Postoperative moderately hypofractionated radiotherapy in prostate cancer: a mono-institutional propensity-score-matching analysis between adjuvant and early-salvage radiotherapy.

AIM: To evaluate the impact of moderately hypofractionated postoperative radiotherapy (RT) in prostate cancer (PCa). MATERIALS AND METHODS: The data of 304 surgically resected PCa patients were analyzed. One hundred and five patients underwent adjuvant RT (aRT), 77 early-savage RT (esRT), and 123 salvage RT (sRT). Biochemical relapse-free survival (BRFS), progression-free survival (PFS) and toxicity were analyzed. A propensity score matching (PSM) was performed to account for potential confounders between aRT and esRT groups. RESULTS: The median follow-up was 33 months. Three-year BRFS and PFS were 82 and 85.2%, respectively, in the overall population. At the multivariate analysis, Gleason score and hormone therapy were factors independently correlated with BRFS and PFS. After PSM, there was no difference in BRFS and PFS between aRT and esRT patients. Severe toxicity was represented by grade 3 urinary incontinence (3.5%) and urgency (1%), and aRT correlated with increased any-grade acute toxicity. Severe grade 3 gastrointestinal late toxicity occurred in 1.3% of cases. CONCLUSION: Postoperative moderately hypofractionated RT achieved acceptable disease control rate and demonstrated no increased or unexpected toxicity. Future prospective studies should evaluate the role of postoperative RT in patients with unfavorable disease characteristics.

Total laparoscopic bladder resection in the management of deep endometriosis: "take it or leave it." Radicality versus persistence.

BACKGROUND: Bladder endometriosis (BE) is the most common external site of deep-infiltrating endometriosis (DIE) affecting the urinary tract. Frequently associated with other DIE lesions, it can be strongly related to a ventral spread of adenomyosis. Possible symptoms are urinary frequency, tenesmus and hematuria, and they are frequently related to DIE of the posterior and lateral compartment. Hormonal therapy can be used in non-symptomatic patients; conversely, in other cases surgical treatment is the management of choice. METHODS: Retrospective cohort study of a series of consecutive patients treated between September 2004 and December 2017 in a tertiary care referral center. Only full-thickness detrusor involvement was considered as BE. All patients underwent laparoscopic bladder resection with concomitant radical excision of DIE. RESULTS: BE was found in 264 patients and was associated with simultaneous bowel DIE requiring bowel resection in 140 patients (53%). Twenty-five patients (9.5%) had associated obstructive ureteral signs requiring ureteroneocystostomy. Mean hospital stay and time of catheter removal were 9.7 and 9.1 days, respectively. Postoperative major complications (< 28 days) were observed in 19 patients (7.2%). Follow-up was performed at 1, 6 and 12 months after surgery, with a 2.3% recurrence rate observed. CONCLUSIONS: Laparoscopic partial cystectomy for BE is a feasible and safe technique, and experienced laparoscopic surgeons should consider it the gold standard treatment. Surgical eradication leads to excellent surgical outcomes in terms of reduction of symptoms and recurrence rates, considering the need to maintain an adenomyotic uterus for fertility purposes.

Phase II study of accelerated Linac-based SBRT in five consecutive fractions for localized prostate cancer.

AIM: The goal was to evaluate feasibility, side effects and biochemical no evidence of disease (bNED) after stereotactic body radiation therapy (SBRT) delivered on 5 consecutive days for localized prostate cancer (PC). METHODS: The study was approved by the ethical committee and started in March 2014. Inclusion criteria were age ≤85 years, WHO performance status ≤2, histologically proven adenocarcinoma, low-intermediate risk, no previous surgery (except transurethral resection of the prostate), and a pre-SBRT International Prostatic Symptoms Score of 0-7. The radiotherapy regimen consisted of 35 Gy for low-risk and 37.5 Gy for intermediate-risk PC in 5 consecutive fractions. RESULTS: At the time of the analysis, 52 patients were recruited to the study (median age 73 years, range 55-83 years; median follow-up 34 months, range 12-49 months; 34 patients low-risk and 18 intermediate risk). The median initial prostate-specific antigen (PSA) was 5.9 ng/ml (range 1.8-15.7). Acute genitourinary (GU) toxicity was G0 (grade 0) 36/52 (69%), G1 11/52 (21%), G2 5/52 (10%), while acute rectal (GI) toxicity was G0 43/52 (83%), G1 8/52 (15%), G2 1/52 (2%). No acute toxicity ≥G3 was recorded. At the time of analysis late GU and GI toxicities were as follows: GU-G0 43/52 (83%), GU-G1 7/52 (13%), GU-G2 2/52 (4%); GI-G0 48/52 (92%), GI-G1 2/52 (4%), GI-G2 2/52 (4%). No late toxicities ≥G3 were recorded. bNED was 98%. One patient with intermediate PC had distant progression. CONCLUSIONS: Accelerated SBRT for low-intermediate PC is feasible and well tolerated with comparable oncological outcome as described for other series with the same RT technique but treatment delivery on every other day. Longer follow-up is needed to the assess late toxicity profile and long-term clinical outcome.

Total Laparoscopic Ureteroneocystostomy for Ureteral Endometriosis: A Single-Center Experience of 160 Consecutive Patients.

STUDY OBJECTIVE: To investigate the efficacy of laparoscopic ureteroneocystostomy in patients with deep infiltrating endometriosis (DIE) with ureteral, parametrial, and bowel involvement. DESIGN: Prospective study (Canadian Task Force classification II-2). SETTING: Tertiary referral center for endometriosis care. PATIENTS: One hundred sixty patients with DIE underwent laparoscopic radical eradication and ureteroneocystostomy between January 2009 and December 2016. INTERVENTIONS: Laparoscopic nerve-sparing radical treatment with ureteroneocystostomy, parametrectomy, and, if necessary, segmental bowel resection. MEASUREMENTS AND MAIN RESULTS: Surgical eradication was radical, and ureteral endometriosis was histologically confirmed in all patients (45.6% intrinsic and 54.4% extrinsic). In 58.7% of patients ureteroneocystostomy was performed with the psoas hitch technique. Bowel resection was performed in 121 patients (75.6%), and 115 of them had a concomitant ileostomy (71.9%). Unilateral parametrectomy was performed on the left side in 61.9% of patients and on the right side in 30% of patients, respectively, whereas bilateral parametrectomy was completed in 33 patients (20.6%). Postoperative complications were infrequent: 7 patients underwent reoperation (4.4%), 8 patients experienced fever (5%), 4 patients required blood transfusion (2.5%), 3 patients had intestinal fistulas (1.9%), and 24 patients experienced impaired bladder voiding (15%) after 6 months. Mean follow-up time was 20.5 months (range, 1-60). The study reported good clinical and surgical results, with a regression of symptoms (p < .001) and recurrence of parametrial endometriosis of 1.2% that required opposite-side ureteroneocystostomy. CONCLUSION: This is the largest documented series of patients with DIE undergoing laparoscopic radical eradication and ureteroneocystostomy. The collected data show that in patients with ureteral endometriosis, this technique is feasible, effective, and safe and provides good results in terms of relapses and symptoms' control.

Could 68-Ga PSMA PET/CT become a new tool in the decision-making strategy of prostate cancer patients with biochemical recurrence of PSA after radical prostatectomy? A preliminary, monocentric series.

AIM: To evaluate the impact of gallium68 PSMA-11 (HBED-CC)-PET/CT on decision-making strategy of patients with relapsing prostate cancer (PC) presenting a second biochemical relapse after radical prostatectomy (RP) and salvage RT or salvage androgen deprivation therapy (ADT). MATERIALS AND METHODS: 40 patients were retrospectively analyzed. All of them had received prostatectomy. Thirteen out of 40 were addressed to gallium68 PSMA-11 (HBED-CC)-PET/CT for a biochemical relapse after RP, 14/40 after a salvage RT and 13/40 after salvage or adjuvant ADT. The PSA level ranged between 0.1 and 1.62 ng/ml (median value: 0.51 ng/ml). We studied the impact on the decision-making process of a multidisciplinary tumor board of additional data obtained from gallium68 PSMA-11 (HBED-CC)-PET/CT. RESULTS: Thirty-one out of 40 evaluated patients showed positive findings at gallium68 PSMA-11 (HBED-CC)-PET/CT (77.5%). Of them, five were positive in the prostatic bed, nine in the pelvic nodes, twelve in nodes outside the pelvis and eight at bone level. Nine patients presented two different sites of relapse (22.5%). Gallium68 PSMA-11 (HBED-CC)-PET/CT data changed the therapeutic approach in 28 patients (70%). CONCLUSIONS: Gallium68 PSMA-11 (HBED-CC)-PET/CT can be a useful tool in the restaging of post-RP, RT or ADT patients presenting biochemical relapse of PC and it could change the decision-making process in up of 70% of these patients. Prospective, larger series are needed to establish the correct role of this very promising tool in the staging and therapeutic approach of PC patients.

Outcomes and Postoperative Complications of Robot-Assisted Laparoscopic Hysterosacropexy: Initial Experience.

BACKGROUND: Pelvic organ prolapse is a common condition, affecting about 50% of women with children. The aim of our study was to evaluate results and complication rates in a consecutive series of female patients undergoing robot-assisted laparoscopic hysterosacropexy (RALHSP). MATERIALS AND METHODS: We performed a medical record review of female patients with uterine prolapse who had consecutively undergone RALHSP from February 2010 to 2013 at our department. RESULTS: Fifteen patients were included in the analysis. All patients had uterine prolapse stage ≥ II and urodynamic stress urinary incontinence. The mean age was 58.26 years. According to the Clavien-Dindo system, 4 out of 15 patients (26.6%) had grade 1 early complications and 1 patient had a grade 2 complication. At a median follow-up of 36 months, there was a significant prolapse relapse rate of 20% (3/15). CONCLUSION: In our hands RALHSP is easy to perform, with satisfying mid-term outcomes and a low complication rate.

Prostate volume index and chronic inflammation of the prostate type IV with respect to the risk of prostate cancer.

BACKGROUND: Benign prostatic hyperplasia and prostate cancer (PCA) alter the normal growth patterns of zonal anatomy with changes of prostate volume (PV). Chronic inflammatory infiltrates (CII) type IV are the most common non-cancer diagnosis of the prostate after biopsy. OBJECTIVE: To evaluate associations of both PV index (PVI), i.e. the ratio of transitional zone volume (TZV) to peripheral zone volume (PZV), and CII with PCA in patients undergoing biopsy. SUBJECTS AND METHODS: Between January 2007 and December 2008, 268 consecutive patients who underwent prostate biopsy were retrospectively evaluated. PV and TZV were measured by transrectal ultrasound. PZV was computed by subtracting the PV from the TZV. CII were evaluated according to standard criteria. Significant associations of PVI and the presence of CII (CII+) with PCA risk were assessed by statistical methods. RESULTS AND LIMITATIONS: We evaluated 251 patients after excluding cases with painful rectal examinations, prostate-specific antigen (PSA) >20 µg/ml and metastases. The PCA detection rate was 41.1%. PVI was a negative independent predictor of PCA. A PVI ≤1.0 was directly [odds ratio (OR) = 2.36] associated with PCA, which was detected more frequently in patients with a PVI ≤1.0 (29.1%) than in those with a PVI >1.0 (11.9%). CII+ was inversely (OR = 0.57) and independently associated with PCA, which was detected less frequently in cases with CII (9.9%) than in those without CII (21.1%). Potential study limitations might relate to the fact that PV was not measured by prostatectomy specimens and there was PSA confounding for CII and PCA. CONCLUSIONS: Low values of PVI are directly associated with risk of PCA, which was almost 2.5 times higher in patients with a PVI ≤1.0. The PVI might be an effective parameter for clustering patients at risk of PCA. CII+ was inversely associated with risk of PCA and decreased the probability of detecting PCA by 43%. The role of the PVI and CII in PCA carcinogenesis needs further research.

Associations of pretreatment serum total testosterone measurements with pathology-detected Gleason score cancer.

BACKGROUND AND OBJECTIVE: Prostate cancer is an endocrine-dependent tumor which is still under-investigated for physiopathology factors related to its natural history. The association of pretreatment total testosterone (TT) serum levels with prostate cancer is still a controversial topic. The objective of this study was to investigate potential associations and functional relationships of preoperative TT serum level and pathology-detected Gleason score (pGS). MATERIALS AND METHODS: Pretreatment and pathological variables of 220 patients operated with radical prostatectomy were retrospectively reviewed. Age, prostate-specific antigen (PSA), percentage of positive biopsy cores (P+), biopsy Gleason score (bGS), pGS, TT and free testosterone were the continuous variables, while clinical stage (cT: cT1c, cT2/3), biopsy Gleason pattern (bGP: ≤3+3, 3+4, >3+4), pathology Gleason pattern (pGP: ≤3+3, 3+4, >3+4), pathology stage (pT: pT2, pT3a, pT3b), pathology nodal staging (pN: pN0, pN1, pNx) and surgical margin invasion by cancer (R-, R+) were the categorical variables. Statistical methods were computed for assessing associations of TT and pGS; moreover, simple and multiple linear regression analysis (SLRA and MLRA) were used for assessing functional relationships of TT and pGS. RESULTS: High-grade tumors (pGS ≥8.0) were associated with bGS >6.0 (p < 0.0001), pGP ≥3+4 (p < 0.0001), P+ >0.31% (p = 0.006), cT2/3 (p = 0.01), TT >15.5 nmol/l (p = 0.0004) and, to a lesser extent, PSA >6.27 µg/l (p = 0.06). The odds ratio (OR) ranked as follows: 2.01 (PSA >6.27 µg/l), 2.88 (cT2/3), 3.23 (P+ >0.31%), 5.53 (TT >15.5 nmol/l) and 12.09 (pGP ≥3+4 and pGS ≥8.0). On SLRA, pGS variation was significantly predicted by bGS (p < 0.0001), P+ (p < 0.0001), PSA (p = 0.0005) and TT (p = 0.02); on MLRA, pGS variation was still significantly predicted by bGS (p < 0.0001), P+ (p = 0.04), PSA (p = 0.03) and TT (p = 0.002). When bGS, P+, PSA and TT were dichotomized to their median value, only bGS (p < 0.0001) and TT (p = 0.001) showed independence in predicting pGS variation. The best model for predicting pGS variations was by dichotomizing TT above its median (>15.5 nmol/l) because the predictive coefficient increased to 0.32, which means that patients with TT >15.5 have a significantly higher estimated risk for high-grade pGS than patients with TT ≤15.5 nmol/l (OR = 1.31). CONCLUSION: In a patient population undergoing radical prostatectomy, increased pretreatment serum measurements of TT are associated with and functionally related to high-grade pGS; moreover, baseline TT together with bGS and PSA are important factors for predicting pGS and assessing high-grade tumors. Baseline TT serum levels might have prognostic potential for assessing treatment response for continuous as well as intermittent androgen deprivation therapy.

Fast track surgery to reduce short-term complications following radical cystectomy and intestinal urinary diversion with Vescica Ileale Padovana neobladder: proposal for a tailored enhanced recovery protocol and preliminary report from a pilot study.

OBJECTIVE: Different fast track programs for patients undergoing radical cystectomy (RC) can be found in the current literature. The aim of this work was to develop a new enhanced recovery protocol (ERP). PATIENTS AND METHODS: The ERP was designed after a structured literature review focusing on reduced bowel preparation, standardized feeding, postoperative nausea, vomiting and pain control. In order to test the ERP, a pilot observational prospective cohort study was planned, enrolling all patients consecutively undergoing RC and Vescica Ileale Padovana (VIP) neobladder. These patients were compared with a matched group of subjects who had undergone RC and VIP neobladder before implementation of the ERP. To achieve good comparability, a propensity score-matching was performed. The primary aim was to assess the ERP's feasibility; the secondary outcome measures were early morbidity and mortality. RESULTS AND LIMITATIONS: After an exhaustive literature search and a multidisciplinary consultation, an ERP was designed. Nine consecutive patients participated in the pilot study and were compared to 13 patients treated before implementation of the ERP. We did not find any statistically significant difference in terms of mortality rate (none died peri- or postoperatively in both groups). The complication rate, according to the modified Clavien classification, was significantly lower in the ERP group (22.22 vs. 84.61%, p < 0.004). The major limitations are the low number of patients enrolled to test the protocol and the lack of randomization for the comparative evaluations. CONCLUSION: The introduction of our ERP was proven to be feasible in the management of patients undergoing RC and intestinal urinary diversion with VIP neobladder. The postoperative course was enhanced by a significant reduction in both nasogastric tube insertion and parenteral nutrition support, with early postoperative feeding. All these findings were associated with no deleterious effect on morbidity or mortality, indeed there was a reduced occurrence of postoperative complication rates.

Chronic inflammation of the prostate type IV with respect to risk of prostate cancer.

BACKGROUND: Chronic inflammatory infiltrate (CII) might be involved in prostate cancer (PCA) and benign hyperplasia (BPH); however, its significance is controversial. Chronic inflammatory prostatitis type IV is the most common non cancer diagnosis in men undergoing biopsy because of suspected PCA. OBJECTIVE: To evaluate potential associations of coexistent CII and PCA in biopsy specimens after prostate assessment. DESIGN, SETTING, AND PARTICIPANTS: Between January 2007 and December 2008, 415 consecutive patients who underwent prostate biopsy were retrospectively evaluated. The investigated variables included Age (years) and PSA (ug/l); moreover, CII+, glandular atrophy (GA+), glandular hyperplasia (GH+), prostate Intraepithelial neoplasm (PIN+), atypical small acinar cell proliferation (ASAP+) and PCA positive cores (P+) were evaluated as categorical and continuous (proportion of positive cores). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Associations of CII+ and PCA risk were assessed by statistical methods. RESULTS AND LIMITATIONS: In the patient population, a biopsy core positive for PCA was detected in 34.2% of cases and the rate of high grade PCA (HGPCA: bGS ! 8) resulted 4.82%. CII+ significantly and inversely associated with a positive biopsy core P+ (P < 0.0001; OR = 0.26) and HGPCA (P = 0.0005; OR = 0.05). Moreover, the associations indicated that patients with coexistent CII+ on needle biopsy were 74% less likely to have coexistent PCA than men without CII+ as well as 95% less likely to have HGPCA in the biopsy core than men without coexistent CII+. There were limits in our study which was single centre and included only one dedicated pathologist. CONCLUSIONS: There was an inverse association of chronic inflammation of the prostate type IV and risk of PCA; moreover, HGPCA was less likely to be detected in cancers associated with coexistent CII. In prostate microenvironment, prostate chronic inflammation may be protective; however, its role in PCA carcinogenesis remains controversial and needs further research.

Serum total testosterone is a significant preoperative variable independently contributing to separating the prostate cancer population into prostatectomy Gleason score groups.

AIM: To investigate the potential of preoperative serum total testosterone (TT) in contributing to the definition of separate prostatectomy Gleason score (pGS) groups of the prostate cancer (PCa) population. MATERIALS AND METHODS: The data of 220 patients operated on for PCa were retrospectively reviewed. No patient had previously received 5α-reductase inhibitor, luteinizing hormone-releasing analogs or testosterone replacement treatment. The patient population was grouped according to the pGS as 6 = 3+3, 7 = 3+4, 7 = 4+3 and 8-10. Eight variables were simultaneously investigated in each group: prostate-specific antigen (PSA), TT, free testosterone, age, percentage of positive prostate biopsy cores (P+), biopsy Gleason score (bGS), overall cancer volume estimated as percentage of prostate volume (V+) and prostate weight (Wi). Univariate analysis of variance (ANOVA), multivariate analysis of variance (MANOVA) and multivariate discriminant analysis (MDA) were the statistical methods used for evaluating the data. RESULTS: There were 89 patients in pGS 6 = 3+3, 84 in pGS 7 = 3+4, 24 in pGS 7 = 4+3 and 23 in pGS 8-10. ANOVA showed that bGS (p < 0.0001), P+ (p < 0.0001), V+ (p < 0.0001), PSA (p = 0.0001), Wi (p = 0.0002) and TT (p = 0.01) were significantly different in the four pGS groups. MANOVA tests showed that only bGS (p < 0.0001), V+ (p = 0.0003), TT (p = 0.001) and, to a lesser extent, PSA (p = 0.06) were the significant variables that individually and independently contributed a significant amount to separation of the four pGS groups of the PCa population. MDA showed that the independent variables ranked as bGS (p < 0.0001), TT (p = 0.001), V+ (p = 0.001) and PSA (p = 0.06). CONCLUSIONS: Serum TT is a significant preoperative variable that independently contributes to separating the PCa population into pGS score groups. Pretreatment baseline serum TT levels should be measured and their inclusion in neural networks predicting PCa natural history be considered in the patient population diagnosed with PCa.

Hypofractionated Postoperative Radiotherapy in Prostate Cancer with Ialuril Soft Gels®: Toxicity and Efficacy Analysis on a Retrospective Series of 305 Patients.

Aim: To evaluate the impact of Ialuril soft Gels® (HA) in reducing acute genito-urinary (GU) toxicity in patients treated with adjuvant or salvage radiotherapy for a prostate cancer relapse. Material and Methods: The data of 305 patients were retrospectively collected. One hundred and five patients underwent adjuvant radiotherapy (aRT), while 200 a salvage treatment (sRT). GU toxicity was evaluated according to CTCAE v5.0. Every patient received RT combined with HA. Results: Grade 1-2 GU toxicity during RT was represented by: urgency (36%), dysuria (23%), increased urinary frequency (12.1%), and urinary retention (11.8%). Nevertheless, the majority of symptoms were present at the baseline. Grade 3 severe toxicity was represented by 10 (3.2%) cases of incontinence and 3 (1%) cases of urgency. The incidence of any-grade RT-related GU toxicity was significantly higher in the aRT group than the salvage group (esRT + sRT) (83.8% versus 64.5%). When comparing the incidence of any-grade RT-related GU toxicity in the aRT, esRT, and sRT groups we observed a significant correlation favoring sRT, over esRT, and aRT. Conclusion: Postoperative hypofractionated radiotherapy is safe and not correlated with increase of unexpected toxicity when administered with oral hyaluronic acid. A prospective study is necessary to confirm these results.

Trifecta outcomes after robot-assisted laparoscopic radical prostatectomy.

OBJECTIVE: To evaluate the trifecta outcome and its preoperative predictors in a series of consecutive patients who underwent robot-assisted laparoscopic radical prostatectomy (RALP). PATIENTS AND METHODS: We collected prospectively the clinical data of 242 consecutive patients with a minimum 12-month follow-up undergoing RALP for clinically localized prostate cancer. International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and the International Index of Erectile Function (IIEF)-6 were used to evaluate the functional outcomes. Patients receiving adjuvant therapies or with a PSA at follow-up > 0.2 ng/mL were censored for the biochemical recurrence-free analysis. Logistic regression was used to perform univariable and multivariable analyses. RESULTS: Twelve months after surgery, 216 patients (89%) were continent and 145 (60%) were potent. At a median follow-up of 14 mo, 11 patients (4.5%) had either adjuvant radiation therapies within 3 months of surgery, when PSA was still undetectable (n= 6, 2.5%), or salvage radiation or hormone plus radiation therapy for PSA relapse (n= 5, 2%). A trifecta outcome was achieved by 137 patients (57%). On univariable regression analysis, patients' age at surgery (P < 0.001), body-mass index (P= 0.028), preoperative IIEF-6 score (P < 0.001) and prostate volume (P= 0.036) were significantly associated with trifecta rates. On multivariable analysis, only patients' age at surgery (odds ratio 1.095; P= 0.005) and preoperative IIEF-6 score (odds ratio 0.803; P < 0.001) were independent predictors of trifecta rates. CONCLUSION: Using validated questionnaires to assess functional outcomes, we found that 57% of our patients undergoing nerve-sparing RALP achieved the trifecta outcome 12 months after surgery. Patient age at surgery and preoperative erectile function were the only independent predictors of trifecta rates.

Preoperative criteria to select patients for bilateral nerve-sparing robotic-assisted radical prostatectomy.

INTRODUCTION: To date, no study has analyzed the predictors of potency recovery in a robot-assisted laparoscopic radical prostatectomy (RALP) series. A novel risk stratification for erectile function recovery after retropubic radical prostatectomy (RRP) has been proposed recently by Briganti et al. from the University Vita-Salute San Raffaele in Milan, Italy. AIM: To evaluate the potency rate in a series of consecutive patients who underwent bilateral nerve-sparing RALP, to identify the preoperative predictors of erectile function recovery, and to validate the risk-group stratification of Briganti et al. METHODS: The clinical records of all patients who underwent RALP for clinically localized prostate cancer between April 2005 and April 2009 were prospectively collected in the Prostate Cancer Padua Database. For the present study, we extracted all consecutive cases receiving a bilateral nerve-sparing technique with a minimum follow-up > or =12 months. MAIN OUTCOME MEASURES: Twelve-month potency rate after RALP, defined as an International Index of Erectile Function 6 (IIEF-6) score > or =18. RESULTS: Data showed that 129 out of 208 enrolled patients (62%) were potent 12 months after surgery. Age (hazard ratio [HR]: 2.8; P < 0.001), Charlson score (HR: 2.9; P = 0.007), and baseline IIEF-6 score (HR: 0.8; P < 0.001) were independent predictors of potency recovery at multivariate analysis. According to Briganti et al.'s risk-group stratification, the 12-month potency rate following RALP was 81.9% in the low-risk group, 56.7% in the intermediate-risk group, and 28.6% in the high-risk group (P < 0.001). CONCLUSIONS: In the era of robotic surgery, the key point for the success of the nerve-sparing technique remains the accurate selection of patients. Age < or =65 years, absence of associated comorbidities, and good preoperative erectile function are the most important preoperative factors to select those patients for whom bilateral nerve-sparing RALP can achieve the best results.

Impact of hydrogel peri-rectal spacer insertion on prostate gland intra-fraction motion during 1.5 T MR-guided stereotactic body radiotherapy.

BACKGROUND: The assessment of organ motion is a crucial feature for prostate stereotactic body radiotherapy (SBRT). Rectal spacer may represent a helpful device in order to outdistance rectal wall from clinical target, but its impact on organ motion is still a matter of debate. MRI-Linac is a new frontier in radiation oncology as it allows a superior visualization of the real-time anatomy of the patient and the current highest level of adaptive radiotherapy. METHODS: We present data regarding a total of 100 fractions in 20 patients who underwent MRI-guided prostate SBRT for low-to-intermediate risk prostate cancer with or without spacer. Translational and rotational shifts were computed on the pre- and post-treatment MRI acquisitions referring to the delivery position for antero-posterior, latero-lateral and cranio-caudal direction, and assessed using the Mann-Whitney U-Test. RESULTS: All patients were treated with a five sessions schedule (35 Gy/5fx) using MRI-Linac for a median fraction treatment time of 50 min (range, 46-65). In the entire study sample, median rotational displacement was 0.1° in cranio-caudal, - 0.002° in latero-lateral and 0.01° in antero-posterior direction; median translational shift was 0.11 mm in cranio-caudal, - 0.24 mm in latero-lateral and - 0.22 mm in antero-posterior. A significant difference between spacer and no-spacer patients in terms of rotational shifts in the antero-posterior direction (p = 0.033) was observed; also for translational shifts a positive trend was detected in antero-posterior direction (p = 0.07), although with no statistical significance. We observed statistically significant differences in the pre-treatment planning phase in favor of the spacer cohort for several rectum dose constraints: rectum V32Gy < 5% (p = 0.001), V28 Gy < 10% (p = 0.001) and V18Gy < 35% (p = 0.039). Also for bladder V35 Gy < 1 cc, the use of spacer provided a dosimetric advantage compared to the no-spacer subpopulation (p = 0.04). Furthermore, PTV V33.2Gy > 95% was higher in the spacer cohort compared to the no-spacer one (p = 0.036). CONCLUSION: In our experience, the application of rectal hydrogel spacer for prostate SBRT resulted in a significant impact on rotational antero-posterior shifts contributing to limit prostate intra-fraction motion. Further studies with larger sample size and longer follow-up are required to confirm this ideally favorable effect and to assess any potential impact on clinical outcomes.

Predictors of positive surgical margins after laparoscopic robot assisted radical prostatectomy.

PURPOSE: We identified the predictors of positive surgical margins in a series of patients undergoing robot assisted laparoscopic radical prostatectomy. MATERIALS AND METHODS: We prospectively collected data from 322 patients who underwent robot assisted laparoscopic radical prostatectomy for clinically localized prostate cancer between April 2005 and October 2008, and who had not received any prior hormonal therapy. RESULTS: Positive surgical margins were observed in 95 cases (29.5%). Specifically positive surgical margins were at the apex in 22 cases (6.8%), anterior in 5 (1.6%) and posterolateral in 68 (21%). Among the preoperative variables prostate volume on transrectal ultrasound (HR 0.420, p = 0.002) and cT stage (HR 2.217, p = 0.008) were independent predictors of the presence of any positive surgical margin in the cohort while cT stage (HR 2.070, p = 0.025) and biopsy Gleason score (p = 0.019) were predictors of posterolateral positive surgical margins. Considering pathological variables only extraprostatic extension of the primary tumor was an independent predictor of any positive surgical margin (HR 11.852, p <0.001) and posterolateral positive surgical margins (HR 7.484, p <0.001) in the series. Of those patients with organ confined disease positive surgical margins were present in 21 (10.6%). Only perineural invasion was an independent predictor of any positive surgical margin (HR 4.096, p = 0.028) while a not statistically significant trend was identified with regard to posterolateral positive surgical margins (HR 6.938, p = 0.067). CONCLUSIONS: Pathological extension of the primary tumor was the most relevant predictor of positive surgical margins. In patients with organ confined disease the presence of perineural invasion was significantly associated with positive surgical margins.

Complications and mortality after radical cystectomy for bladder transitional cell cancer.

PURPOSE: We evaluated early postoperative complications and 3-month mortality after radical cystectomy using a standardized method to report complications. MATERIALS AND METHODS: We retrospectively collected data on all 358 consecutive patients who underwent radical cystectomy for nonmetastatic bladder transitional cell carcinoma at a tertiary academic referral center from January 2002 to December 2006. The Martin criteria were used to report complications, which were graded according to a 5-grade modification of the Clavien system. RESULTS: A total of 231 complications occurred in 174 patients (49%), of which 13% were grades 3 to 5. The 3-month mortality rate was 3%. After evaluating the whole patient cohort American Society of Anesthesiologists score was the only covariate significantly associated with grade 3 to 5 complications on univariate analysis. Subgroup analysis limited to patients with an orthotopic ileal neobladder showed that female gender (HR 0.204, p = 0.017) and American Society of Anesthesiologists score (HR 2.851, p = 0.013) were independent predictors of grade 3 to 5 complications on multivariate analysis. CONCLUSIONS: When applying a standardized methodology to report early morbidity, about 50% of patients undergoing radical cystectomy had complications within 3 months of surgery. Although most complications were minor, about 13% of patients experienced grade 3 to 5 events, resulting in a 3-month mortality rate of 3%. American Society of Anesthesiologists score was significantly associated with major complications, while on subgroup analysis in patients who received an orthotopic ileal neobladder female gender was also an independent predictor of major complications.

The 'Stage, Size, Grade and Necrosis' score is more accurate than the University of California Los Angeles Integrated Staging System for predicting cancer-specific survival in patients with clear cell renal cell carcinoma.

OBJECTIVE: To compare the prognostic accuracy of the two most used integrated staging systems to predict the outcome of patients with clear cell renal cell carcinoma (RCC). PATIENTS AND METHODS: We retrospectively evaluated the clinical and pathological data of 388 patients surgically treated for clear cell RCC between 1986 and 2000. The pathological slides of all specimens were reviewed by a pathologist unaware of patient outcome. All patients were classified according to the 'Stage, Size, Grade and Necrosis' (SSIGN) score and University of California Los Angeles Integrated Staging System (UISS) model, and the predictive accuracy of the two models was evaluated using receiver operating characteristics (ROC) curves. RESULTS: The median follow-up was 56 months; the 10-year cancer-specific survival (CSS) probabilities according to the SSIGN score were 96% in the '0-2' category, 78% in the '3-4', 43% in the '5-6', 25.8% in the '7-9' and 0% in the '> or =10' group (P < 0.001). According to the UISS, in nonmetastatic patients the 10-year CSS probabilities were 100% in low, 73% in intermediate and 62% in high-risk groups; in metastatic patients the respective CSS probabilities were 37%, 33% and 12.5% (P < 0.001). The area under the ROC curve (AUC) was 0.870 for the SSIGN score and 0.832 for the UISS. Including only nonmetastatic patients in the analysis, the AUC was 0.830 for the SSIGN score and 0.760 for the UISS model. CONCLUSION: Our study shows for the first time that the SSIGN score offers a better stratification of clear cell RCC than the UISS model. These data should be considered in the design of future randomized controlled trials.

A prospective, non-randomized trial comparing robot-assisted laparoscopic and retropubic radical prostatectomy in one European institution.

OBJECTIVE: To compare the functional results of two contemporary series of patients with clinically localized prostate cancer treated by robot-assisted laparoscopic prostatectomy (RALP) or retropubic radical prostatectomy (RRP). PATIENTS AND METHODS: This was a non-randomized prospective comparative study of all patients undergoing RALP or RRP for clinically localized prostate cancer at our institution from February 2006 to April 2007. RESULTS: We enrolled 105 patients in the RRP and 103 in the RALP group; the two groups were comparable for all clinical and pathological variables, except median age. For RRP and RALP the respective median operative duration was 135 and 185 min (P < 0.001), the intraoperative blood loss 500 and 300 mL (P < 0.001) and postoperative transfusion rates 14% and 1.9% (P < 0.01). There were complications in 9.7% and 10.4% of the patients (P = 0.854) after RRP and RALP, respectively; the positive surgical margin rates in pT2 cancers were 12.2% and 11.7% (P = 0.70). For urinary continence, 41% of patients having RRP and 68.9% of those having RALP were continent at catheter removal (P < 0.001). The 12-month continence rates were 88% after RRP and 97% after RALP (P = 0.01), with the mean time to continence being 75 and 25 days (P < 0.001), respectively. At the 12-month follow-up, 20 of 41 patients having bilateral nerve-sparing RRP (49%) and 52 of 64 having bilateral nerve-sparing RALP (81%) (P < 0.001) had recovery of erectile function. CONCLUSIONS: RALP offers better results than RRP in terms of urinary continence and erectile function recovery, with similar positive surgical margin rates.

Surgical outcomes after modified antegrade scrotal sclerotherapy: a prospective analysis of 700 consecutive patients with idiopathic varicocele.

PURPOSE: We analyzed the surgical outcomes of antegrade scrotal sclerotherapy in a large, prospective, multisurgeon, consecutive series of patients treated for idiopathic varicocele. MATERIALS AND METHODS: We prospectively collected data on 697 consecutive patients undergoing antegrade scrotal sclerotherapy between 1997 and 2005. For every patient we evaluated age, side, clinical and Doppler ultrasound grade, and seminal impairment. Perioperative complications were evaluated 1 month after surgery. At 12 months after antegrade scrotal sclerotherapy all patients underwent Doppler ultrasound. In those with seminal impairment semen analysis was also performed. Failure was defined as at least Doppler grade 1 varicocele. RESULTS: Median age of the 697 analyzed patients was 28 years. Mean surgical time was 15 minutes. All surgeries were performed using local anesthesia and no intraoperative complications were observed. All patients were discharged home within 4 hours. Postoperatively complications developed in 35 patients (5%) and failure occurred in 63 (9%). Persistent reflux was observed in 6.5% of adolescents, in 9.4% of adults and in 7.5% of patients with recurrent varicocele. Failure rates were similar for different grades and sides. The failure rate was significantly higher in patients treated by surgeons during the learning curve (p = 0.007). In the 414 patients with seminal impairment median sperm count and the median percent of progressive motility and normal forms significantly improved after surgery (p <0.001). CONCLUSIONS: Considering the low persistence and complication rates in all patient categories (adolescents, adults, first diagnosis, and bilateral and recurrent disease) antegrade scrotal sclerotherapy can be proposed as a safe and efficacious first choice treatment for varicocele. A specific learning curve is required to achieve the best outcome.