternative in patients that are not eligible for surgical approach.CASE SUMMARY: A 54-year-old Caucasian man was referred to our Urology Clinic for multiple renal masses. A computed tomography (CT) scan revealed three contrast-enhanced lesions located in the upper pole, middle renal, and in the lower pole of the left kidney 20 mm, 25 mm, and 45 mm long, respectively. The patient underwent laparoscopic tumorectomy of two lesions and cryoablation of the left renal mass by the transperitoneal approach, performed without clamping the renal vessels. At the end of the procedure the operator posed a reno-ureteral ipsilateral stent to tutor the urinary tract. Tumor enucleation and cryoablation were chosen to preserve renal function.CONCLUSION: This case report shows that in young patients with multiple renal tumors, cryoablation treatment is feasible and outcomes are promising as well. However, risk of complications should be considered and discussed with patients

A phase II, randomized, single-blinded, placebo-controlled clinical trial on the efficacy of Curcumina and Calendula suppositories for the treatment of patients with chronic prostatitis/chronic pelvic pain syndrome type III

Objective: The management of chronic prostatitis/ chronic pelvic pain syndrome type III (CP/CPPS) has been always considered complex due to several biopsychological factors underling the disease. In this clinical study, we aimed to evaluate the efficacy of the treatment with Curcumin and Calendula extract in patients with CP/CPPS III. Material and methods: From June 2015 to January 2016 we enrolled 60 consecutive patients affected by CP/CPPS III in our institution. Patients between 20 and 50 year of age with symptoms of pelvic pain for 3 months or more before study, a total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score ≥ 15 point and diagnosed with NIH category III. Patients were then allocated to receive placebo (Group A) or treatment (Group B). Treatment consisted of rectal suppositories of Curcumin extract 350 mg (95%) and Calendula extract 80 mg (1 suppository/die for 1 month). Patients of Group B received 1 suppository/die for 1 month of placebo. The primary endpoint of the study was the reduction of NIH-CPSI. The secondary outcomes were the change of peak flow, IIEF-5, VAS score and of premature ejaculation diagnostic tool (PEDT). Results: A total of 48 patients concluded the study protocol. The median age of the all cohort was 32.0 years, the median NIH-CPSI was 20.5, the median IIEF-5 was 18.5, the median PEDT was 11.0, the median VAS score was 7.5 and the median peak flow was 14.0. After 3 months of therapy in group A we observed a significant improvement of NIH-CPSI (-5.5; p < 0.01), IIEF-5 (+ 3.5; p < 0.01), PEDT (-6.5; p < 0.01), peak flow (+2.8; p < 0.01) and VAS (-6.5; p < 0.01) with significant differences over placebo group (all p-value significant). Conclusions: In this phase II clinical trial we showed the clinical efficacy of the treatment with Curcumin and Calendula in patients with CP/CPPS III. The benefits of this treatment could be related to the reduction of inflammatory cytokines and of inflammatory cells. These results should be confirmed in further studies with greater sample size

Percentage of cancer involvement in positive cores can predict unfavorable disease in men with low-risk prostate cancer but eligible for the prostate cancer international: active surveillance criteria

Objectives: To identify predictive factors of unfavorable disease and of biochemical failure in patients treated with radical prostatectomy but eligible for active surveillance (AS) according to Prostate Cancer Research International: Active Surveillance (PRIAS) criteria. We aimed to introduce and validate the percentage of cancer involvement in positive cores (CIPC) as potential worse predictive factor. Methods: From January 2002 to December 2007, 750 consecutive subjects underwent radical prostatectomy at a single institution. We identified 147 (19.05%) patients who were eligible for AS based on PRIAS criteria: clinical stage T1c or T2 disease, prostate-specific antigen level of≤10 ng/ml, Gleason score≤6, prostate-specific antigen-D of&lt;0.2 ng/ml2, and fewer than 3 positive biopsy cores. CIPC was included in the analysis. Results: Of the 147 patients, 95 (66.43%) patients had favorable disease, whereas 48 (33.57%) had unfavorable disease. In multivariate logistic regression, maximum cancer length (odds ratio 12.52, P&lt;0.01) and CIPC (odds ratio 1.70, P&lt;0.01) represented independent predictors of unfavorable prostate cancer. The area under the receiver operating characteristics curve analysis revealed significantly higher performance after including CIPC to the PRIAS criteria (0.61 vs. 0.94, P&lt;0.01). A cutoff of 0.4 mm of CIPC was set to predict unfavorable disease with 93% specificity, 76% sensibility, and 87% accuracy based on the receiver operating characteristics curve analysis. Finally, the 3- and 5-years biochemical recurrence (BCR)-free survival were significantly lower in subjects with CIPC≥0.4 mm, 88.4 % and 81.0% vs. 97.8% and 95.7%, respectively (P&lt; 0.01). Conclusions: Our findings suggest that the inclusion of CIPC to the prostate biopsy features could be helpful to avoid misclassification in patients eligible for AS according to the PRIAS criteria.</br

Neutrophil to lymphocyte ratio, a biomarker in non-muscle invasive bladder cancer: a single-institutional longitudinal study

ABSTRACT Background: Bladder cancer represents one of the most important clinical challenges in urologic practice. In this context, inflammation has an important role in the development and progression of many malignancies. The objective of the present study was to evaluate the prognostic value of pre-treatment Neutrophil to lymphocyte ratio (NLR) on the risk of recurrence and progression in patients with primary non-muscle invasive bladder cancer. Materials and Methods: Data obtained from 178 bladder cancer patients who underwent transurethral resection of bladder tumor (TURB) between July 2008 and December 2014 were evaluated prospectively. NLR was obtained from each patient before TURB and defined as the absolute neutrophil count divided by the absolute lymphocyte count. Cox proportional hazards regression model was performed to calculate disease recurrence and progression including NLR. Results: During the follow-up study (median: 53 months), 14 (23.3%) and 44 (37.9%) (p=0.04) patients respectively with NLR<3 and ≥3experienced recurrence and 2 (3.3%) and 14 (11.9%) experienced progression (p=0.06), respectively. At the multivariate Cox regression analysis, NLR ≥3 was associated with worse disease recurrence (HR: 2.84; p<0.01). No association was found regarding disease progression. The 5-year recurrence free survival was 49% and 62% in patients with NLR≥3 and <3 (p<0.01). The 5-year progression free survival was 77% and 93% in patients with NLR≥3 and <3 (p=0.69). Conclusion: NLR predicts disease recurrence but not disease progression in NMIBC patients. NLR alterations may depend of tumor inflammatory microenvironment

Prevalence of intratubular germ cell neoplasia and multifocality in testicular germ cell tumors &#8804; 2 cm: relationship with other pathological features

Introduction: The aim of this study was to determine the prevalence of TIN and multifocality in men undergoing radical orchiectomy for testicular germ cell tumor (TGCT), and among those with a main tumor size &#8804; 2 cm, potentially eligible for testis-sparing surgery. Patients and Methods: Orchiectomy specimens from 126 consecutive patients treated for TGCT tumor between 2003 and 2012 were included. Multifocality was defined as a distinct tumor focus with a diameter &#8805; 1 mm separable from the main tumor mass. Uni- and multivariate logistic regression was performed to identify the association between pathological variables and multifocality and to identify variables for predicting clinical stage II to III and pathological stage &#8805; pT2. Results: Of the 126 patients, 103 (82.0%) had clinical stage I cancer at presentation and 23 (18.0%) had clinical stage II to III. The median size of the primary tumor mass was 3.7 cm (range, 0.5-12 cm) in multifocality and 3.0 cm (range, 0.6-8.0 cm) in monofocality, respectively (P &lt; .05). The prevalence of multifocality and TIN was lower in the presence of a smaller main tumor mass (&#8804; 1 cm) compared with tumors 1.1 to 2.0 cm (P &lt; .05), and increased when the index mass tumor diameter was &#8805; 2 cm (P trend &lt; .05). No association was found between tumor histology and multifocality (P = .95) or TIN (P = .54) using the χ2 test. Conclusion: The prevalence of multifocality and TIN was decreased in smaller tumors (&#8804; 1 cm) and increased when the index mass tumor diameter was &#8805; 1.1 cm

Contrasted resistance of stone-dwelling Geodermatophilaceae species to stresses known to give rise to reactive oxygen species

Stones in arid environments are inhabited by actinobacteria of the family Geodermatophilaceae like the genera Blastococcus and Modestobacter frequently isolated from altered calcarenites. Their habitat requires adaptation to light-induced and other stresses that generate reactive oxygen species. Here, we show that representative members of the species Blastococcus saxobsidens, Geodermatophilus obscurus, and Modestobacter multiseptatus are differentially adapted to stresses associated with arid environments. Whereas B. saxobsidens was found to be sensitive to gamma radiation (D10 = 900 Gy; 10% survival at 900 Gy), M. multiseptatus was moderately (D10 = 6000 Gy) and G. obscurus was highly tolerant (D10 = 9000 Gy). A difference in resistance to high-frequency (λ value = 254 nm) UV was shown by B. saxobsidens, M. multiseptatus, and G. obscurus, being sensitive, tolerant, and highly tolerant (D10 of 6, 900, and > 3500 kJ m-2, respectively). Tolerance to desiccation, mitomycin C and hydrogen peroxide correlated with the ionizing radiation and UV resistance profiles of the three species and were correlated with the pigments synthesized. Resistance to heavy metals/metalloids did not follow the same pattern, with resistance to Ag2+ and Pb2+ being similar for B. saxobsidens, M. multiseptatus, and G. obscurus, whereas resistance to AsO4 3-, Cr2+, or Cu2+ was greater for B. saxobsidens than for the other two species. The stress resistance profiles of M. multiseptatus and B. saxobsidens were reflected in different calcarenite colonization patterns. While M. multiseptatus was predominantly isolated from the first two millimeters of stone surface, B. saxobsidens was predominantly isolated from the deeper part of the stone where it is better protected from sun irradiation, suggesting that the response to light- and desiccation-induced oxidative stress is an important driver for niche colonization in the stone biotope. © 2012 Federation of European Microbiological Societies. Published by Blackwell Publishing Ltd. All rights reserved

Predicting survival in node-positive prostate cancer after open, laparoscopic or robotic radical prostatectomy: A competing risk analysis of a multi-institutional database

Objectives: To investigate cancer-specific mortality and other-cause mortality in prostate cancer patients with nodal metastases. Methods: The study included 411 patients treated with radical prostatectomy and pelvic lymph node dissection for prostate cancer with lymph node metastases at 10 tertiary care centers between 1995 and 2014. Kaplan–Meier analyses were used to assess cancer-specific mortality-free survival rates at 8 years' follow up in the overall population, and after stratifying patients according to clinical and pathological parameters. Uni- and multivariable competing risk Cox regression analyses were used to assess cancer-specific mortality and other-cause mortality. Finally, cumulative-incidence plots were generated for cancer-specific mortality and other-cause mortality after stratifying patients according to the number of positive lymph nodes and the median age at surgery, according to the competing risks method. Results: Men with prostate-specific antigen ≤40 ng/mL and those with one to three positive lymph nodes showed higher cancer-specific mortality-free survival estimates as compared with their counterparts with prostate-specific antigen >40 ng/mL and >3 metastatic lymph nodes, respectively (all P 40 ng/mL, >3 lymph node metastases and pathological Gleason score 8–10 were all independent predictors of cancer-specific mortality (all P-values ≤0.001). On competing risk analysis, when patients were stratified according to the number of positive lymph nodes (namely, ≤3 vs >3), the 8-year cancer-specific mortality rates were 27.4% versus 44.8% for patients aged 3 positive lymph nodes, the overall mortality rate is completely related to prostate cancer in young patients. © 2016 The Japanese Urological Associatio