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Background: Previous prospective randomised trials have shown a positive impact of adjuvant radiation therapy (RT) in patients with locally advanced prostate cancer. However, none of these trials included patients with lymph node invasion (LNI). Objective: The aim of this study was to assess the impact of combination adjuvant hormonal therapy (HT) and RT on the survival of patients with prostate cancer and histologically documented lymph node metastases (pN+). Design, setting, and participants: Data on 703 consecutive patients with LNI treated with radical prostatectomy, pelvic lymph node dissection, and adjuvant treatments between September 1986 and November 2002 at two large academic institutions were reviewed. Measurements: For study purposes, patients treated with adjuvant HT plus RT and patients treated with adjuvant HT alone were matched for age at surgery, pathologic T stage and Gleason score, number of nodes removed, surgical margin status, and length of follow-up. Differences in cancer-specific survival (CSS) and overall survival (OS) were compared using the Kaplan-Meier method and life table analyses. Results and limitations: Following the matching process, 117 pT2-4 pN1 patients of 171 (68.4%) treated with adjuvant HT plus RT (group 1) were compared with 247 pT2-4 pN1 patients of 532 (46.4%) receiving adjuvant HT alone (group 2). After matching, the two groups of patients were comparable in terms of pre- and postoperative characteristics (all p >= 0.07). Mean follow-up was 100.8 mo (median: 95.1 mo; range: 3.5-229.3 mo). Overall, prostate CSS and OS rates at 5, 8, and 10 yr were 90%, 82%, and 75%, and 85%, 70%, and 60%, respectively. Patients treated with adjuvant RT plus HT had significantly higher CSS and OS rates compared with patients treated with HT alone at 5, 8, and 10 yr after surgery (95%, 91%, and 86% vs 88%, 78%, and 70%, and 90%, 84%, and 74% vs 82%, 65%, and 55%, respectively; p = 0.004 and p < 0.001, respectively). Similarly, higher survival rates associated with the combination of HT plus RT were found when patients were stratified according to the extent of nodal invasion (namely, two or fewer vs more than two positive nodes; all p = 0.07). Mean follow-up was 100.8 mo (median: 95.1 mo; range: 3.5-229.3 mo). Overall, prostate CSS and OS rates at 5, 8, and 10 yr were 90%, 82%, and 75%, and 85%, 70%, and 60%, respectively. Patients treated with adjuvant RT plus HT had significantly higher CSS and OS rates compared with patients treated with HT alone at 5, 8, and 10 yr after surgery (95%, 91%, and 86% vs 88%, 78%, and 70%, and 90%, 84%, and 74% vs 82%, 65%, and 55%, respectively; p = 0.004 and p < 0.001, respectively). Similarly, higher survival rates associated with the combination of HT plus RT were found when patients were stratified according to the extent of nodal invasion (namely, two or fewer vs more than two positive nodes; all p

Purpose: To report on planning and toxicity findings of hypofractionated adjuvant radiotherapy with helical Tomotherapy (HTT) after radical prostatectomy (RP) for prostate carcinoma (pCa). Methods and materials: Fifty consecutive patients submitted to RP for pT2R1/pT3a/pT3b-pN0 pCa were enrolled in a Phase I-II trial to receive 58 Gy/20 fractions (5/week) on tumoral bed. Endpoint was to verify a risk of toxicity and biochemical failure not exceeding that observed in our Institutional 3DCRT, conventionally fractionated series (15 3 patients). Toxicities were graded according the RTOG scoring system. Results: Excellent coverage of PTV and high homogeneity of dose distribution were always achieved. Median follow-up was 25 months. Acute G2-3 RTOG genitourinary (GU) and acute G2 intestinal toxicities were similar (12% vs 15.6% and 4% vs 7%, respectively), while acute G2 proctitis was 0% vs 9% in HTT and 3DCRT group, respectively. Similarly, late Grade >= 2 gastrointestinal sequelae were 0% vs 8.5%. The incidence of late urethral stricture, 8% and 9% in HTT and 3DCRT group, respectively, is comparable to that of RP-only series. Conclusions: Acute toxicity and early late toxicity outcomes of a moderately hypofractionated regimen with HTT post-RP are excellent. A longer follow-up is needed to fully assess the validity of this approach. (c) 2008 Elsevier Ireland Ltd. All rights reserved. Purpose: To report on planning and toxicity findings of hypofractionated adjuvant radiotherapy with helical Tomotherapy (HTT) after radical prostatectomy (RP) for prostate carcinoma (pCa). Methods and materials: Fifty consecutive patients submitted to RP for pT2R1/pT3a/pT3b-pN0 pCa were enrolled in a Phase I-II trial to receive 58 Gy/20 fractions (5/week) on tumoral bed. Endpoint was to verify a risk of toxicity and biochemical failure not exceeding that observed in our Institutional 3DCRT, conventionally fractionated series (15 3 patients). Toxicities were graded according the RTOG scoring system. Results: Excellent coverage of PTV and high homogeneity of dose distribution were always achieved. Median follow-up was 25 months. Acute G2-3 RTOG genitourinary (GU) and acute G2 intestinal toxicities were similar (12% vs 15.6% and 4% vs 7%, respectively), while acute G2 proctitis was 0% vs 9% in HTT and 3DCRT group, respectively. Similarly, late Grade >= 2 gastrointestinal sequelae were 0% vs 8.5%. The incidence of late urethral stricture, 8% and 9% in HTT and 3DCRT group, respectively, is comparable to that of RP-only series. Conclusions: Acute toxicity and early late toxicity outcomes of a moderately hypofractionated regimen with HTT post-RP are excellent. A longer follow-up is needed to fully assess the validity of this approach. (c) 2008 Elsevier Ireland Ltd. All rights reserved.

Objective: To evaluate the effect of BXL628, a vitamin D3 analog, on prostate volume in patients with benign prostatic hyperplasia (BPH). Methods: We conducted a phase II, double blind, randomized, placebo controlled, clinical study. Patients eligible were aged >= 50 years, had a diagnosis of BPH and a prostate volume >= 40 ml. Eligible patients were randomized and given either BXL628 150 mcg daily or placebo for 12 weeks. All randomized patients underwent at baseline and at the end of study pelvic MRI to measure prostatic volume, uroflowmetry (Q(max)), American Urological Association Symptom Index (AUASI), serum PSA, testosterone, dihydrotestosterone and luteizing hormone. Results: A total of 119 patients were randomized: 57 patients to BXL628 and 62 to placebo. The percentage change of prostate volume at 12 week was -2.90 in the BXL628 group vs. +4.32 in the placebo group (p-value < 0.0001). The estimated difference between treatments (BXL628 minus placebo) was -7.22% (95% confidence limit -9.27 to -5.18). Considering Q(max), mean change vs. baseline was -0.30 in BXL628 vs. +1.50 in the placebo group: this finding was not statistically significant. The mean change of the AUASI total score at final visit vs. baseline was -1.77 in the BXL628 group vs. -3.45 in the placebo group (p = not significant). Conclusion: BXL628 was able to arrest prostate growth within 12 weeks in men aged >= 50 years with prostatic volume >= 40 ml. Its unprecedented mechanism of action may offer a new opportunity for the treatment of BPH. (c) 2005 Elsevier B.V. All rights reserved.

Objective To test whether the combination of number and location of distant metastases affects cancer-specific survival in patients with metastatic renal cell carcinoma. Methods Overall, 242 metastatic renal cell carcinoma patients with synchronous metastases at diagnosis underwent cytoreductive nephrectomy at a single institution. Combinations of number and location of distant metastases were coded as: single metastasis and single organ affected, multiple metastases and single organ affected, single metastasis for each of the multiple organs affected, and multiple metastases for each of the multiple organs affected. Covariates included age, symptoms, performance status, American Society of Anesthesiologists score, hemoglobin, lactate dehydrogenase, tumor size, Fuhrman grade, T stage, lymph node status, necrosis, sarcomatoid features and metastasectomy at the time of nephrectomy. Results The median survival was 34.7 versus 32.3 versus 29.6 versus 8.5months for single metastasis and single organ affected, multiple metastases and single organ affected single metastasis for each of the multiple organs affected, and multiple metastases for each of the multiple organs affected patients, respectively. At multivariable analyses, the combination of number and location of distant metastases resulted in one of the most informative and independent predictors of cancer-specific survival in metastatic renal cell carcinoma patients. The lung was the location with the highest rate of single organ affected (50.3% vs 35.1% in other sites; P

What's known on the subject? and What does the study add? Urinary incontinence is one of the most important morbidities after radical prostatectomy that has detrimental effect on the postoperative quality of life. The present study provides an accurate and dynamic multivariable risk stratification tool that predicts the postoperative urinary incontinence risk after radical prostatectomy based on patient-related as well as surgeon-related variables. Objective To develop a multivariable risk classification tool to estimate postoperative urinary incontinence (UI) risk as UI represents one of the most disabling surgical sequelae after radical prostatectomy (RP). Patients and Methods We evaluated 1311 patients treated with nerve-sparing RP between 2006 and 2010 at our institution. Regression tree analysis was used to stratify patients according to their postoperative UI risk. KaplanMeier curve estimates were used to assess the UI rate in the novel UI-risk groups. The discrimination of the novel tool was measured with the area under the curve method. Results At 3, 6 and 12 months, the UI rates were 44%, 26% and 12%, respectively. Regression tree analysis stratified patients into high risk (International Index of Erectile Function Erectile Function domain [IIEF-EF] = 110), intermediate risk (IIEF-EF > 10 and age 65 years), low risk (IIEF-EF > 10, age < 65 years and body mass index [BMI] 25kg/m2) and very low risk (IIEF-EF > 10, age < 65 years and BMI < 25kg/m2) groups. The 3-month UI rates in these groups were 37%, 43%, 45% and 48%, respectively. The 6-month UI rates were 19%, 23%, 29% and 34%, respectively. The 12-month UI rates were 7%, 13%, 14% and 15%, respectively (log-rank P < 0.001). The area under the curve was 71%, 70% and 68% at 3, 6 and 12 months, respectively. Conclusions We developed the first risk classification tool that predicts patients at high risk of UI after RP. These consisted mainly of individuals who were impotent before RP, elderly and/or overweight. This tool can be used for patient counselling.

What's known on the subject? and What does the study add? Previous studies have retrospectively compared functional and oncological outcomes between robot-assisted radical prostatectomy (RARP) and open retropubic radical prostatectomy (RRP), reporting non-inferior or superior outcomes associated with the use of the robotic approach. The study demonstrates that baseline selection biases makes comparisons of RARP and RRP problematic. Patients treated with RARP may have significantly better baseline characteristics than patients treated with RRP. Indeed, when both facilities are available within the same centre, patients with the most favourable clinical and cancer profile are inherently selected to RARP. In the absence of a prospective randomized trial, the decision to prefer one approach over another should be tailored according to each single patient and surgeon. Objective To evaluate the trend in robot-assisted radical prostatectomy (RARP) and open retropubic radical prostatectomy (RRP) use over time and to compare preoperative and pathological characteristics of patients treated with RARP or RRP at a single centre. Patients and Methods Between 2006 and 2010, 2511 consecutive patients treated with RP, with or without pelvic lymph node dissection (PLND), for prostate cancer (PCa) at a single tertiary care centre were analysed. Baseline patient characteristics and PCa risk distribution were compared according to treatment type (RRP vs RARP) in the overall population, as well as in three surgeons' initial 50 RARP and three surgeons' initial 50 RRP cases (n = 300). We used a chi-squared trend test to evaluate the differences in treatment type administration over time according to PCa characteristics. Logistic regression analyses focused on the prediction of PLND and adjuvant radiotherapy (RT) use. Results Overall, 1873 (74.6%) and 638 (25.4%) patients underwent RRP and RARP, respectively. Men treated with RARP were younger (mean age: 62 vs 65 years), less obese (mean BMI: 24.8 vs 26.4kg/m2), healthier (Charlson comorbidity index = 0: 68.7 vs 53.3%) and more likely to harbour clinical low-risk PCa (51 vs 30%) than their RRP counterparts (all P < 0.001). Similar findings were observed in sub-analyses focusing on six surgeons' 50 initial patients (all P 0.02). A significant increase in the rate of patients with low-risk PCa treated with RARP vs RRP was reported over time (5 vs 95% and 66 vs 34% in 2006 and 2010, respectively). Conversely, 76% of patients with high risk PCa were still treated with RRP in 2010. Patients treated with RARP were less likely to receive PLND at RP and adjuvant RT (all P 0.01), even after adjusting for clinical and PCa characteristics. Conclusions The introduction of a robotic training programme at a high volume centre led to significant patient selection in terms of clinical and PCa characteristics. When both RRP and RARP facilities are available within the same centre, patients with the most favourable clinical and cancer profile are selected to undergo RARP. Use of RARP negatively influenced the rates and the extent of PLND as well as the use of adjuvant RT after surgery. Thus, baseline patient selection, surgical and treatment biases make any comparisons of RARP with RRP problematic.

Background: The role of adjuvant radiotherapy (ART) after radical prostatectomy (RP) on survival of patients with prostate cancer (PCa) is still controversial. Objective: We tested the impact of ART on cancer-specific mortality (CSM) and overall mortality (OM) in PCa patients according to pathologic PCa features. Design, setting, and participants: We evaluated 1049 PCa patients treated with RP and extended pelvic lymph node dissection alone or in combination with adjuvant treatments between 1998 and 2008. All patients had positive surgical margins and/or pT3/pT4 disease with or without positive lymph nodes. Outcome measurements and statistical analysis: Cox regression analyses tested the relationship between pathologic characteristics and CSM rates. Independent predictors of survival were used to develop a novel risk score based on the number of risk factors. Finally, Cox regression models tested the relationship between ART and survival according to the number of risk factors. Results and limitations: On multivariable analyses, only pathologic Gleason score >= 8, pT3b/T4 stage, and presence of positive lymph nodes represented independent predictors of CSM (all p = 0.4). Conversely, in patients with a risk score >= 2, ART was associated with lower CSM and OM rates (all p = 0.006). The observational nature of the cohort represents a limitation of the study. Conclusions: ART significantly improved survival only in patients with at least two of the following pathologic features at RP: Gleason score >= 8, pT3/pT4 disease, and positive lymph nodes. These patients represent the ideal candidates for ART after RP. (c) 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.

11C-CHOLINE-POSITRON EMISSION TOMOGRAPHY/COMPUTERISED TOMOGRAPHY FOR PREOPERATIVE LYMPHNODE STAGING IN INTERMEDIATE-RISK AND HIGH-RISK PROSTATE CANCER: COMPARISON WITH CLINICAL STAGING NOMOGRAMS

Objectives: To compare the efficacy of bicalutamide monotherapy to maximal androgen blockade in advanced prostatic cancer. Patients and Methods: Previously untreated patients with histologically proven stage C or D (American Urological Association Staging System) disease were randomly allocated to either bicalutamide (B) or goserelin plus flutamide (G+F). After disease progression, patients treated with B were assigned to castration. The primary endpoint for this trial was overall survival. Prostate cancer-specific survival and progression were included among secondary endpoints. Results: In total 108 patients received B and 112 received G+F. At a median follow-up time of 54 months (range 1–89), 151 patients progressed and 113 died. There was no significant difference in the duration of either progression-free or overall survival. Hazards of progression, death and cancer-specific death, corrected by disease stage, tumor grade and baseline PSA level, showed that patients initially assigned to B had a higher risk of progression but a comparable risk of death and cancer-specific death with the exception of patients with G3 tumors who had an increased risk of death). Conclusions: In patients with well or moderately well differentiated tumors, B monotherapy followed by castration may offer the same survival chance as maximal androgen deprivation. In those patients it thus represents a reasonable choice that can avoid the side effects of androgen deprivation for considerable periods of time.

Background: Conventional imaging (CI) techniques are inadequate for lymph node (LN) staging in prostate cancer (PCa). Objectives: To assess the accuracy of C-11-Choline positron emission tomography/computerized tomography (PET/CT) for LN staging in intermediate-risk and high-risk PCa and to compare it with two currently used nomograms. Design, Setting, and Participants: From January 2007 to September 2007, 57 PCa patients at intermediate risk (n = 27) or high risk (n = 30) were enrolled at two academic centres. All patients underwent preoperative PET/CT and radical prostatectomy with extended pelvic LN dissection (PLND). Risk of LN metastasis (LNM) was assessed using available nomograms. Measurements: Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and number of correctly recognized cases for LNM detection at PET/CT were assessed. The accuracy of PET/CT for LNM detection was compared with the accuracy of nomograms for LNM prediction by using receiver operating characteristic (ROC) analysis. Results and Limitations: Fifteen patients (26%) had LNMs, and a total of 41 LNMs were identified. on a patient analysis, sensitivity, specificity, PPV, NPV, and number of correctly recognized cases at PET/CT were 60.0%, 97.6%,90.0%, 87.2%, and 87.7% while, on node analysis, these numbers were 41.4%, 99.8%, 94.4%, 97.2%, and 97.1%. The mean diameter (in mm) of the metastatic deposit of true-positive LNs was significantly higher than that of false-negative LNs (9.2 vs 4.2; p = 0.001). PET/CT showed higher specificity and accuracy than the nomograms; however, in pairwise comparison, the areas under the curve (AUCs) were not statistically different (all p values >0.05). Conclusions: In patients with intermediate-risk and high-risk PCa, C-11-Choline PET/CT has quite a low sensitivity for LNM detection but performed better than clinical nomograms, with equal sensitivity and better specificity. (C) 2008 European Association of Urology. Published by Elsevier B.V. All rights reserved. Background: Conventional imaging (CI) techniques are inadequate for lymph node (LN) staging in prostate cancer (PCa). Objectives: To assess the accuracy of C-11-Choline positron emission tomography/computerized tomography (PET/CT) for LN staging in intermediate-risk and high-risk PCa and to compare it with two currently used nomograms. Design, Setting, and Participants: From January 2007 to September 2007, 57 PCa patients at intermediate risk (n = 27) or high risk (n = 30) were enrolled at two academic centres. All patients underwent preoperative PET/CT and radical prostatectomy with extended pelvic LN dissection (PLND). Risk of LN metastasis (LNM) was assessed using available nomograms. Measurements: Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and number of correctly recognized cases for LNM detection at PET/CT were assessed. The accuracy of PET/CT for LNM detection was compared with the accuracy of nomograms for LNM prediction by using receiver operating characteristic (ROC) analysis. Results and Limitations: Fifteen patients (26%) had LNMs, and a total of 41 LNMs were identified. on a patient analysis, sensitivity, specificity, PPV, NPV, and number of correctly recognized cases at PET/CT were 60.0%, 97.6%,90.0%, 87.2%, and 87.7% while, on node analysis, these numbers were 41.4%, 99.8%, 94.4%, 97.2%, and 97.1%. The mean diameter (in mm) of the metastatic deposit of true-positive LNs was significantly higher than that of false-negative LNs (9.2 vs 4.2; p = 0.001). PET/CT showed higher specificity and accuracy than the nomograms; however, in pairwise comparison, the areas under the curve (AUCs) were not statistically different (all p values >0.05). Conclusions: In patients with intermediate-risk and high-risk PCa, C-11-Choline PET/CT has quite a low sensitivity for LNM detection but performed better than clinical nomograms, with equal sensitivity and better specificity. (C) 2008 European Association of Urology. Published by Elsevier B.V. All rights reserved.

The clinical effects of a new self-injection pen were investigated in 160 impotent patients undergoing intracavernous vasoactive pharmacotherapy. Of the patients previously using insulin syringes for self-injection 90% switched to the pen, since it was considered easier to use and several injections could be performed with the same drug cartridge, thus avoiding the preparation necessary before every single injection with the syringe. Dropout rates were 36% and 12% for patients using the syringe and the pen, respectively (p

Background: Recent large, prospective, randomised studies have demonstrated that adjuvant radiotherapy (RT) is a safe and effective procedure for preventing disease recurrence in locally advanced prostate cancer (PCa) patients. However, no study has ever tested the role of adjuvant RT in node-positive patients after radical prostatectomy (RP). Objective: We hypothesised that adjuvant RT with early hormone therapy (HT) might improve long-term outcomes of patients with PCa and nodal metastases treated with RP and extended pelvic lymph node dissection (ePLND). Design, setting, and participants: This retrospective study included 250 consecutive patients with pathologic lymph node invasion. We assessed factors predicting long-term biochemical recurrence (BCR)-free and cancer-specific survival (CSS) in node-positive PCa patients treated with RP, ePLND, and adjuvant treatments between 1988 and 2002 in a tertiary academic centre. Intervention: All patients received adjuvant treatments according to the treating physician after detailed patient information: 129 patients (51.6%) were treated with a combination of RT and HT, while 121 patients (48.4%) received adjuvant HT alone. Measurements: BCR-free survival and CSS in patients with node-positive PCa. Results and limitations: mean follow-up was 95.9 mo (median: 91.2). BCR-free survival and CSS rates at 5, 8, and 10 yr were 72%, 61%, 53% and 89%, 83%, 80%, respectively. In multivariable Cox regression models, adjuvant RT and the number of positive nodes were independent predictors of BCR-free survival (p = 0.002 and p = 0.003, respectively) as well as of CSS (p = 0.009 and p = 0.01, respectively). Moreover, there was significant gain in predictive accuracy when adjuvant RT was included in multivariable models predicting BCR-free survival and CSS (gain: 3.3% and 3%, respectively; all p < 0.001). Conclusions: Our data showed excellent long-term outcome for node-positive PCa patients treated with radical surgery plus adjuvant treatments. This study is the first to report a significant protective role for adjuvant RT in BCR-free survival and CSS of node-positive patients. (C) 2009 European Association of Urology. Published by Elsevier B.V. All rights reserved. Background: Recent large, prospective, randomised studies have demonstrated that adjuvant radiotherapy (RT) is a safe and effective procedure for preventing disease recurrence in locally advanced prostate cancer (PCa) patients. However, no study has ever tested the role of adjuvant RT in node-positive patients after radical prostatectomy (RP). Objective: We hypothesised that adjuvant RT with early hormone therapy (HT) might improve long-term outcomes of patients with PCa and nodal metastases treated with RP and extended pelvic lymph node dissection (ePLND). Design, setting, and participants: This retrospective study included 250 consecutive patients with pathologic lymph node invasion. We assessed factors predicting long-term biochemical recurrence (BCR)-free and cancer-specific survival (CSS) in node-positive PCa patients treated with RP, ePLND, and adjuvant treatments between 1988 and 2002 in a tertiary academic centre. Intervention: All patients received adjuvant treatments according to the treating physician after detailed patient information: 129 patients (51.6%) were treated with a combination of RT and HT, while 121 patients (48.4%) received adjuvant HT alone. Measurements: BCR-free survival and CSS in patients with node-positive PCa. Results and limitations: mean follow-up was 95.9 mo (median: 91.2). BCR-free survival and CSS rates at 5, 8, and 10 yr were 72%, 61%, 53% and 89%, 83%, 80%, respectively. In multivariable Cox regression models, adjuvant RT and the number of positive nodes were independent predictors of BCR-free survival (p = 0.002 and p = 0.003, respectively) as well as of CSS (p = 0.009 and p = 0.01, respectively). Moreover, there was significant gain in predictive accuracy when adjuvant RT was included in multivariable models predicting BCR-free survival and CSS (gain: 3.3% and 3%, respectively; all p < 0.001). Conclusions: Our data showed excellent long-term outcome for node-positive PCa patients treated with radical surgery plus adjuvant treatments. This study is the first to report a significant protective role for adjuvant RT in BCR-free survival and CSS of node-positive patients. (C) 2009 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Twenty high risk patients with benign prostatic hyperplasia and urinary retention were treated by insertion of an intraprostatic spiral. The device was positioned under fluoroscopic guidance using a technique developed by us. The procedure required only local anaesthesia and successfully relieved the obstruction in all patients. At the six-month follow-up full continence had been achieved in 15 patients (75%). Three patients (15%) complained of mild stress incontinence but this was not severe enough to require removal and repositioning of the spiral. A 92-year-old patient reported severe incontinence despite correct positioning of the spiral. Removal of the spiral was necessary in one of the continent patients who was receiving anti-coagulant drugs because of sudden, severe macrohaematuria with subsequent acute urinary retention. The spiral became displaced and required repositioning in one patient. Median residual urine volume was constantly lower than 50 ml and the median maximum flow rate at six-month follow-up was 13.2 ml/s. Our long term follow-up study shows the effectiveness and safety of the prostatic spiral as an alternative treatment for selected patients with urinary retention caused by benign prostatic hyperplasia.

Purpose: According to the 2002 American Joint Committee on Cancer TNM classification, perinephric and renal sinus fat invasion are classified as pT3a renal cell carcinoma. However, only a few studies have assessed the impact of sinus fat invasion on patient survival and with controversial results. We analyzed the impact of sinus fat invasion on cancer specific survival in a cohort of patients with pT3a clear cell renal cell carcinoma. Materials and Methods: We retrospectively analyzed data on 115 consecutive patients treated with open radical nephrectomy for unilateral, sporadic pT3a clear cell renal cell carcinoma at our department from 1989 to 2006. All pathological specimens were rereviewed by a single uropathologist. The prognostic role of sinus fat invasion in cancer specific survival was assessed by Cox proportional hazards regression models. Results: Ten patients had direct ipsilateral adrenal invasion and were excluded from analysis. A total of 105 patients with clear cell renal cell carcinoma were evaluated. Median followup was 38 months. In the overall population sinus fat invasion did not reach independent predictive status in terms of cancer specific survival on multivariate Cox regression analysis after adjusting for age, performance status, tumor dimension, tumor grade, synchronous metastases, nodal involvement, sarcomatoid differentiation and coagulative necrosis. In the subset of patients with pNx/pN0 M0 (83) the actuarial 5-year cancer specific survival was 71.9% and 45.5% for those with perinephric fat invasion only and sinus fat invasion, respectively (p = 0.025). Sinus fat invasion achieved an independent predictive role on multivariable Cox regression analysis (p = 0.048, HR 2.06). Conclusions: Sinus fat invasion in clear cell renal cell carcinoma significantly affects cancer specific survival in patients without nodal or distant metastases. However, sinus fat invasion is not associated with worse cancer specific survival in cases of metastatic disease.

Objectives To analyze the prognostic role of lymphadenectomy (LND) in patients with muscle-invasive transitional cell carcinoma (TCC) of the upper urinary tract (UUT) managed with radical surgery. Methods From 1986 to 2003, 132 consecutive patients with muscle-invasive TCC of the UUT underwent radical surgery. LND was performed in 95 cases. Patients were stratified according to the presence of LND and lymph node (LN) status. Univariable and multivariable Cox regression models determined the effect of age, pT, grade, nodal status (pN), number of LNs removed, year of surgery, and postoperative chemotherapy on disease-free survival (DFS) and cancer-specific survival (CSS) in the overall population and in patients who underwent LND. Results The actuarial 5-yr CSS in pNx patients was significantly worse than in pN0 patients (48% vs. 73%, p = 0.001) and comparable to pN+ outcome (48% vs. 39%, p = 0.476). In the entire population, multivariable Cox regression analyses indicated that pT and pN status were independent predictors of DFS (p = 0.04, hazard ratio [HR] = 1.82 and p < 0.01, HR = 1.34, respectively) and CSS (p < 0.01, HR = 2.42 and p = 0.04, HR = 1.32, respectively). In patients who underwent LND, the number of LNs removed was an independent predictor of DFS (p = 0.03, HR = 0.928) and of CSS (p = 0.007, HR = 0.903). The extent of LND again resulted in an independent predictor either of DFS or CSS (p = 0.04, HR = 0.904 and p = 0.01, HR = 0.867, respectively) in the subgroup of pN0 patients. Conclusions LND emerged as a strong independent predictor of DFS and CSS in patients surgically managed for a muscle-invasive TCC of the UUT.

Background: Previous trials have shown that the number of procedures done by a single surgeon, that is, surgical volume (SV), is associated with several outcomes after radical prostatectomy (RP). Objective: To test the association between SV and the detection of lymph node metastases during extended pelvic lymph node dissection (ePLND). Design, setting, and participants: The study cohort consisted of 1020 men surgically treated for clinically localized prostate cancer. Intervention: All patients underwent RP and ePLND by a group of six surgeons who were trained by the surgeon with the highest SV. All surgeons performed an anatomically extended PLND, including removal of obturator, external iliac, and hypogastric nodes. Measurements: Univariable and multivariable logistic regression models tested the association between SV (either continuously coded or dichotomized according to the most informative cut-off, namely > 144 vs = 0.06). Conversely, the surgeon with the highest SV removed more nodes and found more nodal metastases compared with the other surgeons (21.1 vs 17.9 mean number of nodes removed; p < 0.001, and 15 vs 9.8% of LNI; p = 0.01, respectively). At univariable logistic regression analysis, either continuously coded or dichotomized SV was a significant predictor of LNI (p = 0.007 and p < 0.001, respectively). In multivariable models, continuously coded as well as dichotomized SV maintained a significant association with the rate of LNI, after accounting for preoperative (p = 0.04 and p = 0.009, respectively) as well as for postoperative variables (p = 0.03 and p = 0.002, respectively). Conclusions: After adjusting for clinical and pathologic case-mix differences, patients treated by the highest-volume surgeons (> 144 ePLNDs) were more likely to have LNI than those treated by low-volume surgeons, even though all surgeons used a similar extended template for node removal. (C) 2008 European Association of Urology. Published by Elsevier B.V. All rights reserved. Background: Previous trials have shown that the number of procedures done by a single surgeon, that is, surgical volume (SV), is associated with several outcomes after radical prostatectomy (RP). Objective: To test the association between SV and the detection of lymph node metastases during extended pelvic lymph node dissection (ePLND). Design, setting, and participants: The study cohort consisted of 1020 men surgically treated for clinically localized prostate cancer. Intervention: All patients underwent RP and ePLND by a group of six surgeons who were trained by the surgeon with the highest SV. All surgeons performed an anatomically extended PLND, including removal of obturator, external iliac, and hypogastric nodes. Measurements: Univariable and multivariable logistic regression models tested the association between SV (either continuously coded or dichotomized according to the most informative cut-off, namely > 144 vs = 0.06). Conversely, the surgeon with the highest SV removed more nodes and found more nodal metastases compared with the other surgeons (21.1 vs 17.9 mean number of nodes removed; p < 0.001, and 15 vs 9.8% of LNI; p = 0.01, respectively). At univariable logistic regression analysis, either continuously coded or dichotomized SV was a significant predictor of LNI (p = 0.007 and p < 0.001, respectively). In multivariable models, continuously coded as well as dichotomized SV maintained a significant association with the rate of LNI, after accounting for preoperative (p = 0.04 and p = 0.009, respectively) as well as for postoperative variables (p = 0.03 and p = 0.002, respectively). Conclusions: After adjusting for clinical and pathologic case-mix differences, patients treated by the highest-volume surgeons (> 144 ePLNDs) were more likely to have LNI than those treated by low-volume surgeons, even though all surgeons used a similar extended template for node removal. (C) 2008 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Introduction: The aim of this study is to verify the predictive role of transrectal ultrasound (TRUS) of prostatic fossa, digital rectal examination (DRE), prostate specific antigen (PSA) and pathological stage after radical prostectomy in the detection of a prostate tumor recurrence at the level of the vesico-urethral anastomosis by means of multiple TRUS biopsies (6-8 cores). Material and Methods: From October 1997, following a radical prostatectomy, 119 consecutive patients (median age: 67.9 years) with a PSA greater than or equal to 0.2 ng/ml (median PSA: 0.9 ng/ml) underwent DRE and TRUS examinations with a 5.0-7.5 MHz variable frequency end-fire probe (Hitachi Medical System) and an EUB-525 machine. All patients received six TRUS-guided biopsies of the vesico-urethral anastomosis, and 1-2 additional biopsies directed to hypoechoic or suspicious areas, if detected by TRUS. Results: Biopsies revealed recurrent carcinoma in 50% of patients (60/119). TRUS proved more sensitive than DRE (75% vs. 50%; p = 0.01) and, conversely, DRE proved more specific than a TRUS (85% vs. 66%; P = 0.03). Cancer was detected in 45% of the 34 patients with a PSA less than or equal to 0.5 ng/ml. In the group of patients with a PSA greater than or equal to 2.0 ng/ml (24 patients), TRUS was able to detect every biopsy-proven local recurrence lesion (sensitivity: 100%). Conversely, all patients with a PSA greater than or equal to 2.0 ng/ml and a negative TRUS had a negative biopsy (negative predictive value: 100%). In a multi-variable logistical analysis, the most predictive parameters determining a positive biopsy rate among those values studied (PSA, DRE, TRUS, positive surgical margins, pathological stage and time to PSA elevation) were TRUS and DRE findings (p = 0.003, with an odds ratio of 4.6 and p = 0.02, with an odds ratio of 4.1, respectively). Conclusion: TRUS and TRUS biopsies utilizing 6-8 cores are efficient tools in the detection of local recurrence after a radical prostatectomy, even with a PSA less than or equal to 0.5 ng/ml. A combination of TRUS and DRE findings seems to predict biopsy results best. In case of a PSA greater than or equal to 2.0 ng/ml and a negative TRUS, a biopsy of the vesico-urethral anastomosis could be avoided since the negative predictive value is 100%. Cancer recurrence detection seems to be predicted by TRUS and DRE findings, but not by PSA levels, pathological stage, status of the surgical margins or time to PSA elevation. (C) 2003 Elsevier B.V. All rights reserved.

Purpose: Radical cystectomy is advocated for high risk patients with superficial bladder cancer. To preserve complete urinary continence, normal sexual function and fertility in young patients, we developed an innovative technique based on nerve and seminal sparing radical cystectomy. Materials and Methods: Radical cystectomy was recommended for 8 patients with superficial bladder cancer that was not conservatively manageable. Average patient age was 44 years (range 36 to 48), and all patients were extremely anxious to maintain potency and fertility. The surgical procedure consisted of transurethral resection of the prostate, pelvic iliac lymph node dissection and extraperitoneal radical cystectomy performed while preserving the vas deferens seminal vesicles and neurovascular bundles. Urinary diversion was accomplished with a W-shaped ileal reservoir anastomosed to the prostatic capsule. Results: Patients were generally discharged from the hospital 15 days after surgery, and postoperative morbidity was limited. Daytime and nighttime continence was immediate and complete after catheter removal. Normal erectile function was clinically documented in all patients while fertility potential with semen retrieval via urine was recorded in 7. The quality of life, as reported by the patients, was highly satisfactory at 18-month followup. Conclusions: The surgical approach we describe should be considered in young men with clinical, superficial bladder tumors refractory to conservative treatment who wish to maintain potency and fertility, and to guarantee as good a quality of life as possible. To ensure oncological success scrupulous patient selection is a primary step of this procedure.

Objectives. A nonrandomized prospective study was conducted aimed at verifying the clinical outcome and pathologic features of a group of patients submitted to transcoccygeal radical prostatectomy. Methods. Radical transcoccygeal prostatectomy was performed at our institution in 26 patients after laparoscopic (24 cases) or open surgical (2 cases) pelvic lymphadenectomy. Eighteen patients were selected because they were considered to be at risk for nodal metastases on the basis of preoperative staging (prostate-specific antigen level of 20 ng/mL or greater and/or Gleason score greater than 5); the remaining 8 manifested incidental prostate carcinoma. Results. Intraoperative complications included rectal injury in 1 patient (3.8%) and massive blood loss in another. Transitory leakage at the site of the urethrovesical anastomosis and urethrorectal fistula occurred postoperatively in 2 patients. The rate of positive surgical margins was 26.9%. The mean follow-up time is 27 months (range 3 to 39 months). Total urinary continence was obtained in 21 patients (80.8%); 5 patients (19.2%) still require urinary pads. Four patients (15.4%) have experienced tumor recurrence evidenced only by increased serum prostate-specific antigen levels. Local tumor recurrence with positive biopsy of the urethrovesical junction was diagnosed in 3 patients (11.5%), and 1 (3.8%) experienced systemic tumor recurrence. Conclusions. Radical transcoccygeal prostatectomy is a safe procedure for the surgical treatment of prostate cancer, both from a clinical and a pathologic point of view. Operative complication as well as pathologic features and clinical outcome reported in this series of patients must be related to selection criteria used in most cases. The exact role of radical transcoccygeal prostatectomy in the clinical setting has yet to be defined. According to these preliminary results, radical transcoccygeal prostatectomy should be further investigated in the treatment of incidental carcinoma after transurethral resection of the prostate or suprapubic prostatectomy and could become an elective indication in such cases. (C) 1997, Elsevier Science inc.

Between August 1991 and July 1994, an original balloon-expanding urethral suture guide (24 F) was used in 157 consecutive cases of radical retropubic prostatectomy. Both the instrument and its clinical use are described. This guide guarantees good intraoperative exposure of the sectioned urethral stump during vesical reanastomosis, thus improving the technical feasibility of radical prostatectomy.

During the last 6 years 24 sigmoid colon neobladders were constructed at our institute according to a surgical technique that provides for an optimal spherical configuration of the orthotopic reservoir. All patients underwent radical cystectomy for locally advanced or superficial recurrent bladder cancer. The surgical complication rate was minimal. Mean followup was 38.3 months (range 7 to 70). Patients were evaluated at 9 and 18 months with urodynamic tests. Daytime continence was achieved in 20 of 21 (95.2%) and in 16 of 17 (94.1%) patients, respectively. Nocturnal incontinence was noted in 9 of 21 (42.8%) and 5 of 17 (29.4%) patients. The mean neobladder capacity was 414 cc and 492 cc, respectively. Endoluminal pressure at the maximum reservoir capacity was 31 cm. water (range 23 to 54) and this did not change significantly at 18 months. Minimal post-voiding residual volume was evidenced in all but 1 patient and was maintained at 18 months. Our modified sigmoid colon neobladder is an easy surgical procedure that provides satisfactory total bladder replacement in select patients.

Objective: The aim of this study is to describe (urodynamically) the effect of the use of a 6-branch autologous suburethral sling, made with absorbable sutures and vas deferens, to support the bladder neck and urethra during robot-assisted laparoscopic prostatectomy (RALP) to improve early urinary continence (EUC) recovery. Materials and Methods: Retrograde leak point pressure (RLPP) was intraoperatively evaluated, by means of retrograde perfusion sphincterometry (RPS), in 77 patients (mean age-standard deviation [SD]: 65.64 +/- 7.23 years, mean body mass index +/- SD: 26.69 +/- 3.89) scheduled to undergo RALP at our institution. RLPP was evaluated before (RLPPb) and after pneumoperitoneum induction (RLPPp). RLPP was then evaluated after urethrovesical anastomosis (RLPPa) and after proper sling tensioning (RLPPs), with the aim to obtain the same pressure as after pneumoperitoneum induction. EUC recovery, defined as the use of no pad, was assessed 10 days, 30 days, and 6 months after catheter removal. Results: RPS and proper autologous 6-branch sling positioning were feasible in all patients, without perioperative complications and negligible impact on overall operative time. Pneumoperitoneum induction increased, similarly, RLPP in all patients. An important decrease of sphincteric capability was evident after prostate removal and the following urethrovesical anastomosis, while proper sling tensioning allowed for restoration of sphincteric apparatus capability to its presurgical status (mean RLPPs 40.84 cmH2O vs RLPPp 40.39 cmH2O, p = 0.942). EUC recovery within 10 days after catheter removal was achieved in 59 (77%) patients and progressively improved over time. Conclusions: RPS, intraoperatively performed during RALP, allows for precise evaluation of the impact of the surgical procedure on sphincteric apparatus competence. Moreover, the use of the 6-branch suburethral sling, in association with RPS, allows for restoration of the proper supporting system to the urethral sphincter, similar to the preoperative condition, offering the basis for EUC recovery after radical prostate surgery.

Background: To test the hypothesis that patients with pT2 and positive surgical margins (SM) have a similar biochemical-recurrence (BCR) risk to patients with pT3a, and negative SM. Moreover, we examined the effect of incorporating positive SM as a higher stage on the discrimination accuracy of the current TNM staging system. Materials and methods: We evaluated 1,503 prostate cancer patients treated with radical prostatectomy, between 1998 and 2010. Only individuals with pT2N0 or pT3aN0, without neoadjuvant and/or adjuvant therapy, were included. Cox regression analyses tested the relationship between SM status (negative [R0] vs. positive [R1]) and BCR rate, after stratification according to T stage. Predictive accuracy of the current T stage and of a novel T stage, which consider positive SM as a higher stage, was quantified with Harrell's concordance index. Results: Positive SM rate was 20.3%. The 5-year BCR rates were 96%, 82%, 78%, and 62% for patients with, respectively, pT2R0, pnR1, pT3aR0, and pT3a1 (all P

Background: Peyronie's disease (PD) is a connective tissue disorder of the tunica albuginea (TA). Currently, no gold standard has been developed for the treatment of the disease in its active phase. Objective: To test the effects of a local injection of adipose tissue-derived stem cells (ADSCs) in the active phase of a rat model of PD on the subsequent development of fibrosis and elastosis of the TA and underlying erectile tissue. Design, setting, and participants: A total of 27 male 12-wk-old Sprague-Dawley rats were divided in three equal groups and underwent injection of vehicle (sham), 50-mu g transforming growth factor (TGF)-beta 1 in a 50-mu l vehicle in either a PD or a PD plus ADSC group in the dorsal aspect of the TA. Intervention: The sham and PD groups were treated 1 d after TGF-beta 1 injection with intralesional treatment of vehicle, and the PD plus ADSC group received 1 million human-labeled ADSCs in the 50-mu l vehicle. Five weeks after treatment, six rats per group underwent erectile function measurement. Following euthanasia, penises were harvested for histology and Western blot. Outcome measurements and statistical analysis: The ratio of intracavernous pressure to mean arterial pressure (ICP/MAP) upon cavernous nerve stimulation, elastin, and collagen III protein expression and histomorphometric analysis of the penis. Statistical analysis was performed by analysis of variance followed by the Tukey-Kramer test for post hoc comparisons or the Mann-Whitney test when applicable. Results and limitations: Erectile function significantly improved after ADSC treatment (ICP/MAP 0.37 in PD vs 0.59 in PD plus ADSC at 5-V stimulation; p = 0.03). PD animals developed areas of fibrosis and elastosis with a significant upregulation of collagen III and elastin protein expression. These fibrotic changes were prevented by ADSC treatment. Conclusions: This study is the first to test stem cell therapy in an animal model of PD. Injection of ADSCs into the TA during the active phase of PD prevents the formation of fibrosis and elastosis in the TA and corpus cavernosum. (C) 2012 European Association of Urology. Published by Elsevier B. V. All rights reserved.

PURPOSE: To compare the accuracy of 18F-FACBC and 11C-choline PET/CT in patients radically treated for prostate cancer presenting with biochemical relapse. METHODS: This prospective study enrolled 100 consecutive patients radically treated for prostate cancer and presenting with rising PSA. Of these 100 patients, 89 were included in the analysis. All had biochemical relapse after radical prostatectomy (at least 3 months previously), had 11C-choline and 18F-FACBC PET/CT performed within 1 week and were off hormonal therapy at the time of the scans. The two tracers were compared directly in terms of overall positivity/negativity on both a per-patient basis and a per-site basis. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy were calculated for both the tracers; follow-up at 1 year (including correlative imaging, PSA trend and pathology when available) was considered as the standard of reference. RESULTS: In 51 patients the results were negative and in 25 patients positive with both the tracers, in eight patients the results were positive with 18F-FACBC but negative with 11C-choline, and in five patients the results were positive with 11C-choline but negative with 18F-FACBC. Overall in 49 patients the results were false-negative (FN), in two true-negative, in 24 true-positive (TP) and in none false-positive (FP) with both tracers. In terms of discordances between the tracers: (1) in one patient, the result was FN with 11C-choline but FP with 18F-FACBC (lymph node), (2) in seven, FN with 11C-choline but TP with 18F-FACBC (lymph node in five, bone in one, local relapse in one), (3) in one, FP with 11C-choline (lymph node) but TP with 18F-FACBC (local relapse), (4) in two, FP with 11C-choline (lymph nodes in one, local relapse in one) but FN with 18F-FACBC, and (5) in three, TP with 11C-choline (lymph nodes in two, bone in one) but FN with 18F-FACBC. With 11C-choline and 18F-FACBC, sensitivities were 32 % and 37 %, specificities 40 % and 67 %, accuracies 32 % and 38 %, PPVs 90 % and 97 %, and NPVs 3 % and 4 %, respectively. Categorizing patients by PSA level (

Introduction Extended pelvic lymph node dissection (ePLND) might be associated with damages to the pelvic plexus, potentially affecting erectile function (EF) recovery after radical prostatectomy (RP). However, the impact of the extent of pelvic lymph node dissection (PLND) on EF has never been addressed. Aim The aim of this study is to evaluate the impact of ePLND on potency recovery in patients who underwent bilateral nerve‐sparing RP (BNSRP). Methods The study included 396 patients with prostate cancer treated with BNSRP by two high‐volume surgeons. Patients were retrospectively divided into two groups based on PLND status: no PLND (N = 161; 40.9%) and ePLND (N = 235; 59.1%) at the time of BNSRP. All patients had preoperative functional and oncological data. Univariable and multivariable Cox regression models tested the association between ePLND and EF recovery after surgery, after accounting for confounders. Main Outcome Measure The International Index of Erectile Function (IIEF) was used to evaluate EF after BNSRP. Postoperative EF recovery was defined as an IIEF‐EF domain score ≥22. Results At a mean follow up of 33.2 months after surgery (median 30), 183 patients (46.2%) recovered EF. Overall, postoperative EF recovery rate at 2 years was 48.4%. No significant differences were recorded when patients were stratified according to the extent of PLND (EF recovery rates at 2‐year: 46.6% vs. 49.7% for patients who did not undergo PLND vs. those treated with ePLND; P = 0.33). These results were confirmed at multivariable analyses, where only age at surgery and preoperative IIEF‐EF (all P ≤ 0.03), but not ePLND ( P = 0.8), represented independent predictors of EF recovery. Conclusions The extent of PLND is not associated with potency after BNSRP. Conversely, other factors such as age at surgery and preoperative EF represent the major predictors of postoperative potency recovery. Therefore, when indicated, ePLND can be safely performed without compromising EF outcomes. Gandaglia G, Suardi N, Gallina A, Abdollah F, Capitanio U, Salonia A, Colombo R, Bianchi M, Chun FK, Hansen J, Rigatti P, Montorsi F, and Briganti A. Extended pelvic lymph node dissection does not affect erectile function recovery in patients treated with bilateral nerve‐sparing radical prostatectomy. J Sex Med 2012;9:2187–2194.

Purpose: The association between baseline functional status and urinary continence recovery after radical prostatectomy remains controversial. We tested the hypothesis that baseline erectile and urinary function predicts urinary continence recovery after bilateral nerve sparing radical prostatectomy. Materials and Methods: The study included 752 patients with prostate cancer treated with bilateral nerve sparing radical prostatectomy between 2003 and 2009. All patients had preoperative functional and oncological data available, including age at surgery, body mass index, prostate specific antigen, and erectile and urinary function. Preoperatively erectile and urinary function was assessed by the erectile function domain of the International Index of Erectile Function and the International Prostatic Symptoms Score. Urinary continence was defined as wearing no pads. Univariate and multivariate Cox regression models were used to test the association between predictors and urinary continence recovery after surgery. Results: At a mean postoperative followup of 30.7 months (median 29, range 1 to 80) 611 patients (81.3%) had recovered urinary continence. Overall the urinary continence recovery rate at 1 and 3 years was 73.9% and 82.2%, respectively. On univariate Cox regression analysis patient age and the preoperative score on the erectile function domain of the International Index of Erectile Function were significantly associated with urinary continence recovery (each p

Secondary lymphedema of external male genital organs is a frequent complication of pelvic radical surgery following pelvic lymphadenectomy. Microsurgical lymphovenous anastomoses are usually performed using only the superficial scrotal lymphatics, excluding testicular lymphatic drainage. We have experimented using a new microsurgical technique based on lymphovenous anastomosis between the collectors of the spermatic funiculus and the veins of the pampiniform plexus, allowing testicular lymphatic drainage. The study included 11 patients with external genital organ lymphedema, five of whom were subjected to microsurgical lymphovenous derivation. At 3, 6, and 12 mo after surgery, the patency of lymphovenous anastomoses was assessed by noninvasive lymphography using indocyanine green fluorescence images obtained with the Photodynamic Eye (PDE) infrared camera system (Hamamatsu Photonics K.K., Hamamatsu, Japan). Progressive improvement of clinical conditions was assessed both by patients' self evaluation and by objective clinical follow-up based on: (1) PDE lymphography, (2) tomography of the pubic area, (3) recovery of the soft consistency of the scrotal tissue, (4) recovery of the scrotal skin normochromic aspect, (5) absence of pain, and (6) disappearance of edema with evident reduction of the scrotal and penile dimensions and normal palpability of the testis. The present study shows that lymphovenous anastomosis is a valuable method of resolving the edematous condition. The indocyanine green approach for lymphangiography is a very supportive method during follow-up because, with the least invasive approach, it is possible to ascertain the complete patency of the anastomosis, to confirm its localization, and to assess its lymphatic drainage.

Background: The management of patients with clinical recurrence of prostate cancer after radical prostatectomy (RP) remains challenging. Objective: To determine whether the removal of positive lymph nodes at [11C]choline positron emission tomography/computed tomography (PET/CT) scan may have an impact on the prognosis of patients with biochemical recurrence (BCR) and nodal recurrence after RP. Design, setting, and participants: Prospective analysis of 72 patients affected by BCR after RP associated with a nodal pathologic [11C]choline PET/CT scan. Intervention: Patients underwent salvage lymph node dissection (LND). Measurements: Biochemical response (BR) to treatment was defined as prostate-specific antigen (PSA) < 0.2 ng/ml at 40 d after salvage LND. Kaplan-Meier and Cox regression analyses addressed time to and predictors of clinical recurrence (CR) after salvage LND, respectively. Results and limitations: Overall, 56.9% of patients achieved BR. Mean and median follow-up after LND were 39.4 and 39.8 mo, respectively. The 5-yr BCR-free survival rate was 19%. Preoperative PSA < 4 ng/ml (hazard ratio [HR]: 0.12; p = 0.005), time to BCR < 24 mo (HR: 7.52; p = 0.005), and negative lymph nodes at previous RP (HR: 0.19; p = 0.04) represented independent predictors of BR. Overall, 5-yr CR-free and cancer-specific survival were 34% and 75%, respectively. At multivariable analyses, only PSA >4 ng/ml (HR: 2.13; p = 0.03) and the presence of retroperitoneal uptake at PET/CT scan (HR = 2.92; p = 0.004) represented independent preoperative predictors of CR. Similarly, the presence of pathologic nodes in the retroperitoneum (HR: 2.78; p = 0.02), higher number of positive lymph nodes (HR: 1.04; p = 0.006), and complete BR to salvage LND (HR: 0.31; p = 0.002) represented postoperative independent predictors of CR. Main limitations consisted of the lack of a control group and the heterogeneity of patients included in the analyses. Conclusions: Salvage LND is feasible in patients with BCR after RP and nodal pathologic uptake at [11C]choline PET/CT scan. Biochemical response after surgery can be achieved in a consistent proportion of patients. Although most patients invariably progressed to BCR after surgery at longer follow-up, 35% of patients showed the absence of CR at 5 yr. (C) 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved. "Background: The management of patients with clinical recurrence of prostate cancer after radical prostatectomy (RP) remains challenging. Objective: To determine whether the removal of positive lymph nodes at [11C]choline positron emission tomography/computed tomography (PET/CT) scan may have an impact on the prognosis of patients with biochemical recurrence (BCR) and nodal recurrence after RP. Design, setting, and participants: Prospective analysis of 72 patients affected by BCR after RP associated with a nodal pathologic [11C]choline PET/CT scan. Intervention: Patients underwent salvage lymph node dissection (LND). Measurements: Biochemical response (BR) to treatment was defined as prostate-specific antigen (PSA) < 0.2 ng/ml at 40 d after salvage LND. Kaplan-Meier and Cox regression analyses addressed time to and predictors of clinical recurrence (CR) after salvage LND, respectively. Results and limitations: Overall, 56.9% of patients achieved BR. Mean and median follow-up after LND were 39.4 and 39.8 mo, respectively. The 5-yr BCR-free survival rate was 19%. Preoperative PSA < 4 ng/ml (hazard ratio [HR]: 0.12; p = 0.005), time to BCR < 24 mo (HR: 7.52; p = 0.005), and negative lymph nodes at previous RP (HR: 0.19; p = 0.04) represented independent predictors of BR. Overall, 5-yr CR-free and cancer-specific survival were 34% and 75%, respectively. At multivariable analyses, only PSA >4 ng/ml (HR: 2.13; p = 0.03) and the presence of retroperitoneal uptake at PET/CT scan (HR = 2.92; p = 0.004) represented independent preoperative predictors of CR. Similarly, the presence of pathologic nodes in the retroperitoneum (HR: 2.78; p = 0.02), higher number of positive lymph nodes (HR: 1.04; p = 0.006), and complete BR to salvage LND (HR: 0.31; p = 0.002) represented postoperative independent predictors of CR. Main limitations consisted of the lack of a control group and the heterogeneity of patients included in the analyses. Conclusions: Salvage LND is feasible in patients with BCR after RP and nodal pathologic uptake at [11C]choline PET/CT scan. Biochemical response after surgery can be achieved in a consistent proportion of patients. Although most patients invariably progressed to BCR after surgery at longer follow-up, 35% of patients showed the absence of CR at 5 yr. (C) 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved."

"Background: To our knowledge, the impact of venous tumour thrombus (VTT) consistency in patients affected by renal cell carcinoma (RCC) has never been addressed. Objective: To analyse the effect of VTT consistency on cancer-specific survival (CSS). Design, setting, and participants: We retrospectively analysed 174 consecutive patients with RCC and renal vein or inferior vena cava (IVC) VTT who underwent surgical treatment between 1989 and 2007 at our institute. Intervention: All patients underwent radical nephrectomy and thrombectomy. Measurements: Pathologic specimens were reviewed by a single uropathologist. In addition to traditional pathologic features, the morphologic aspect of the tumour thrombus was evaluated to distinguish solid from friable patterns. The prognostic role of thrombus consistency (solid vs friable) on CSS was assessed by means of Cox regression models. Results and limitations: The VTT was solid in 107 patients (61.5%) and friable in 67 patients (38.5%). The presence of a friable VTT increased the risk of having synchronous nodal or distant metastases, higher tumour grade, higher pathologic stage, and simultaneous perinephric fat invasion (all p < 0.05). The median follow-up was 24 mo. The median CSS was 33 mo; the median CSS was 8 mo in patients with a friable VTT and 55 mo in patients with a solid VTT (p < 0.001). On multivariable analyses, the presence of a friable VTT was an independent predictor of CSS (p = 0.02). The power of our conclusion may be somewhat limited by the relatively small study population and the retrospective nature of the study. Conclusions: In patients with RCC and VTT, the presence of a friable thrombus is an independent predictor of CSS. If our finding is confirmed by further studies, the consistency of the tumour thrombus should be introduced into routine pathologic reports to provide better patient risk stratification. (C) 2011 European Association of Urology. Published by Elsevier B. V. All rights reserved."

PURPOSE OF REVIEW: Despite very good oncological outcomes provided by radical prostatectomy for organ-confined prostate cancer, up to 40% of patients develop a biochemical recurrence (BCR). BCR can be associated with local or distant recurrence of prostate cancer. However, it can be difficult to identify the exact site of recurrence based on traditional diagnostic imaging tools. The introduction of more advanced imaging studies, such as PET/computed tomography scan, has led to the possibility of identifying small sites of recurrence of prostate cancer. Therefore, once the exact site of recurrence has been identified, theoretically new treatment options might be introduced. RECENT FINDINGS: Few studies have addressed the possibility to perform a selective pelvic/retroperitoneal lymph node dissection in patients with BCR associated with the evidence of nodal uptake at PET/computed tomography scan. The results of such studies are conflicting, since some patients seem to benefit from the removal of recurrent lymph nodes, showing temporary prostate-specific antigen response to salvage surgery. On the other hand, other series showed no benefit for such patients related to this surgical approach. Moreover, the identification of the good candidates to salvage lymph node dissection is needed. SUMMARY: Few studies reported a partial or even a complete prostate-specific antigen response to salvage lymph node dissection in patients with nodal recurrence of prostate cancer. However, due to the small number of patients included, to the lack of control groups as well as to the short-term follow-up, to date the available data do not justify the use of this surgical approach out of clinical trials.

The objective was to test the hypothesis that in patients with prostate cancer undergoing radical prostatectomy (RP), diabetic patients are at a higher risk of harboring a high-grade tumor than nondiabetic patients. We examined 2060 consecutive men who underwent RP between 2001 and 2009. Of them, 7.1% had type 2 diabetes mellitus (DM). A high-grade tumor was defined as having a Gleason score >= 8. Univariable and multivariable logistic regression analyses were used to test the relationship between type 2 DM and high-grade tumor. Mean patient age was 64 years (range: 45-85). Mean total PSA level was 9 ng ml(-1) (range: 1-89.5). A significantly higher percentage of diabetic patients had high-grade tumor on biopsy (16.3 vs 7.6%; P=0.001) and on RP specimen (21.1 vs 11.7%; P-0.001) in comparison with non-diabetic patients. In multivariable analyses, DM was an independent predictor of high-grade tumor on biopsy (odds ratio 2.31, P=0.001) and on final pathological specimen (odds ratio 2.22, P=0.002). In patients undergoing RP, those with type 2 DM had a higher risk of harboring a poorly differentiated tumor on final pathological examination. Prostate Cancer and Prostatic Diseases (2011) 14, 74-78; doi: 10.1038/pcan.2010.41; published online 19 October 2010 "The objective was to test the hypothesis that in patients with prostate cancer undergoing radical prostatectomy (RP), diabetic patients are at a higher risk of harboring a high-grade tumor than nondiabetic patients. We examined 2060 consecutive men who underwent RP between 2001 and 2009. Of them, 7.1% had type 2 diabetes mellitus (DM). A high-grade tumor was defined as having a Gleason score >= 8. Univariable and multivariable logistic regression analyses were used to test the relationship between type 2 DM and high-grade tumor. Mean patient age was 64 years (range: 45-85). Mean total PSA level was 9 ng ml(-1) (range: 1-89.5). A significantly higher percentage of diabetic patients had high-grade tumor on biopsy (16.3 vs 7.6%; P=0.001) and on RP specimen (21.1 vs 11.7%; P-0.001) in comparison with non-diabetic patients. In multivariable analyses, DM was an independent predictor of high-grade tumor on biopsy (odds ratio 2.31, P=0.001) and on final pathological specimen (odds ratio 2.22, P=0.002). In patients undergoing RP, those with type 2 DM had a higher risk of harboring a poorly differentiated tumor on final pathological examination. Prostate Cancer and Prostatic Diseases (2011) 14, 74-78; doi: 10.1038\/pcan.2010.41; published online 19 October 2010"

PURPOSE: We assessed the value of [(11)C]choline positron emission tomography/computerized tomography in patients with prostate cancer in whom biochemical failure developed after radical prostatectomy but who showed no disease evidence on conventional imaging. MATERIALS AND METHODS: Considered for this study were 2,124 patients treated with radical prostatectomy who underwent [(11)C]choline positron emission tomography/computerized tomography to restage disease between December 2004 and January 2007. Study inclusion criteria were 1) previous radical prostatectomy and pelvic lymph node dissection, 2) increasing prostate specific antigen beyond 0.2 ng/ml after radical prostatectomy, 3) no lymph node disease at radical prostatectomy, 4) no evidence of metastatic disease on conventional imaging, 5) no androgen deprivation therapy and 6) no adjuvant or salvage radiotherapy. These criteria were satisfied in 109 of the 2,124 patients (5%). RESULTS: Median prostate specific antigen at imaging was 0.81 ng/ml (range 0.22 to 16.76 ml). Imaging suggested local recurrence in 4 patients (4%) and pelvic lymph node disease in 8 (7%). Scans were positive in 5%, 15% and 28% of patients with prostate specific antigen less than 1, between 1 and 2, and greater than 2 ng/ml, respectively (p

Proper patient positioning and port placement is of critical importance in robotic-assisted laparoscopic radical prostatectomy (RALP). Not having the patient in the correct Trendelenburg position or not being able to move the surgical instruments freely in the abdominal cavity can be frustrating, especially for naive robotic surgeons (ie, those at the beginning of the learning curve for this procedure), and can lead to further difficulties in performing the intervention. We describe the use of a nautical inclinometer and a plastic, double-equilateral triangle with an 8-cm-long border to reach the correct Trendelenburg position easily and to place trocars correctly during RALP. (C) 2009 European Association of Urology. Published by Elsevier B.V. All rights reserved. Proper patient positioning and port placement is of critical importance in robotic-assisted laparoscopic radical prostatectomy (RALP). Not having the patient in the correct Trendelenburg position or not being able to move the surgical instruments freely in the abdominal cavity can be frustrating, especially for naive robotic surgeons (ie, those at the beginning of the learning curve for this procedure), and can lead to further difficulties in performing the intervention. We describe the use of a nautical inclinometer and a plastic, double-equilateral triangle with an 8-cm-long border to reach the correct Trendelenburg position easily and to place trocars correctly during RALP. (C) 2009 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Context: Benign prostatic hyperplasia (BPH) is a well-known condition characterised by prostate growth accompanied by lower urinary tract symptoms. Several mechanisms seem to be involved in the development and progression of BPH. Objective: To review the most important findings regarding the key mechanisms involved in the pathophysiology of BPH. Evidence acquisition: During the 2009 annual meeting of the European Association of Urology in Stockholm, Sweden, a satellite symposium was held on BPH and its treatment. This paper is based on one of the presentations at the symposium. A structured, comprehensive literature review was performed using data retrieved from recent review articles, original articles, and abstracts. Evidence synthesis: Several mechanisms seem to be implicated in the pathophysiology of BPH. These represent age-related tissue modifications, hormonal alterations, and metabolic syndrome as well as inflammation. Although androgens do not cause BPH, the development of BPH requires the presence of androgens. Moreover, several studies support the association between noninsulin-dependent diabetes mellitus, hypertension, obesity, and low high-density lipoprotein cholesterol and the development of BPH. Finally, recent increasing evidence seems to support the idea that BPH consists of an inflammatory-based disorder. Inflammation would be initiated by an unknown stimulus that would create a proinflammatory milieu within the gland. This theory is confirmed by several basic research and clinical studies that showed a statistically significant association between inflammation and BPH severity and progression. Conclusions: Although the pathogenesis of BPH is not yet fully understood, several mechanisms seem to be involved in the development and progression of the disease. These mainly include systemic and local hormonal and vascular alterations as well as prostatic inflammation that would stimulate cellular proliferation. Inflammation would be initiated by an unknown stimulus that would create a proinflammatory environment within the prostate. Therefore, from the recent clinical and basic research studies, a novel approach in the clinical management of BPH might focus on the inflammatory process involved in the development and progression of the disease. (C) 2009 Published by Elsevier B. V. on behalf of European Association of Urology. Context: Benign prostatic hyperplasia (BPH) is a well-known condition characterised by prostate growth accompanied by lower urinary tract symptoms. Several mechanisms seem to be involved in the development and progression of BPH. Objective: To review the most important findings regarding the key mechanisms involved in the pathophysiology of BPH. Evidence acquisition: During the 2009 annual meeting of the European Association of Urology in Stockholm, Sweden, a satellite symposium was held on BPH and its treatment. This paper is based on one of the presentations at the symposium. A structured, comprehensive literature review was performed using data retrieved from recent review articles, original articles, and abstracts. Evidence synthesis: Several mechanisms seem to be implicated in the pathophysiology of BPH. These represent age-related tissue modifications, hormonal alterations, and metabolic syndrome as well as inflammation. Although androgens do not cause BPH, the development of BPH requires the presence of androgens. Moreover, several studies support the association between noninsulin-dependent diabetes mellitus, hypertension, obesity, and low high-density lipoprotein cholesterol and the development of BPH. Finally, recent increasing evidence seems to support the idea that BPH consists of an inflammatory-based disorder. Inflammation would be initiated by an unknown stimulus that would create a proinflammatory milieu within the gland. This theory is confirmed by several basic research and clinical studies that showed a statistically significant association between inflammation and BPH severity and progression. Conclusions: Although the pathogenesis of BPH is not yet fully understood, several mechanisms seem to be involved in the development and progression of the disease. These mainly include systemic and local hormonal and vascular alterations as well as prostatic inflammation that would stimulate cellular proliferation. Inflammation would be initiated by an unknown stimulus that would create a proinflammatory environment within the prostate. Therefore, from the recent clinical and basic research studies, a novel approach in the clinical management of BPH might focus on the inflammatory process involved in the development and progression of the disease. (C) 2009 Published by Elsevier B. V. on behalf of European Association of Urology.

OBJECTIVES To examine the association between sex hormone-binding globulin (SHBG) and lymph node invasion (LNI) in patients treated with radical retropubic prostatectomy and extended pelvic lymph node dissection (ePLND). METHODS The preoperative serum SHBG level was measured in a cohort of 168 consecutive patients (mean age 63.9 years, range 48-77) who underwent radical retropubic prostatectomy with ePLND for clinically localized prostate cancer. Logistic regression models tested the association between the predictors (including prostate-specific antigen, clinical stage, primary and secondary biopsy Gleason grades, and SHBG) and LNI. Logistic regression coefficients were used to calculate the predictive accuracy, which was subjected to 200 bootstrap resamples to reduce overfit bias. RESULTS Thirteen patients (7.7%) had LNI. The mean serum SHBG level was significantly greater in the patients with LNI than in those without LNI (50.0 vs 35.1 nmol/L, respectively; P < .001). Univariate analysis indicated that preoperative SHBG was the single most informative predictor of LNI (77.8% vs 71.7% for prostate-specific antigen, 63.9% for clinical stage, and 63.1% and 54.2% for primary and secondary Gleason grade, respectively). On Multivariate analysis, preoperative SHBG was still significantly associated with LNI (P < .001), after accounting for the other variables. The addition of preoperative SHBG increased the predictive accuracy of the base model using clinically established predictors from 72.7% to 82.8% (10.1% gain; P < .001). CONCLUSIONS The results of this study provide novel evidence that SHBG might serve as a significant multivariate predictor of LNI in patients with prostate cancer undergoing ePLND. The use of preoperative serum SHBG could help to identify patients at risk of LNI who should undergo ePLND. UROLOGY 73: 850-855, 2009. (c) 2009 Elsevier Inc. OBJECTIVES To examine the association between sex hormone-binding globulin (SHBG) and lymph node invasion (LNI) in patients treated with radical retropubic prostatectomy and extended pelvic lymph node dissection (ePLND). METHODS The preoperative serum SHBG level was measured in a cohort of 168 consecutive patients (mean age 63.9 years, range 48-77) who underwent radical retropubic prostatectomy with ePLND for clinically localized prostate cancer. Logistic regression models tested the association between the predictors (including prostate-specific antigen, clinical stage, primary and secondary biopsy Gleason grades, and SHBG) and LNI. Logistic regression coefficients were used to calculate the predictive accuracy, which was subjected to 200 bootstrap resamples to reduce overfit bias. RESULTS Thirteen patients (7.7%) had LNI. The mean serum SHBG level was significantly greater in the patients with LNI than in those without LNI (50.0 vs 35.1 nmol/L, respectively; P < .001). Univariate analysis indicated that preoperative SHBG was the single most informative predictor of LNI (77.8% vs 71.7% for prostate-specific antigen, 63.9% for clinical stage, and 63.1% and 54.2% for primary and secondary Gleason grade, respectively). On Multivariate analysis, preoperative SHBG was still significantly associated with LNI (P < .001), after accounting for the other variables. The addition of preoperative SHBG increased the predictive accuracy of the base model using clinically established predictors from 72.7% to 82.8% (10.1% gain; P < .001). CONCLUSIONS The results of this study provide novel evidence that SHBG might serve as a significant multivariate predictor of LNI in patients with prostate cancer undergoing ePLND. The use of preoperative serum SHBG could help to identify patients at risk of LNI who should undergo ePLND. UROLOGY 73: 850-855, 2009. (c) 2009 Elsevier Inc. OBJECTIVES: To examine the association between sex hormone-binding globulin (SHBG) and lymph node invasion (LNI) in patients treated with radical retropubic prostatectomy and extended pelvic lymph node dissection (ePLND).METHODS: The preoperative serum SHBG level was measured in a cohort of 168 consecutive patients (mean age 63.9 years, range 48-77) who underwent radical retropubic prostatectomy with ePLND for clinically localized prostate cancer. Logistic regression models tested the association between the predictors (including prostate-specific antigen, clinical stage, primary and secondary biopsy Gleason grades, and SHBG) and LNI. Logistic regression coefficients were used to calculate the predictive accuracy, which was subjected to 200 bootstrap resamples to reduce overfit bias.RESULTS: Thirteen patients (7.7%) had LNI. The mean serum SHBG level was significantly greater in the patients with LNI than in those without LNI (50.0 vs 35.1 nmol/L, respectively; P < .001). Univariate analysis indicated that preoperative SHBG was the single most informative predictor of LNI (77.8% vs 71.7% for prostate-specific antigen, 63.9% for clinical stage, and 63.1% and 54.2% for primary and secondary Gleason grade, respectively). On multivariate analysis, preoperative SHBG was still significantly associated with LNI (P < .001), after accounting for the other variables. The addition of preoperative SHBG increased the predictive accuracy of the base model using clinically established predictors from 72.7% to 82.8% (10.1% gain; P < .001).CONCLUSIONS: The results of this study provide novel evidence that SHBG might serve as a significant multivariate predictor of LNI in patients with prostate cancer undergoing ePLND. The use of preoperative serum SHBG could help to identify patients at risk of LNI who should undergo ePLND

Purpose of review Holmium laser enucleation of the prostate (HoLEP) has been proposed as an alternative to transurethral resection of the prostate and to open prostatectomy for patients with lower urinary tract symptoms because of large benign prostatic enlargement. The aim of this review is to critically analyze currently available evidence-based reports regarding HoLEP, with particular interest in long-term follow-up results. Recent findings The use of holmium laser for the treatment of benign prostatic hyperplasia was first reported in 1996. HoLEP seems to represent a valid alternative to both transurethral resection of the prostate and open prostatectomy, with valid long-term functional results, a low rate of short-term and long-term complications, and very low rates of reintervention. Summary HoLEP represents a valid alternative to both transurethral resection of the prostate and open prostatectomy for treatment of patients suffering from lower urinary tract symptoms due to benign prostatic enlargement. The recently published long-term follow-up data demonstrate the durability of functional results. HoLEP can be offered as the size-independent gold standard treatment of patients with lower urinary tract symptoms because of benign prostatic enlargement. Purpose of review Holmium laser enucleation of the prostate (HoLEP) has been proposed as an alternative to transurethral resection of the prostate and to open prostatectomy for patients with lower urinary tract symptoms because of large benign prostatic enlargement. The aim of this review is to critically analyze currently available evidence-based reports regarding HoLEP, with particular interest in long-term follow-up results. Recent findings The use of holmium laser for the treatment of benign prostatic hyperplasia was first reported in 1996. HoLEP seems to represent a valid alternative to both transurethral resection of the prostate and open prostatectomy, with valid long-term functional results, a low rate of short-term and long-term complications, and very low rates of reintervention. Summary HoLEP represents a valid alternative to both transurethral resection of the prostate and open prostatectomy for treatment of patients suffering from lower urinary tract symptoms due to benign prostatic enlargement. The recently published long-term follow-up data demonstrate the durability of functional results. HoLEP can be offered as the size-independent gold standard treatment of patients with lower urinary tract symptoms because of benign prostatic enlargement.

Context: Erectile dysfunction (ED) is the complication associated with radical prostatectomy (RP) for clinically localized prostate cancer that has the most negative impact. Currently, several therapeutic options are available to improve sexual health after surgical treatment. Objective: To critically analyze the factors affecting erectile function after RP and to evaluate the evidence suggesting the role of pharmacologic prophylaxis and treatment of ED after surgery. Evidence acquisition: This article is based on the proceeding of the Risk Evaluation and Mitigation Strategy (REMS) meeting held in Madrid, Spain, in 2007. Evidence synthesis: Several basic science reports have highlighted a potential role of phosphodiesterase type 5 inhibitors (PDE5-Is) in the prevention of endothelial damage related to ischemia-reperfusion and/or denervation following surgery. However, patient selection and preservation of both nerves and vascular supply integrity are the major determinants of postoperative erectile function. Pharmacologic treatment of postoperative ED, using either oral or local approaches, is effective and safe. Moreover, recent studies have shown that pharmacologic prophylaxis early after RP can significantly improve the rate of erectile function recovery after surgery. Use of on-demand treatments for treatment of ED in post-RP patients has been shown to be highly effective. in this context, pharmacologic prophylaxis may potentially have a significant expanding role in future strategies aimed at preserving postoperative erectile function. Conclusions: Administration of pro-erectile drugs is the key factor of erectile function recovery after RP. Use of on-demand PDES-Is in post-RP patients has been shown to be effective and safe, with better results seen in select young patients treated with a bilateral nerve-sparing approach. Pharmacologic prophylaxis may have a role in the future. Large, multicentric, placebo-controlled trials are urgently needed in order to identify the best regimen for treating postsurgery ED. (C) 2008 European Association of Urology. Published by Elsevier B.V. All rights reserved. Context: Erectile dysfunction (ED) is the complication associated with radical prostatectomy (RP) for clinically localized prostate cancer that has the most negative impact. Currently, several therapeutic options are available to improve sexual health after surgical treatment. Objective: To critically analyze the factors affecting erectile function after RP and to evaluate the evidence suggesting the role of pharmacologic prophylaxis and treatment of ED after surgery. Evidence acquisition: This article is based on the proceeding of the Risk Evaluation and Mitigation Strategy (REMS) meeting held in Madrid, Spain, in 2007. Evidence synthesis: Several basic science reports have highlighted a potential role of phosphodiesterase type 5 inhibitors (PDE5-Is) in the prevention of endothelial damage related to ischemia-reperfusion and/or denervation following surgery. However, patient selection and preservation of both nerves and vascular supply integrity are the major determinants of postoperative erectile function. Pharmacologic treatment of postoperative ED, using either oral or local approaches, is effective and safe. Moreover, recent studies have shown that pharmacologic prophylaxis early after RP can significantly improve the rate of erectile function recovery after surgery. Use of on-demand treatments for treatment of ED in post-RP patients has been shown to be highly effective. in this context, pharmacologic prophylaxis may potentially have a significant expanding role in future strategies aimed at preserving postoperative erectile function. Conclusions: Administration of pro-erectile drugs is the key factor of erectile function recovery after RP. Use of on-demand PDES-Is in post-RP patients has been shown to be effective and safe, with better results seen in select young patients treated with a bilateral nerve-sparing approach. Pharmacologic prophylaxis may have a role in the future. Large, multicentric, placebo-controlled trials are urgently needed in order to identify the best regimen for treating postsurgery ED. (C) 2008 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Background: Controversies exist about the most appropriate management for patients with incidental prostate cancer after surgery for benign prostatic hyperplasia (BPH). Objectives: To test the accuracy of preoperative clinical variables in predicting the presence of residual disease and biochemical recurrence in patients with incidental prostate cancer treated with radical retropubic prostatectomy. Design, Setting, and Participants: We analyzed 126 T1a-T1b prostate cancers diagnosed at surgery for BPH between 1995 and 2007. Intervention: All patients under-went radical retropubic prostatectomy within 6 mo of surgery for BPH. Measurements: Univariate and multivariate logistic regression models addressed the association between the predictors (age, prostate-specific antigen [PSA] before and after surgery for BPH, T1a-T1b stage, prostate volume, and Gleason score at surgery for BPH) and the presence of residual cancer at radical retropubic prostatectomy. Cox proportional hazards regression analyses tested the relationship between the same predictors and the rate of biochemical recurrence after radical retropubic prostatectomy. Results and Limitations: Seventy-five (59.5%) patients were stage Tla and 51 (40.5%) were stage T1b. At radical retropubic prostatectomy, 21 (16.7%) patients were pT0 and seven (5.6%) patients had extraprostatic disease (pT3). PSA before and after surgery for BPH and Gleason score at surgery for BPH were the only independent predictors of residual cancer at radical retropubic prostatectomy (all p < 0.04). Stage (T1a vs T1b) did not predict residual cancer or the rate of biochemical recurrence. With a mean follow-up of 57 mo, the 5- and 10-yr biochemical recurrence-free survival rates were 92% and 87%, respectively. PSA after surgery for BPH and Gleason score at surgery for BPH were the only significant multivariate predictors of biochemical recurrence (all p < 0.04). The main limitation of this study is the requirement of an external validation before implementation of the clinical recommendations. Conclusion: PSA measured before and after surgery for BPH and Gleason score at surgery for BPH were the only significant predictors of the presence of residual cancer at radical retropubic prostatectomy. PSA measured after surgery for BPH and Gleason score at surgery for BPH were the only independent predictors of biochemical recurrence after radical retropubic prostatectomy. (C) 2008 European Association of Urology. Published by Elsevier B.V. All rights reserved. Background: Controversies exist about the most appropriate management for patients with incidental prostate cancer after surgery for benign prostatic hyperplasia (BPH). Objectives: To test the accuracy of preoperative clinical variables in predicting the presence of residual disease and biochemical recurrence in patients with incidental prostate cancer treated with radical retropubic prostatectomy. Design, Setting, and Participants: We analyzed 126 T1a-T1b prostate cancers diagnosed at surgery for BPH between 1995 and 2007. Intervention: All patients under-went radical retropubic prostatectomy within 6 mo of surgery for BPH. Measurements: Univariate and multivariate logistic regression models addressed the association between the predictors (age, prostate-specific antigen [PSA] before and after surgery for BPH, T1a-T1b stage, prostate volume, and Gleason score at surgery for BPH) and the presence of residual cancer at radical retropubic prostatectomy. Cox proportional hazards regression analyses tested the relationship between the same predictors and the rate of biochemical recurrence after radical retropubic prostatectomy. Results and Limitations: Seventy-five (59.5%) patients were stage Tla and 51 (40.5%) were stage T1b. At radical retropubic prostatectomy, 21 (16.7%) patients were pT0 and seven (5.6%) patients had extraprostatic disease (pT3). PSA before and after surgery for BPH and Gleason score at surgery for BPH were the only independent predictors of residual cancer at radical retropubic prostatectomy (all p < 0.04). Stage (T1a vs T1b) did not predict residual cancer or the rate of biochemical recurrence. With a mean follow-up of 57 mo, the 5- and 10-yr biochemical recurrence-free survival rates were 92% and 87%, respectively. PSA after surgery for BPH and Gleason score at surgery for BPH were the only significant multivariate predictors of biochemical recurrence (all p < 0.04). The main limitation of this study is the requirement of an external validation before implementation of the clinical recommendations. Conclusion: PSA measured before and after surgery for BPH and Gleason score at surgery for BPH were the only significant predictors of the presence of residual cancer at radical retropubic prostatectomy. PSA measured after surgery for BPH and Gleason score at surgery for BPH were the only independent predictors of biochemical recurrence after radical retropubic prostatectomy. (C) 2008 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Objectives: Assess acceptance of and discontinuation rate from erectile dysfunction (ED) treatment in patients after bilateral nerve-sparing radical retropubic prostatectomy (BNSRRP). Methods: We analyzed acceptance and discontinuation data of 100 consecutive, age-comparable, preoperatively self-reported potent BNSRRP patients who at the discharge from the hospital received a phosphodiesterase type 5 inhibitor (PDE5-I) prescription. Patients were informed of the pharmacokinetic properties of the available compounds and the option of on-demand versus rehabilitative therapy. Thereafter, patients did not receive any specific counseling throughout the entire follow-up period and freely decided to use or not use any ED therapy. Complete preoperative data were obtained on hospital admission and included a medical and sexual history and the International index of Erectile Function (IIEF). The IIEF was completed every 6 mo postoperatively, and patients participated in a semi-structured inter-view about the treatment adherence at the 18-mo follow-up. Results: Forty-nine (49%) patients freely decided not to start any ED therapy (group 1). Of the remaining patients, 36 (36%) opted for an as-needed PDE5-I (group 2), whereas 15 (15%) decided to use a daily PDE5-I (group 3). At the 18-mo follow-up, the overall discontinuation rate from both treatment modalities was 72.6% (eg, 72.2% vs. 73.3% in group 2 vs. group 3; p = 0.79). Treatment effect below expectations was the main reason for treatment discontinuation, followed by loss of interest in sex due to partner's causes. Conclusions: Almost 50% of BNSRRP patients freely decided not to start any ED treatment postoperatively. Roughly 73% of patients who started therapy eventually discontinued it. (C) 2007 European Association of Urology. Published by Elsevier B.V. All rights reserved. Objectives: Assess acceptance of and discontinuation rate from erectile dysfunction (ED) treatment in patients after bilateral nerve-sparing radical retropubic prostatectomy (BNSRRP). Methods: We analyzed acceptance and discontinuation data of 100 consecutive, age-comparable, preoperatively self-reported potent BNSRRP patients who at the discharge from the hospital received a phosphodiesterase type 5 inhibitor (PDE5-I) prescription. Patients were informed of the pharmacokinetic properties of the available compounds and the option of on-demand versus rehabilitative therapy. Thereafter, patients did not receive any specific counseling throughout the entire follow-up period and freely decided to use or not use any ED therapy. Complete preoperative data were obtained on hospital admission and included a medical and sexual history and the International index of Erectile Function (IIEF). The IIEF was completed every 6 mo postoperatively, and patients participated in a semi-structured inter-view about the treatment adherence at the 18-mo follow-up. Results: Forty-nine (49%) patients freely decided not to start any ED therapy (group 1). Of the remaining patients, 36 (36%) opted for an as-needed PDE5-I (group 2), whereas 15 (15%) decided to use a daily PDE5-I (group 3). At the 18-mo follow-up, the overall discontinuation rate from both treatment modalities was 72.6% (eg, 72.2% vs. 73.3% in group 2 vs. group 3; p = 0.79). Treatment effect below expectations was the main reason for treatment discontinuation, followed by loss of interest in sex due to partner's causes. Conclusions: Almost 50% of BNSRRP patients freely decided not to start any ED treatment postoperatively. Roughly 73% of patients who started therapy eventually discontinued it. (C) 2007 European Association of Urology. Published by Elsevier B.V. All rights reserved.

As radical prostatectomy (RP) remains a commonly used procedure in the treatment of clinically localized prostate cancer, we critically analyzed the evidence suggesting the role of pharmacological prophylaxis and treatment of erectile dysfunction (ED) after surgery. Systematic literature review using Medline and Cancerlit from January 1997 to December 2006. Abstracts published in the journals European Urology, The Journal of Urology, The International Journal of Impotence Research and The Journal of Sexual Medicine as official proceedings of internationally known scientific Societies held in the same time period were also assessed. Patient selection and surgical technique (i.e., preservation of neurovascular bundles) are the major determinants of post-operative erectile function. Pharmacological treatment of post-operative ED, using either oral or local approaches, is effective and safe. Moreover, recent studies have shown that pharmacological prophylaxis early after RP can significantly improve the rate of erectile function recovery after surgery. Use of on-demand treatments for treatment of ED in patients subjected to RP has been shown to be highly effective, especially in case of properly selected young patients treated with a bilateral nerve-sparing approach by experienced surgeons. In this context, pharmacological prophylaxis may potentially have a significant expanding role in future strategies aimed at preserving post-operative erectile function. As radical prostatectomy (RP) remains a commonly used procedure in the treatment of clinically localized prostate cancer, we critically analyzed the evidence suggesting the role of pharmacological prophylaxis and treatment of erectile dysfunction (ED) after surgery. Systematic literature review using Medline and Cancerlit from January 1997 to December 2006. Abstracts published in the journals European Urology, The Journal of Urology, The International Journal of Impotence Research and The Journal of Sexual Medicine as official proceedings of internationally known scientific Societies held in the same time period were also assessed. Patient selection and surgical technique (i.e., preservation of neurovascular bundles) are the major determinants of post-operative erectile function. Pharmacological treatment of post-operative ED, using either oral or local approaches, is effective and safe. Moreover, recent studies have shown that pharmacological prophylaxis early after RP can significantly improve the rate of erectile function recovery after surgery. Use of on-demand treatments for treatment of ED in patients subjected to RP has been shown to be highly effective, especially in case of properly selected young patients treated with a bilateral nerve-sparing approach by experienced surgeons. In this context, pharmacological prophylaxis may potentially have a significant expanding role in future strategies aimed at preserving post-operative erectile function.

To evaluate technical feasibility and oncologic and functional outcomes of three different surgical procedures of nerve-sparing radical cystectomy (NS-RC) for the treatment of organ-confined bladder cancer at a single referral centre. All consecutive cases of NS-RC carried out between 1997 and 2012 were retrospectively analysed. NS-RC included nerve-sparing cysto-vesicleprostatectomy (NS-CVP), capsule-sparing cystectomy (CS-C) and seminal-sparing cysto-prostatectomy (SS-CP). Peri-operative parameters and post-operative outcomes were analysed. Overall, 90 patients underwent NS-RC, 35 (38.9 %) of whom received a NS-CVP, while 36 (40 %) and 19 (21.1 %) underwent capsule CS-C and SS-CP, respectively. No difference was registered comparing oncologic outcomes of the three different techniques; however, two local recurrences after CS-C were attributed to the surgical technique. Complete post-operative daytime and night-time urinary continence (UC) at 24 and 48 months was achieved in 94.4 and 74.4 % and in 88.8 and 84.4 % of cases, respectively. CS-C showed both the best UC and sexual function preservation rate at early follow-up (24 months). Overall, a satisfactory post-operative erectile function (IIEF-5 ≥ 22) was proved in 57 (68.6 %) and 54 (65.0 %) patients at 24 and 48 months, respectively. Significant difference was found when comparing sexual function preservation rate of NS-CVP (28.5 %) to that of CS-C (91.6 %) and SS-CP (84.2 %). NS-RC for male patients accounted for 7.4 % of overall radical cystectomy. To a limited extent of the selected organ-confined bladder cancers treated, the three different procedures analysed showed comparable results in terms of local recurrence and cancer-specific survival. Both CS-C and SS-CP procedures provided excellent functional outcomes when compared to original NS-CVP.

Introduction and objectives: To systematically analyze and review the available evidence about the potential role of chronic administration of phosphodiesterase type 5 (PDE-5) inhibitors for the cure of erectile dysfunction (ED) based on clinical and basic science data. Methods: Analysis of published full-length papers that were identified with Medline and Cancerlit from January 1993 to September 2005. Abstracts published in the journals European Urology, the Journal of Urology, the International Journal of Impotence Research, and the Journal of Sexual Medicine as official proceedings of internationally known scientific societies held in the same time period were also assessed. Results: Chronic administration of PDE-5 inhibitors have reportedly been associated with increased persistent vascular and endothelial function which represents a key factor in maintaining vascular tone and inducing vasodilation-by increasing the level of endothelial cGMP generated by activation of endothelial nitric oxide. Clinical studies have revealed a potential protective role of these compounds on endothelial function in short- and long-term assessments. Several studies based on animal models have provided direct experimental support for the role of PDE-5 inhibitors in improving the structure and function of the cavernosal tissue and have suggested potential molecular mechanisms involved. Conclusions: Although evidence increasingly supports the potential role of chronic administration of PDE-5 inhibitors for improving erectile function in patients affected by ED, long-term data are lacking. However, data available from animal models support the evidence of potential benefits induced on endothelial function by chronic exposure to PDE-5 inhibitors. (c) 2006 Elsevier B.V. All rights reserved.

Introduction: Our goal was to develop and internally validate a nomogram for prediction of lymph node invasion (LNI) in patients with clinically localized prostate cancer undergoing extended pelvic lymphadenectomy (ePLND). Methods: 602 consecutive patients (mean age 65.8 years) underwent an ePLND, where 10 or more nodes were removed. PSA was 1.1-49.9 (median 7.2). Clinical stages were: T1c in 55.6%, T2 in 41.4% and T3 in 3%. Biopsy Gleason sums were: 6 or less in 66%, 7 in 25.4%, 8-10 in 8.6%. Multivariate logistic regression models tested the association between all of the above predictors and LNI. Regression-based coefficients were used to develop a nomogram predicting LNI and 200 bootstrap resamples were used for internal validation. Results: Mean number of lymph nodes removed was 17.1 (range 10-40). LNI was detected in 66 patients (11.0%). Univariate predictive accuracy for total PSA, clinical stage and biopsy Gleason sum was 63%, 58% and 73%, respectively. A nomogram based on clinical stage, PSA and Biopsy Gleason sum demonstrated bootstrap-corrected predictive accuracy of 76%. Conclusions: A nomogram based on pre-treatment PSA, clinical stage and biopsy Gleason sum can highly accurately predict LNI at ePLND. (c) 2006 Elsevier B.V. All rights reserved.

Objectives: The lipidosterolic extract of Serenoa repens (Permixon (TM)) is commonly used to treat lower urinary tract symptoms related to benign prostatic enlargement. Pertinent peer-reviewed literature was critically analysed with the aim of clarifying the role of Permixon (TM) in view of recent basic science and clinical data. Methods: MEDLINE and Cochrane Library searches were used to assess articles published between 1995 and 2005. The keywords "Serenoa repens," "Saw palmetto," "Permixon (TM)," "benign prostatic hyperplasia," "lower urinary tract symptoms," "chronic prostatitis," and "prostate cancer" were used. Results: The chemical structure of Permixon (TM), its efficacy and tolerability, and the comparative studies between Permixon (TM) and inhibitors of both 5-alpha-reductase and alpha-blockers were considered and discussed. The basic rationale behind the therapeutic effects of Permixon (TM) is sound. Efficacy and safety of the drug are clearly shown. Comparative studies showed similar results between Permixon (TM), alpha-blockers, and finasteride in terms of efficacy. Also the tolerability profile of Permixon (TM) has been shown to be excellent. Conclusions: Although some methodologic limitations hampered the positive results shown in the early studies on Serenoa repens in the treatment of lower urinary tract symptoms due to benign prostatic enlargement, recent sound research clearly revealed the positive role of Permixon (TM). (c) 2006 Elsevier B.V. All rights reserved.

Erectile dysfunction (ED) affects the sexual lives of millions of men. The first-line oral pharmacotherapy for most ED patients is phosphodiesterase type-5 (PDE-5) inhibitors, of which three are available. Sildenafil is the most widely prescribed oral agent for ED and has a very satisfactory efficacy-safety profile in all patient categories. Tadalafil and vardenafil were introduced in the European Union and in the United States in 2003 and 2004, respectively. The three PDE-5 inhibitors share many pharmacological and clinical characteristics, and each has unique features. This review, which is based on the contemporary literature on PDE-5 inhibitors, describes the chemical, pharmacological, and clinical features of sildenafil, vardenafil, and tadalafil. The first section reviews the pathophysiology of penile erection and PDE-5 inhibitor pharmacology. The second section summarizes data regarding efficacy and safety of the three drugs in treating ED in the general population as well as in selected patient categories.