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Aim: The COVID-19 has dramatically stressed the Italian health system. The management of cancers of the urinary and male genital tracts must be adapted to this context. Material and Method: were analysed operator data of cancer patients treated during outbreaks. Results: The medical and surgical management of patients with any cancers of the urinary and male genital tracts must be adapted by modifying the consultation methods, by prioritizing interventions according to the intrinsic prognosis of cancers, taking into account the patient's comorbidities. The protection of urologists from COVID-19 must be considered. Conclusion: Our study shows that with due precautions and with the right patient choice, urological surgical procedures can also be performed during the covid period and that robotic surgery is preferable as a therapeutic choice.

Background Previously published preliminary findings showed promising activity of paclitaxel in chemotherapy-pretreated metastatic penile cancer. Objective To evaluate the activity and safety of paclitaxel in pretreated metastatic penile cancer. Design, setting, and participants Twenty-five patients were enrolled in a single-arm phase 2 multicentre study and treated with 175mg/m 2 paclitaxel at 3-wk intervals until disease progression or irreversible toxicity. Measurements The objective response rate was the primary end point. Safety, progression-free survival (PFS), and overall survival (OS) were secondary end points. Results and limitations Partial responses were observed in 20% (5 of 25 patients). Grade 1–2 neutropenia, nausea, and oral mucositis were the most common side effects, noted in 13, 9, and 8 patients, respectively. Grade 3–4 neutropenia was reported in seven patients (28%). Median PFS was 11 wk (95% confidence interval [CI], 7–30); median OS was 23 wk (95% CI, 13–48). Median survival in responders was 32 wk (95% CI, 20–48). One limitation of our study was the limited accrual, which did not reach the target of 27 patients, due to the typical slow enrolment of a rare disease. Conclusions Final results of this study demonstrate that paclitaxel is moderately active and well tolerated. Further trials, which may also explore the combination of paclitaxel with other agents, are required to confirm our findings.

Recently, many studies explored the role of inflammation parameters in the prognosis of urinary cancers, but the results were not consistent. The modified Glasgow Prognostic Score (mGPS), a systemic inflammation marker, is a prognostic marker in various types of cancers. The aim of the present study was to investigate the usefulness of the preoperative mGPS as predictor of recurrence-free (RFS), overall (OS), and cancer-specific (CSS) survivals in a large cohort of urothelial bladder cancer (UBC) patients.A total of 1037 patients with UBC were included in this study with a median follow-up of 22 months (range 3-60 months). An mGPS = 0 was observed in 646 patients (62.3%), mGPS = 1 in 297 patients (28.6 %), and mGPS = 2 in 94 patients (9.1%).In our study cohort, subjects with an mGPS equal to 2 had a significantly shorter median RFS compared with subjects with mGPS equal to 1 (16 vs 19 months, hazard ratio [HR] 1.54, 95% CI 1.31-1.81, P < 0.001) or with subjects with mGPS equal to 0 (16 vs 29 months, HR 2.38, 95% CI 1.86-3.05, P < 0.001). The association between mGPS and RFS was confirmed by weighted multivariate Cox model. Although in univariate analysis higher mGPS was associated with lower OS and CSS, this association disappeared in multivariate analysis where only the presence of lymph node-positive bladder cancer and T4 stage were predictors of worse prognosis for OS and CSS.In conclusion, the mGPS is an easily measured and inexpensive prognostic marker that was significantly associated with RFS in UBC patients.

PURPOSE: The body mass index (BMI) may be associated with an increased incidence and aggressiveness of urological cancers. In this study, we aimed to evaluate the impact of the BMI on survival in patients with T1G3 non-muscle-invasive bladder cancer (NMIBC). METHODS: A total of 1155 T1G3 NMIBC patients from 13 academic institutions were retrospectively reviewed and patients administered adjuvant intravesical Bacillus Calmette-Guérin (BCG) immunotherapy with maintenance were included. Multivariable Cox regression analysis was performed to identify factors predictive of recurrence and progression. RESULTS: After re-TURBT, 288 patients (27.53%) showed residual high-grade NMIBC, while 867 (82.89%) were negative. During follow-up, 678 (64.82%) suffered recurrence, and 303 (30%) progression, 150 (14.34%) died of all causes, and 77 (7.36%) died of bladder cancer. At multivariate analysis, tumor size (hazard ratio [HR]:1.3; p = 0.001), and multifocality (HR:1.24; p = 0.004) were significantly associated with recurrence (c-index for the model:55.98). Overweight (HR: 4; p, M.D.V is supported by the Scholarship Foundation of the Republic of Austria—OeAD and by the EUSP Scholarship— European Association of Urology, info:eu-repo/semantics/publishedVersion

Background: Serum levels of neutrophils, platelets, and lymphocytes have been recognized as factors related to poor prognosis for many solid tumors, including bladder cancer (BC). Objective: To evaluate the prognostic role of the combination of the neutrophil/lymphocyte ratio (NLR), platelet/lymphocyte ratio (PLR), and lymphocyte/monocyte ratio (LMR) in patients with high-risk non–muscle-invasive urothelial BC (NIMBC). Design, setting, and participants: A total of 1151 NMIBC patients who underwent first transurethral resection of the bladder tumor (TURBT) at 13 academic institutions between January 1, 2002 and December 31, 2012 were included in this analysis. The median follow-up was 48 mo. Intervention: TURBT with intravesical chemotherapy or immunotherapy. Outcome measurements and statistical analysis: Multivariable Cox regression analysis was performed to identify factors predictive of recurrence, progression, cancer-specific mortality, and overall mortality. A systemic inflammatory marker (SIM) score was calculated based on cutoffs for NLR, PLR, and LMR. Results and limitations: The 48-mo recurrence-free survival was 80.8%, 47.35%, 20.67%, and 17.06% for patients with an SIM score of 0, 1, 2, and 3, respectively (p < 0.01, log-rank test) while the corresponding 48-mo progression free-survival was 92.0%, 75.67%, 72.85%, and 63.1% (p < 0.01, log-rank test). SIM scores of 1, 2, and 3 were associated with recurrence (hazard ratio [HR] 3.73, 7.06, and 7.88) and progression (HR 3.15, 4.41, and 5.83). Limitations include the lack of external validation and comparison to other clinical risk models. Conclusions: Patients with high-grade T1 stage NMIBC with high SIM scores have worse oncologic outcomes in terms of recurrence and progression. Further studies should be conducted to stratify patients according to SIM scores to identify individuals who might benefit from early cystectomy. Patient summary: In this study, we defined a risk score (the SIM score) based on the measurement of routine systemic inflammatory markers. This score can identify patients with high-grade bladder cancer not invading the muscular layer who are more likely to suffer from tumor recurrence and progression. Therefore, the score could be used to select patients who might benefit from early bladder removal. Patients with high-risk non–muscle-invasive bladder cancer (BC) experienced greater recurrence and progression according to systemic inflammatory markers. This score could be used to select patients who might benefit from early cystectomy. The availability of these biomarkers in routine clinical practice gives further relevance to identification of the prognostic role of immune cells in patients with BC. These results could be translated into clinical practice to stratify patients who might benefit from early cystectomy.

The aim of this multi-institutional study was to identify predictors of residual high-grade (HG) disease at re-transurethral resection (reTUR) in a large cohort of primary T1 HG/Grade 3 (G3) bladder cancer patients. A total of 1155 patients with primary T1 HG/G3 bladder cancer from 13 academic institutions that underwent a reTUR within 6 weeks after first TUR were evaluated. Logistic regression analysis was performed to assess the association of predictive factors with residual HG at reTUR. Residual HG cancer was found in 288 (24.9%) of patients at reTUR. Patients presenting residual HG cancer were more likely to have carcinoma in situ (CIS) at first resection (p=25 kg/m2. On multivariable analysis, independent predictors for HG residual disease at reTUR were tumor size >3cm (OR = 1.37; 95% CI: 1.02-1.84, p=0.03), concomitant CIS (OR 1.92; 95% CI: 1.32-2.78, p=0.001), being overweight (OR= 2.08; 95% CI: 1.44-3.01, p=25 kg/m2., This study was supported by "Fondazione Muto", Naples-Italy. M.D.V is supported by the Scholarship Foundation of the Republic of Austria OeAD and by the EUSP Scholarship - European Association of Urology., info:eu-repo/semantics/publishedVersion

The aim of this multicenter study was to investigate the prognostic impact of residual T1 high-grade (HG)/G3 tumors at re-transurethral resection (TUR of bladder tumor) in a large multi-institutional cohort of patients with primary T1 HG/G3 bladder cancer (BC)., M.D.V is supported by the Scholarship Foundation of the Republic of Austria - OeAD and by the EUSP Scholarship - EAU., info:eu-repo/semantics/publishedVersion

Radical cystectomy (RC) remains a surgical procedure with significant morbidity. Our retrospective cohort study, based on a standardized complications reporting system, shows that RC is associated with 19.2% of high grade early complications and 1.7% of death rate. Metabolic syndrome (MetS) and, separately, waist circumference represent independent risk factors for high-grade complications (odds ratio [OR], 1.3; P = .010 and OR, 1.9; P = .022, respectively). Introduction/Background: The objective of this study was to evaluate the effect of MetS and its components on the early complications observed in patients treated with RC and urinary diversion. Patients and Methods: We retrospectively analyzed 346 patients with bladder cancer undergoing RC with standard lymphadenectomy, according to the procedure suggested by the International Consultation on Bladder Cancer, and urinary diversion. All early complications within 90 days of surgery were recorded and collected according to the 10 Martin criteria and classified according to the established 5 grades of the modified Clavien classification system (CCS). MetS was defined according to the National Cholesterol Educational Program's Third Adult Treatment Panel. A binary logistic regression analysis was used to analyze MetS and, separately, its single components, as possible independent risk factors for high-grade complications. Results: A total of 323 complications occurred in 231 of 346 patients (66.8%). The rates for low-grade (CCS I-II) and high-grade complications (CCS III-V), and mortality within 90 days (CCS V), were 80.8% (261 of 323), 19.2% (62 of 323), and 1.7% (6 of 346), respectively. At univariate analysis, MetS patients showed a higher rate of high-grade complications compared with patients without MetS (P < .001). At binary logistic regression analysis, MetS (OR, 1.3; P = .010), waist circumference (OR, 1.9; P = .022) and, only in single model, urinary diversion (OR, 1.3; P = .024) were independent risk factors for high-grade complications. Conclusion: RC is a major surgical procedure with a significant early complications rate, nevertheless, most are low-grade complications. MetS and, separately, waist circumference are associated with high-grade complications.

CONTEXT: Over the last decade, robot-assisted adrenalectomy has been included in the surgical armamentarium for the management of adrenal masses. OBJECTIVE: To critically analyze the available evidence of studies comparing laparoscopic and robotic adrenalectomy. EVIDENCE ACQUISITION: A systematic literature review was performed in August 2013 using PubMed, Scopus, and Web of Science electronic search engines. Article selection proceeded according to the search strategy based on Preferred Reporting Items for Systematic Reviews and Meta-analysis criteria. EVIDENCE SYNTHESIS: Nine studies were selected for the analysis including 600 patients who underwent minimally invasive adrenalectomy (277 robot assisted and 323 laparoscopic). Only one of the studies was a randomized clinical trial (RCT) but of low quality according to the Jadad scale. However, the methodological quality of included nonrandomized studies was relatively high. Body mass index was higher for the laparoscopic group (weighted mean difference [WMD]: -2.37; 95% confidence interval [CI], - 3.01 to -1.74; p

Introduction To evaluate the applicability of a modified Clavien classification system (CCS) in grading postoperative complications of transurethral resection of bladder tumours (TURB). Materials and methods A series of patients undergoing monopolar TURB from April 2011 to March 2012 at five Italian centers were enrolled. All complications occurring within the first 30-day postoperative period were prospectively recorded and graded according to the CCS. Results Overall, 275 patients were included. Median age was 71 (63/78) years; median BMI was 28 (25.4/30.8) Kg/m2, median tumour size was 2 (1–3) cm; median number of tumour lesions was 1 (1–3). Median operative time was 30 (20/45) min. Fifty-seven complications were recorded in 43 patients. Overall postoperative morbidity rate was 16%. Most of the complications were not serious and classified as Clavien type I (42 cases; 74%) or II (8 cases, 14%). Higher grade complications were scarce: CCS IIIa in 1 case (2%) and CCS IIIb in six cases (10%). No TURB related death was reported. Six patients were re-operated due to significant bleeding or clot retention on postoperative days 2–7. On univariate (73.5 ± 38 versus 36.7 ± 21.6 min) and multivariate analysis longer operative time was an independent predictor of complications (OR: 1.06 per min, 95%CI 1.04–1.08, p = 0.001). Conclusions A modified CCS can be used as a standardized tool to objectively define the complications of TURB which confirms to be a safe procedure with a low surgical morbidity. This tool can be used to aid in patient counselling and to facilitate scientific assessment.

Axitinib is an oral angiogenesis inhibitor, currently approved for treatment of metastatic renal cell carcinoma (mRCC) after failure of prior treatment with Sunitinib or cytokine. The present study is an Italian Multi-Institutional Retrospective Analysis that evaluated the outcomes of Axitinib, in second-line treatment of mRCC. The medical records of 62 patients treated with Axitinib, were retrospectively reviewed. The Progression Free Survival (PFS), the Overall Survival (OS), the Objective Response Rate (ORR), the Disease Control Rate (DCR), and the safety profile of axitinib and sunitinib–axitinib sequence, were the primary endpoint. The mPFS was 5.83 months (95% CI 3.93–7.73 months). When patients was stratified by Heng score, mPFS was 5.73, 5.83, 10.03 months according to poor, intermediate, and favorable risk group, respectively. The mOS from the start of axitinib was 13.3 months (95% CI 8.6–17.9 months); the observed ORR and DCR were 25 and 71%, respectively. When stratified patients by subgroups defined by duration of prior therapy with Sunitinib (≤ vs. >median duration), there was a statistically significant difference in mPFS with 8.9 (95% CI 4.39–13.40 months) vs. 5.46 months (95% CI 4.04–6.88 months) for patients with a median duration of Sunitinib >13.2 months. DCR and ORR to previous Sunitinib treatment was associated with longer statistically mPFS, 7.23 (95% CI 3.95–10.51 months, p = 0.01) and 8.67 (95% CI 4.0–13.33 months, p = 0.008) vs. 2.97 (95% CI 0.65–5.27 months, p = 0.01) and 2.97 months (95% CI 0.66–5.28 months, p = 0.01), respectively. Overall Axitinib at standard schedule of 5 mg bid, was well-tolerated. The most common adverse events of all grades were fatig (25.6%), hypertension (22.6%), gastro-intestinal disorders (25.9%), and hypothyroidism (16.1%). The sequence Sunitinib–Axitinib was well-tolerated without worsening in side effects, with a median OS of 34.7 months (95% CI 18.4–51.0 months). Our results are consistent with the available literature; this retrospective analysis confirms that Axitinib is effective and safe in routine clinical practice.

Docetaxel represents the first-line treatment for castration-resistant prostate cancer (CRPC). New therapeutic options are needed for subsequent lines of therapy in CRPC patients. Patients with progressive CRPC, pretreated with docetaxel, were enrolled at the Department of Molecular and Clinical Oncology and Endocrinology of University ‘Federico II of Naples’ from April 2007 to January 2010. Accrued patients received cisplatin at the dose of 75 mg/m2 every 3 weeks with daily 10 mg prednisone. Measures of response and progression were defined according to the Prostate Cancer Working Group (PCWG1) criteria. Toxicity was graded according to the Common Toxicity Criteria of the National Cancer Institute, version 3.0. Twenty-five patients were recruited. Median age was 65 years (interquartile range 55–74 years). All patients were evaluable for PSA response and toxicity and thirteen patients (52%) were evaluable for measurable disease. A total of 170 cycles of cisplatin chemotherapy were administered. Median dose intensity corresponded to 96% (range 83.8–98.3%) of the maximum dose intensity that could be delivered. Three patients (12%) presented grade 3–4 neuropathy and ten (40%) presented grade 3–4 neutropenia. Five patients (20%) showed a greater than 50% PSA decline, and three of thirteen patients with measurable disease presented a partial response. Median progression-free survival was 5.6 months (24 weeks; range 15–24). Median survival was 55 weeks (range 46–64; see Fig. 1). Cisplatin plus prednisone appears to represent an active regimen in docetaxel-refractory CRPC with an acceptable toxicity profile. Further investigations in this setting are warranted to confirm these early encouraging findings.

The objective of this study was to evaluate intravesical gemcitabine in high-risk nonmuscle-invasive bladder cancer (NMIBC) refractory to bacillus Calmette-Guérin (BCG). This was a prospective multicentre single-arm trial. Eligible patients were those with high-risk NMIBC refractory to BCG therapy, for which radical cystectomy was indicated but not conducted because of patient refusal or ineligibility. Patients received intravesical gemcitabine twice weekly at a dose of 2000 mg/50 ml for 6 weeks, and then weekly for 3 weeks at 3, 6, and 12 months. Outcome measures were recurrence rate, time to first recurrence, progression rate and complications. Twenty patients were enrolled and included in the analysis. Median follow-up was 15.2 months. Fifty-five percent (11 patients) developed disease recurrence. Mean time to the first recurrence was 3.5 months and 45% (five patients) of recurring patients had disease progression. Overall, treatment was well tolerated. Urinary symptoms represented the primary adverse events. The role of gemcitabine used as second-line treatment in high-risk BCG-refractory NMIBC patients who refused or were unsuitable for radical cystectomy remains to be defined. Further clinical research in this area is needed.

Objectives To review all relevant features of incidentally discovered prostate cancer (PCa) in patients undergoing radical cystectomy for bladder cancer: incidence, pathologic characteristics, clinical significance, and implications for its management. Methods A structured literature review through a MEDLINE search was performed. Results The frequency of incidentally discovered PCa in cystoprostatectomy specimens is extremely variable because of several factors, particularly the pathology sampling. The relationship among clinically, incidentally, and autopsy-detected cancer is uncertain. The definition of clinically significant cancer varies among published reports and remains inadequate for clinical application. High-grade prostatic intraepithelial neoplasia is a marker for concurrent PCa and the risk depends more on the volume than on its absolute presence. Outcome of patients with unsuspected PCa after cystoprostatectomy relies mostly on the bladder tumor. Conclusions Incidental PCa in patients with bladder cancer is highly variable and with an unclear clinical significance. For those who are candidates for prostate-sparing surgery, it seems reasonable to include a routine prostate biopsy in the standard preoperative work-up irrespective of prostate-specific antigen values. In the absence of sufficient data to make firm recommendations, when PCa is incidentally discovered, PCa surveillance should be part of the follow-up scheme after radical cystectomy.

Aim: A higher Gleason score was associated with a lower tumor urotensin II receptor (UTII-R) expression in prostate cancer patients. Methods: A retrospective review of formalin-fixed paraffin-embedded tumor tissue derived from those who had prostatectomy and matching biopsy specimens was conducted at six Institutions. UTII-R expression was evaluated on biopsy by immunohistochemistry. Results: A total of 58 subjects undergoing radical prostatectomy were included. At multivariate analysis, low UTII-R expression was a significant predictor of Gleason upgrading, with an odds ratio of 10.3 (95% CI: 1.55–68.4), and of pathology upstaging, with an odds ratio of 11.1 (95% CI: 1.23–100.48). Conclusions: UTII-R expression on biopsy was associated with Gleason upgrading and pathology upstaging in prostate cancer patients.

There is growing interest among urologists on the need for decreasing pain during transrectal ultrasound (TRUS) guided prostate biopsy.We performed a systematic MEDLINE search of clinical trials of any kind of anesthesia, analgesia or sedation during TRUS guided prostate biopsy published since 2000. We critically analyzed the impact of pain and discomfort associated with the procedure, the described methods for evaluating it and the different techniques that have been described.There is strong evidence in the current literature that patient tolerance and comfort during TRUS guided prostate biopsy can be improved by anesthesia/analgesia. What remains is the need to urge all urologists to introduce it in clinical practice as a routine part of the procedure, whatever the biopsy scheme.Of the various options periprostatic anesthetic infiltration has been shown to be safe, easy to perform and highly effective. It should be considered the gold standard at the moment, even if the optimal technique remains to be established. Further studies addressing this issue are warranted.

Solitary metastases to the small bones and/or to the soft tissue of the hands and feet (acrometastases) are rare. We report a case of renal cell carcinoma (RCC) with big toe metastasis revealed before the primary tumor became apparent. The best treatment for a single metastasis is always surgical excision, regardless of the lesion being synchronous or metachronous. The biological behavior of metastatic RCC is unpredictable and only early diagnosis and treatment may favorably affect patient survival. Thus, metastatic RCC should be included in the differential diagnosis of all enlarging cutaneous nodules, wherever they develop.

Background: The current study investigated the clinical benefit, the impact on biochemical and objective response and tolerability of weekly docetaxel with vinorelbine (VIN-DOX) in symptomatic patients with hormone refractory prostate cancer (HRPC). Methods: Patients were treated with docetaxel 25mg/m 2 and vinorelbine 20mg/m 2 , intravenously for 6 consecutive weeks followed by a 2 week rest repeatedly until disease progression. Clinical benefit evaluations, based on Karnofsky performance status (KPS) and pain measure, were assessed weekly during therapy. A clinical benefit response was defined as a sustained (≥4 weeks) improvements in one of these parameters. Changes in prostate-specific antigen (PSA) levels, tumoral response and toxicity also were evaluated. Results: 19 men (median age 68 years), were treated. Overall, 42% of patients achieved a KPS significant change and positive pain response; 47% achieved a 50% or greater reduction in PSA. The objective response rate was observed in 2 of 9 patients with measurable disease (22%). The most important toxicity was neutropenia (Grade 3=32%). Conclusions: The combination of weekly VIN-DOX appears to be feasible. VIN-DOX was found to be associated with improvement in clinical benefit response and biochemical response and well tolerated as first line treatment in HRPC.

Purpose: To evaluate the pathological characteristics of patients with metabolic syndrome (MetS) undergoing radical cystectomy (RC) for urothelial bladder cancer (BCa). Methods: We retrospectively analyzed 262 consecutive patients with muscle-invasive urothelial BCa or non-muscle-invasive urothelial BCa bacillus Calmette-Guerin refractory undergoing RC with standard pelvic lymphadenectomy. The patients were stratified into those with or without MetS, and a bivariate logistic regression analysis was done to assess MetS and, separately, each single MetS component as independent predictors of higher pathological stage as well as of the presence of lymph vascular invasion (LVI) and lymph node metastasis (LM). Results: Metabolic syndrome was found in 36.3 % of patients. At logistic regression analysis, the presence of MetS did not predict the risk of both higher pathological stage and LVI and LM. Investigating the single components of MetS after adjusting for age, gender, and smoking, the risk of higher pathological stage increased with body mass index [BMI (OR 1.307, 95 % CI 1.098-1.555)], waist circumference (OR 1.414, 95 % CI 1.364-1.668), and blood hypertension (OR 2.326, 95 % CI 1.147-4.717). Higher BMI also predicted the presence of LVI (OR 1.432, 95 % CI 1.173-1.748) and LM (OR 1.202, 95 % CI 0.951-1.519), whereas HDL cholesterol was inversely associated with the risk of LVI and LM. Conclusions: Metabolic syndrome does not represent an independent risk factor for worse pathological findings in BCa. Conversely, individual components of MetS could increase the risk of higher stage as well as LM. © 2013 Springer-Verlag Berlin Heidelberg.

Many efforts to reduce prostate specific antigen (PSA) overdiagnosis and overtreatment have been made. To this aim, Prostate Health Index (Phi) and Prostate Cancer Antigen 3 (PCA3) have been proposed as new more specific biomarkers. We evaluated the ability of phi and PCA3 to identify prostate cancer (PCa) at initial prostate biopsy in men with total PSA range of 2-10 ng/ml. The performance of phi and PCA3 were evaluated in 300 patients undergoing first prostate biopsy. ROC curve analyses tested the accuracy (AUC) of phi and PCA3 in predicting PCa. Decision curve analyses (DCA) were used to compare the clinical benefit of the two biomarkers. We found that the AUC value of phi (0.77) was comparable to those of %p2PSA (0.76) and PCA3 (0.73) with no significant differences in pairwise comparison (%p2PSA vs phi p = 0.673, %p2PSA vs. PCA3 p = 0.417 and phi vs. PCA3 p = 0.247). These three biomarkers significantly outperformed fPSA (AUC = 0.60), %fPSA (AUC = 0.62) and p2PSA (AUC = 0.63). At DCA, phi and PCA3 exhibited a very close net benefit profile until the threshold probability of 25%, then phi index showed higher net benefit than PCA3. Multivariable analysis showed that the addition of phi and PCA3 to the base multivariable model (age, PSA, %fPSA, DRE, prostate volume) increased predictive accuracy, whereas no model improved single biomarker performance. Finally we showed that subjects with active surveillance (AS) compatible cancer had significantly lower phi and PCA3 values (p < 0.001 and p = 0.01, respectively). In conclusion, both phi and PCA3 comparably increase the accuracy in predicting the presence of PCa in total PSA range 2-10 ng/ml at initial biopsy, outperforming currently used %fPSA.

Background The use of magnetic resonance spectroscopy imaging (MRSI) and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) have emerged as a valid diagnostic tools for prostate cancer (CaP). Methods Men with PSA levels below 10 ng/ml were enrolled in a prospective cohort study and underwent combined MRSI and DCE-MRI and transrectal ultrasound-guided prostate biopsy. Imaging was performed using a 1.5 T MR scanner (Symphony TIM; Siemens, Erlangen, Germany) with an endorectal coil (Medrad; Pittsburg, PA), inflated with 60 cc of air. Three-dimensional magnetic resonance spectroscopic data were acquired by using water and a lipid-suppressed double-spin-echo point-resolved spectroscopy sequence, which was optimized for quantitative detection of both choline and citrate. Dynamic contrast-enhanced MRI sequences were obtained with 3D T1-weighted FLASH images before and during rapid bolus administration of intravenous paramagnetic contrast medium gadoteric acid. Specificity, sensitivity, positive predictive value, negative predictive value, and accuracy were computed considering patients, each of the 2 lobes, each of the 6 sextants, and each 12th part of the prostate gland as single measurements. Results Overall, 106 patients were included in the analysis. Median age was 65.9 years (range, 61.2–70.5 years) and median PSA level at study entry was 7.1 ng/ml (range, 2.5–9.9). CaP was detected at biopsy in 24 patients (22.6 % of the population) with a median Gleason score of 8 (range 4–10). Diagnostic accuracy of combined MRSI and DCE-MRI was 85%, sensitivity was 71%, and specificity was 48%, considering patients as single measurements, with a negative predictive value of 91%, but a positive predictive value of only 19%. Positive predictive value of the examination improved to 25% for patients who repeated biopsy. Conclusions Although this study confirms the potential usefulness of MRI for the diagnosis of CaP, the positive predictive value obtained was unacceptably low due to the high number of false positives recorded. Nevertheless, the high negative predictive value of the examination may serve to avoid unnecessary biopsies. Future research should be directed at assessing the value of combining MRI-based techniques with novel biochemical markers for the diagnosis of CaP in patients with low PSA levels.

Indication for prostate biopsy is presently mainly based on prostate-specific antigen (PSA) serum levels and digital-rectal examination (DRE). In view of the unsatisfactory accuracy of these two diagnostic exams, research has focused on novel markers to improve pre-biopsy prostate cancer detection, such as phi and PCA3. The purpose of this prospective study was to assess the diagnostic accuracy of phi and PCA3 for prostate cancer using biopsy as gold standard. Phi index (Beckman coulter immunoassay), PCA3 score (Progensa PCA3 assay) and other established biomarkers (tPSA, fPSA and %fPSA) were assessed before a 18-core prostate biopsy in a group of 251 subjects at their first biopsy. Values of %p2PSA and phi were significantly higher in patients with PCa compared with PCa-negative group (p

BACKGROUND: The efficacy of intravesical gemcitabine was evaluated compared with repeated administration of bacille Calmette-Guerin (BCG) after BCG failure in high-risk, non-muscle-invasive bladder cancer (BC). METHODS: In this multicenter, prospective, randomized, phase 2 trial, eligible patients were those with high-risk non-muscle-invasive BC, failing 1 course of BCG therapy. All patients were randomly allocated to Group A, receiving intravesical gemcitabine (at a dose of 2000 mg/50 mL) twice weekly for 6 consecutive weeks and then weekly for 3 consecutive weeks at 3, 6, and 12 months, or Group B, receiving intravesical BCG (Connaught strain, 81 mg/50 mL) over a 6-week induction course and each week for 3 weeks at 3, 6, and 12 months. Outcome measures were recurrence rate, time to first recurrence, and progression rate. Treatment-related complications were also evaluated. RESULTS: Eighty participants were enrolled, 40 for each group 52.5% in Group A developed disease recurrence versus 87.5% of those in Group B (P = .002). There was no statistically significant difference in mean time to the first recurrence (Group A, 3.9 months; Group B, 3.1 months; P = .09). Kaplan-Meier analysis of 2-year recurrence-free survival showed significant differences between Group A and B (19% and 3%, respectively, P < .008). Seven of 21 (33%) patients in Group A and 13 of 35 (37.5%) patients in Group B had disease progression and underwent radical cystectomy (P = .12). Both intravesical administrations were generally well tolerated. CONCLUSIONS: Gemcitabine might represent a second-line treatment option after BCG failure in high-risk non-muscle-invasive BC patients. Cancer 2010. © 2010 American Cancer Society.

BACKGROUND: Prostate cancer antigen 3 (PCA3) holds promise in diagnosing prostate cancer (PCa), but no consensus has been reached on its clinical use. Multivariable predictive models have shown increased accuracy over individual risk factors. OBJECTIVE: To compare the performance of the two available risk estimators incorporating PCA3 in the detection of PCa in the "grey area" of prostate-specific antigen (PSA) 10 ng/ml) and/or abnormal digital rectal examination were prospectively enrolled in a multicentre Italian study between October 2008 and October 2009. All patients underwent ≥12-core prostate biopsy. MEASUREMENTS: PCA3 scores were assessed using the Progensa assay (Gen-Probe, San Diego, CA, USA). Comparisons between the two models were performed using tests of accuracy (area under the receiver operating characteristic curve [AUC-ROC]), calibration plots, and decision curve analysis. Biopsy predictors were identified by univariable and multivariable logistic regression. In addition, performance of PCA3 was analysed through AUC-ROC and predictive values. RESULTS AND LIMITATIONS: PCa was detected in 73 patients (33.5%). Among predictors included in the models, only PCA3, PSA, and prostate volume retained significant predictive value. AUC-ROC was higher for the updated PCPT calculator compared to Chun's nomogram (79.6% vs 71.5%; p=0.043); however, Chun's nomogram displayed better overall calibration and a higher net benefit on decision curve analysis. Using a probability threshold of 25%, no high-grade cancers would be missed; the PCPT calculator would save 11% of biopsies, missing no cancer, whereas Chun's nomogram would save 22% of avoidable biopsies, although missing 4.1% non-high-grade cancers. The small number of patients may account for the lack of statistical significance in the predictive value of individual variables or model comparison. CONCLUSIONS: Both Chun's nomogram and the PCPT calculator, by incorporating PCA3, can assist in the decision to biopsy by assignment of an individual risk of PCa, specifically in the PSA levels

Purpose No previous prospective trials have been reported with sorafenib in patients with sunitinib-refractory metastatic renal cell cancer (MRCC). We conducted a multicenter study to determine the activity and tolerability of sorafenib as second-line therapy after sunitinib progression in MRCC. Patients and Methods Between January 2006 and September 2008, 52 patients were enrolled onto this single-arm phase II study. All patients received sorafenib 400 mg orally twice a day until disease progression or intolerable toxicity. The primary end point was objective response rate (complete or partial response) evaluated every 8 weeks by use of the Response Evaluation Criteria in Solid Tumors; secondary end points were toxicity, time to progression (TTP), and overall survival (OS). Results All patients were included in response and safety analyses. Partial responses were observed in 9.6% of patients (five of 52 patients; 95% CI, 5% to 17%) after two cycles. Grade 1 to 2 fatigue, diarrhea, nausea/vomiting, rash, and neutropenia were the most common side effects, noted in 16 (30.8%), 19 (36.5%), 20 (38.5%), 19 (36.5%), and 20 patients (38.5%), respectively. The most common grade 3 toxicity was diarrhea, noted in six patients (11.5%). Median TTP was 16 weeks (range, 8 to 40 weeks), and median OS was 32 weeks (range, 16 to 64 weeks). Conclusion Although well tolerated, sorafenib shows limited efficacy in sunitinib-refractory MRCC. Further randomized trials comparing sorafenib with other drugs that target different biologic pathways are needed to define the best second-line treatment option in these patients.

Aims: To compare health related quality of life (HRQOL) between patients with two different types of urinary diversion, ileal conduit and orthotopic neobladder, and between them and an age-matched population of healthy subjects. Materials and methods: Eighty eight patients treated with radical cystectomy for bladder cancer at our institutions between 2002 and 2007 were contacted for this survey. All of them had a follow-up of more than 12 months after surgery and were recurrence free. The SF-36 questionnaire was provided to each patient during a follow-up visit at outpatient clinics. Overall, 79 patients (90%) returned the questionnaire and were included in this analysis. They were divided into two groups: group 1 comprised 44 patients with an ileal conduit diversion, and group 2 included 35 patients with a neobladder. As a control, normative values of an age-matched healthy Italian population were considered. Results: No significant difference was found in scale scores between the neobladder and ileal conduit groups. Scale scores for role-physical functioning, social functioning and role-emotional functioning in both the neobladder and ileal conduit groups were significantly below the Italian population norm. Patients with a neobladder 65 years old or older (n = 18) had significantly lower scores for role-physical functioning and role-emotional functioning than those younger than 65 years (n = 17; p < 0.05). Conclusion: Few differences between ileal conduit and orthotopic bladder substitution have been detected. Thus, the assumption that continent reconstruction provides better HRQOL than ileal conduit diversion cannot be supported. Patient education and active participation in treatment decisions seem to be the key to postoperative satisfaction. © 2008 Elsevier Ltd. All rights reserved.

Background No data have been published on the midterm efficacy of bipolar transurethral resection of the prostate (TURP). Objective To evaluate 4-yr results from a prospective randomised trial comparing bipolar TURP with standard monopolar TURP. Design, setting, and participants Seventy patients with symptomatic benign prostatic hyperplasia were enrolled in this prospective randomised controlled trial in a tertiary-care institution. Inclusion criteria were age >50 yr, good performance status, urinary retention, International Prostate Symptom Score (IPSS) ≥18, and maximal flow rate (Q max ) ≤15ml/s. Exclusion criteria were prostate volume 3 , documented or suspected prostate cancer, neurogenic bladder, bladder stone or diverticula, urethral stricture, and maximal bladder capacity >500ml. Intervention Patients underwent standard or bipolar plasmakinetic TURP performed by the same surgeon using the same surgical technique. Measurements Treatment efficacy was evaluated at 1, 2, 3, and 4 yr by comparing urinary flow rates, IPSS, and estimated postvoid residual (PVR) urine volume. Midterm complications were also recorded. Results and limitations The number of dropouts was not statistically significantly different in the two groups ( p =0.2). The significant improvements in both groups were maintained at 4 yr for the IPSS, quality of life score, Q max , and PVR versus baseline values. The main outcome variables at 4 yr for bipolar and monopolar TURP were mean IPSS 6.9 and 6.4 ( p =0.58); mean Q max 19.8ml/s and 21.2ml/s ( p =0.44), and mean PVR volume 42ml and 45ml ( p =0.3). Overall, 2 of 32 (6.2%) and 3 of 31 (9.6%) patients required reoperation because of late complications ( p =0.15). The major study limitation was the small sample size. Conclusions This study represents the secondary, midterm analysis of a previously published trial. Our 4-yr data confirm our initial positive findings for the efficacy and safety of bipolar plasmakinetic TURP. Larger well-designed studies are needed to corroborate these findings.

The aim of this study was to evaluate the impact of symptoms of overactive bladder syndrome (OAB) on the quality of life (QoL) in female patients with or without multiple sclerosis (MS) and their correlation with findings from urodynamics (UDS). We enrolled 107 female patients with clinically definite MS and urinary symptoms of OAB. One-hundred female patients with similar OAB symptoms were used as a control group. Data on OAB symptoms, onset and progression, and results of any previous investigation were obtained, and any urinary complications were documented. A complete UDS investigation was performed. Health status assessment was obtained using the Kings Health Questionnaire. Results showed that urinary symptoms had a greater impact on the QoL in patients with MS. Nevertheless, the perception of the severity of these symptoms was minor in the MS group compared to the control group. No significant correlations were found between the dysfunctions as detected by UDS and the OAB symptoms in both groups. Recurrent urinary tract infections represented the main complication in the study population. In conclusion, OAB symptoms have a major impact on the QoL in patients with MS, even if their perception of QoL impairment remains limited. Optimal management in these subjects should include a complete UDS assessment.

Background and Objectives We report our initial experience with a relatively new technique, the so-called “dynamic sentinel node biopsy”, in patients with penile cancer. Methods From January 2001 to February 2003, 17 consecutive patients with bilateral, clinically node negative penile cancer were enrolled. Dynamic sentinel node biopsy was followed by local excision of the primary lesion or penile amputation during the same session. Standard inguinal node dissection was performed 4 weeks after the first operation in all the patients. Results Pre-operative lymphoscintigraphy revealed no sentinel nodes in 1, unilateral sentinel nodes in 5, and bilateral in 11 patients. Metastases were noted in 5 out of 16 patients (31.25%), bilaterally in 3 of them. Among the five patients with sentinel node metastasis, this was the only tumor positive lymph node in one patient. In all cases with negative dynamic sentinel node biopsy, no metastatic nodes were found at the following inguinal node dissection. Therefore, the technique showed a 100% negative predictive value and an 88% sensitivity. Conclusions We believe that dynamic sentinel node biopsy is a minimally invasive procedure that can be easily performed. The goal is to offer the possibility of less extensive surgery for selected low risk patients. J. Surg. Oncol. 2006;93: 181–185. © 2006 Wiley-Liss, Inc.

Objectives To compare bipolar plasmakinetic (PK) with standard monopolar transurethral resection of the prostate (TURP). Methods A total of 70 patients were prospectively randomized into two groups: 35 patients underwent PK TURP with the Gyrus device, and 35 patients underwent standard monopolar TURP. We evaluated the time to catheter removal and hospital discharge, operating time, blood loss, postoperative irrigation, complications, urinary flow rates, symptom relief, and postvoid residual volumes. Results At baseline, the study groups were comparable in age, prostate volume, mean prostate-specific antigen value, International Prostate Symptom Score, quality-of-life score, flow rate, and postvoid residual volume. The mean catheterization time was 72 and 100 hours in the PK and standard groups, respectively. This difference was statistically significant (P

Objective: To evaluate the effect of stent diameter on patients' symptoms and quality of life (QoL) by using dedicated questionnaires. Methods: We prospectively enrolled 34 patients with unilateral ureteral obstruction due to urinary stone undergoing to ureteral stenting (17 pts with 4.8 F and 17 pts with 6 F) before treatment of stone disease. Twenty-one patients with lower urinary symptoms from other causes were used as a control group. Two questionnaires, one on QoL and another on stent specific symptoms, were administered to patients one week after stent positioning and 4 week after removal. Results: There was a significant association between stent state and answers on pain and discomfort on QoL questionnaire. A high percentage of patients reported anxiety and depression associated with the stent. Similar significant association was found between stent state and urinary symptoms and pain. No differences in QoL and urinary symptoms and pain were detected using stents with different size. Conclusions: Ureteral stents are invariably associated with urinary symptoms and impaired QoL. We did not find any difference between stent with different size, whereas there was a tendency for stent with smaller diameter to dislodge more often.

During the last decade the development of prostate biopsy has continuously accelerated. Much has been written about the indications for biopsy, patient preparation, the potential complications associated with the procedure, and the optimum number of biopsy cores. However, minor emphasis has been placed on the problem of reducing pain during the procedure, as patient discomfort has usually been considered as a necessary part of it

Purpose: We investigated the role of tamoxifen. and radiotherapy (RT) for the prevention and treatment of gynecomastia and breast pain during adjuvant bicalutamide monotherapy after radical prostatectomy (RP) in patients with prostate cancer. Also, we evaluated their effects on patient hormonal status, quality of life (QOL), sexual function and prostate specific antigen relapse-free survival. Materials and Methods: This was a multicenter prospective trial. From January 2002 to February 2004, 102 patients who had undergone RP for localized or locally advanced prostate cancer were recruited and randomized into 3 groups, namely group 1-those receiving only 150 mg bicalutamide as adjuvant hormonal therapy, group 2-those receiving bicalutamide and 10 mg tamoxifen, and group 3-those receiving bicalutamide and RT. Patients in group 1 in whom gynecomastia or breast pain developed were subsequently randomized to receive tamoxifen or RT soon after symptoms started. Gynecomastia, breast pain, prostate specific antigen, QOL, sexual function and hormonal levels were assessed. Minimum followup was 12 months. Results: Of group 1 patients 67% had gynecomastia compared with 8% in group 2 and 34% in group 3. Breast pain was more frequent in group 1 than in groups 2 and 3 (58% vs 7% and 30%, respectively). Differences were significant between groups 1 and 2 (OR 0.12 p

Objective To identify criteria with which to select candidates for conservative nephrectomy, and to compare the results of radical and conservative nephrectomy in two homogeneous groups of patients with renal carcinoma, in a prospective study. Patients and methods Forty patients (27 men and 13 women, mean age 49.9 years, range 23–76) with renal carcinoma (T1-T2 N0M0