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Objective: To assess retrospectively the safety and efficacy of an artificial urinary sphincter, the ZSI 375 device (Zephyr Surgical Implants, Geneva, Switzerland), in male patients with moderate-to-severe stress urinary incontinence after a prostate or bladder intervention., Patients and Methods: The ZSI 375 device is a one-piece device consisting of an adjustable cuff, moulded to fit around the urethra, which is connected by a tube to a pump and a pressure-regulating tank. It has no abdominal reservoir. Patients underwent a perineal incision for cuff placement and an inguinal incision for pump and tank scrotal placement. Complications and pads used to manage incontinence were recorded., Results: Between May 2009 and April 2011, 36 patients underwent ZSI 375 device placement. The median (range) follow-up was 15.4 (6-28) months. No patient experienced bladder overactivity, chronic urinary retention, or any other adverse effect after device activation. Complications leading to device removal arose in four patients (one case of erosion, three cases of infection). Social continence (0 or 1 pad/day) was achieved in 28/36 patients (78%) at 3 months and 26/36 patients (73%) at 6 months after device activation. In 12/14 patients for a sphincter closure pressure range of 60-70 cm H2O, in 3/3 patients for a range of 70-80 cm H2O and in 2/11 for a range of 90-100 cm, H2O social continence was achieved only after increasing the pressure of the cuff by trans-scrotal injection of saline., Conclusions: The ZSI 375 device is safe and effective but our follow-up may not have been long enough to identify all potential complications. Further research is needed to confirm these results and extend our investigation, for instance, to the peno-scrotal approach., (© 2012 BJU INTERNATIONAL.)

Objective: To assess the value of endothelin-1 (ET-1) expression in predicting extracapsular extension (ECE) in clinically localized prostate cancer (PCa)., Patients and Methods: ET-1 expression was determined by immunohistochemistry on archival needle biopsies (NBs) from 94 patients (49 pT2 and 45 pT3a) who underwent radical prostatectomy (RP) for clinical T1-T2 PCa. Each sample was analysed independently by two pathologists blinded to the clinical data., Results: In univariate analysis, high ET-1 expression in NBs, pre-operative prostate-specific antigen (PSA) level >10 ng/ml, percentage of positive biopsy cores and NB Gleason score ≥7 were significantly associated with ECE as determined on subsequent RP. No significant association was found between clinical stage and ECE. In multivariate analysis, there was a significant association with high ET-1 expression in NBs (p = 0.006), pre-operative PSA level >10 ng/ml (p = 0.049), and NB Gleason score ≥7 (p = 0.002). These three pre-operative factors combined provided the best model for predicting ECE with 93.3% sensitivity, 49% specificity, 62.5% positive predictive value, 88.9% negative predictive value. The combination yielded a higher concordance index (0.760 vs 0.720) and offered a higher log partial likelihood than the same model without ET1 (112.8 vs 105.7, p = 0.01)., Conclusions: ET-1 expression was strongly associated with ECE and, when combined with pre-operative PSA level and Gleason score, improved the predictive accuracy of pre-operative NBs. Its assessment in patients with localized PCa might be useful when making treatment decisions. Further studies with standardisation of immunohistochemical staining and multi-institutional validation are now needed to establish the appropriate use of ET-1 staining in PCa staging and to evaluate inter-observer reproducibility., (© 2010 THE AUTHORS. BJU INTERNATIONAL © 2010 BJU INTERNATIONAL.)

Objective: • To determine oncological outcomes after high-intensity focused ultrasonography (HIFU) treatment in patients with localized prostate cancer using a new, more accurate, definition ('Stuttgart' definition) of biochemical failure., Patients and Methods: • We performed a retrospective review of all patients in our centre who received first-line treatment with a second-generation Ablatherm™ device (EDAP-TMS, Lyon, France). • Oncological failure was given either by biochemical failure (prostate-specific antigen, PSA, nadir plus 1.2 g/mL) (Stuttgart definition) or the start of salvage therapy because of a persistently positive biopsy after the HIFU procedure. • The 5-year biochemical-free survival rate and 5-year disease-free survival rate were calculated., Results: • In total, 53 patients were included (mean age, 72.5 ± 4.5 years, range 60-79 years; 28 low risk and 25 intermediate risk). None had undergone previous hormonal therapy. Mean ±sd follow-up was 45.4 ± 15.5 months (range 16-71 years). Mean (range) pre-treatment PSA was 8.5 ± 4 (0.29-18) ng/mL. The median (range) PSA nadir value was 1 (0.01-14) ng/mL and occurred after a mean (range) of 5.09 (3-24) months. • Overall, 36 patients (67.9%) experienced oncological failure. • These included 33 cases (62.2%) of biochemical failure. A PSA nadir of ≤0.2, 0.21-1.0 and >1 ng/mL was reached in 20.8%, 30.2% and 49% of patients, respectively, and was associated with biochemical failure in 9.1%, 30.3% and 60.6%, respectively. • The 5-year biochemical-free survival rate and disease-free survival rate were 21.7% and 13.5%, respectively. In multivariate analysis, a PSA nadir of >1 ng/mL was significantly associated with a risk of biochemical and oncological failure (P= 0.002 and P < 0.001). • Oncological failure was not associated with any risk group. • No patient died from prostate cancer., Conclusions: • In our experience, Ablatherm™ treatment for clinically localized prostate cancer was associated with a high rate of biochemical failure as determined by the 'Stuttgart' definition, and did not achieve effective cancer control. • The PSA nadir value after HIFU treatment was a significant predictor of treatment failure., (© 2010 THE AUTHORS. BJU INTERNATIONAL © 2010 BJU INTERNATIONAL.)

Objective: To evaluate the short-term outcomes of the prospective international Prostate Cancer Research International: Active Surveillance ('PRIAS') study (Dutch Trial Register NTR1718), as active surveillance (AS) for early prostate cancer might provide a partial solution to the current overtreatment dilemma in this disease., Patients and Methods: The first 500 (of >950) participants with asymptomatic T1c/T2 prostate cancer, with a prostate-specific antigen (PSA) level of < or =10.0 ng/mL, a PSA density of <0.2 ng/mL/mL, a Gleason score of < or =3 + 3 = 6, and one or two positive biopsy cores, were analysed. The follow-up protocol consisted of frequent PSA measurements, digital rectal examinations, and standard repeat biopsies (the first after 1 year). The primary outcome is survival free of active therapy; the secondary endpoints are reasons for stopping AS, findings in 1-year repeat biopsies, and outcomes after radical prostatectomy (RP)., Results: Patients were included between December 2006 and July 2008. The median (25-75th percentile) follow-up after diagnosis was 1.02 (0.6-1.5) years. The 2-year survival rate free from active therapy was 73%. Of the 82 men who changed to active therapy during the follow-up, 68 (83%) did so based on the protocol. Of the 261 repeat biopsies available for analysis, 90 (34%) showed no cancer, while 57 (22%) showed a Gleason score of >6 or more than two positive biopsy cores. There was a relatively unfavourable PSA doubling time of 0-10 years in 53% (102/194) and 62% (33/53) of men with favourable and unfavourable re-biopsy results, respectively. After RP, four of 24 (17%) men had T3 disease and 12 (50%) had a Gleason score of >6., Conclusion: AS seems feasible, but mortality outcomes are unknown. A strict follow-up protocol including standard 1-year repeat biopsies resulted in a quarter of men stopping AS after 2 years.

Objectives: To assess in a phase II open multicentre study the efficacy and tolerance of docetaxel administered every 14 days combined with celecoxib, in patients with hormone-refractory prostate cancer (HRPC), and to test the hypothesis that this therapeutic combination would improve overall survival., Patients and Methods: In all, 48 patients were included with a mean age of 70.4 years and Gleason score of 7.5, all had a satisfactory Karnofsky performance-status score of 92% and a metastatic bone site was measurable in 77%. The mean delay between initial diagnosis and docetaxel administration was 45 months, with a median PSA level increase of 54.8 ng/mL. The therapeutic schedule was: docetaxel (50 mg/m(2)) administered every 14 days (one cycle of two injections at 2 week intervals (Day 1 = Day 28) with a total of six cycles) and simultaneously a daily oral fixed dose of celecoxib (800 mg)., Results: In all, 237 cycles of docetaxel were administered with a dose reduction in 23 patients at the beginning of a cycle (day 1) and 36 in the middle of a cycle (day 14). The haematological toxicity included anaemia grade 1-2 (78%) and only 10% neutropenia grade 3-4. However, there was only a 15% improvement of pain intensity. The response rate for the total PSA level was 45.5 (30.4-61.1)%, the mean time to progression was 9.3 months and the tumour-response rate was 26.3%. In all, 75% of patients had an overall survival of >14.6 months., Conclusion: Our results confirm the usefulness of docetaxel for HRPC treatment and show a significant reduction of haematological toxicity with bi-weekly docetaxel administration combined with celecoxib.