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Objective: To evaluate the effects of switching from prednisone (P) to dexamethasone (D) at asymptomatic prostate-specific antigen (PSA) progression in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone acetate (AA)., Materials and Methods: Among 93 patients treated with AA between January 2013 and April 2016 in our institution, 48 consecutive asymptomatic patients with mCRPC, who experienced biochemical progression on treatment with AA+P 10 mg/day, were included. A corticosteroid switch to AA+D 0.5 mg/day at PSA increase was administered until radiological and/or clinical progression. The primary endpoint was progression-free-survival (PFS). A prognostic score based on independent prognostic factors was defined., Results: The median time to PSA progression on AA+P was 8.94 months. The median PFS on AA+D and AA+corticosteroids (P then D) was 10.35 and 20.07 months, respectively. A total of 56.25% of patients showed a decrease or stabilization in PSA levels after the switch. In univariate analysis, three markers of switch efficiency were significantly associated with a longer PFS: long hormone-sensitivity duration (≥5 years; median PFS 16.62 vs 4.17 months, hazard ratio [HR] 0.30, 90% confidence interval [CI] 0.16-0.56); low PSA level at the time of switch (<50 ng/mL; median PFS 15.21 vs 3.86 months, HR 0.33, 90% CI 0.18-0.60); and short time to PSA progression on AA+P (<6 months; median PFS 28.02 vs 6.65 months, HR 0.41 (90% CI 0.21-0.81). In multivariate analysis, hormone sensitivity duration and PSA level were independent prognostic factors., Conclusion: A steroid switch from P to D appears to be a safe and non-expensive way of obtaining long-term responses to AA in selected patients with mCRPC. A longer PFS has been observed in patients with previous long hormone sensitivity duration, and/or low PSA level and/or short time to PSA progression on AA+P., (© 2018 Institut Mutualiste Montsouris BJU International © 2018 BJU International Published by John Wiley & Sons Ltd.)

Objective: To examine the ability of preoperative clinical characteristics to predict histological features of renal masses (RMs)., Patients and Methods: Data from consecutive patients with clinical stage I RMs treated surgically between 2010 and 2011 in the Clinical Research Office of Endourology Society (CROES) Renal Mass Registry were collected. Based on surgical histology, tumours were categorised as benign, low- or high-aggressiveness cancer. Multivariate logistic regression was used to estimate the probability of the histological group by clinical and radiographic features in the entire cohort and a subcohort of cT1a tumours. The performance of the models was studied by calibration, Nagelkerke's R(2) , and discrimination (area under the receiver operating characteristic curve)., Results: The study cohort included 2 224 patients with a clinical stage I RM, of which 1 367 (61%) were cT1a. Benign lesions were found in 369 (16.6%), low-aggressiveness tumours in 1 156 (52%) and high-aggressiveness tumours in 699 (31.4%). Male gender, smoking history, increased tumour size, and lower exophytic rate were associated with malignancy and high-aggressiveness features (all P < 0.05). Models developed based on these characteristics had the ability to discriminate benign from malignant (bootstrap corrected c-index of 0.64) and high-aggressiveness tumours from benign and low-aggressiveness tumours (bootstrap corrected c-index of 0.66). Similar results were achieved in the cT1a subgroup. The c-index of tumour diameter as a single predictor of malignancy and high-aggressiveness tumours in the entire cohort was 0.6 and 0.63, respectively., Conclusion: Although older age, male gender, smoking history, increased tumour diameter, and reduced exophytic rate are associated with malignancy and high aggressiveness of clinical stage I RMs, models incorporating these characteristics have modest discriminating power, being only slightly better than the predictive ability of tumour size alone., (© 2015 The Authors BJU International © 2015 BJU International Published by John Wiley & Sons Ltd.)

Objective: To determine the optimal drug and light dose for prostate ablation using WST11 (TOOKAD Soluble) for vascular-targeted photodynamic (VTP) therapy in men with low-risk prostate cancer., Patients and Methods: In all, 42 men with low-risk prostate cancer were enrolled in the study but two who underwent anaesthesia for the procedure did not receive the drug or light dose. Thus, 40 men received a single dose of 2, 4 or 6 mg/kg WST11 activated by 200 J/cm light at 753 nm. WST11 was given as a 10-min intravenous infusion. The light dose was delivered using cylindrical diffusing fibres within hollow plastic needles positioned in the prostate using transrectal ultrasonography (TRUS) guidance and a brachytherapy template. Magnetic resonance imaging (MRI) was used to assess treatment effect at 7 days, with assessment of urinary function (International Prostate Symptom Score [IPSS]), sexual function (International Index of Erectile Function [IIEF]) and adverse events at 7 days, 1, 3 and 6 months after VTP. TRUS-guided biopsies were taken at 6 months., Results: In all, 39 of the 40 treated men completed the follow-up. The Day-7 MRI showed maximal treatment effect (95% of the planned treatment volume) in men who had a WST11 dose of 4 mg/kg, light dose of 200 J/cm and light density index (LDI) of >1. In the 12 men treated with these parameters, the negative biopsy rate was 10/12 (83%) at 6 months, compared with 10/26 (45%) for the men who had either a different drug dose (10 men) or an LDI of <1 (16). Transient urinary symptoms were seen in most of the men, with no significant difference in IPSS score between baseline and 6 months after VTP. IIEF scores were not significantly different between baseline and 6 months after VTP., Conclusion: Treatment with 4 mg/kg TOOKAD Soluble activated by 753 nm light at a dose of 200 J/cm and an LDI of >1 resulted in treatment effect in 95% of the planned treatment volume and a negative biopsy rate at 6 months of 10/12 men (83%)., (© 2014 The Authors BJU International © 2014 BJU International Published by John Wiley & Sons Ltd.)

Objectives: To explore the views of experts about the development and validation of a robotic surgery training curriculum, and how this should be implemented., Materials and Methods: An international expert panel was invited to a structured session for discussion. The study was of a mixed design, including qualitative and quantitative components based on focus group interviews during the European Association of Urology (EAU) Robotic Urology Section (ERUS) (2012), EAU (2013) and ERUS (2013) meetings. After introduction to the aims, principles and current status of the curriculum development, group responses were elicited. After content analysis of recorded interviews generated themes were discussed at the second meeting, where consensus was achieved on each theme. This discussion also underwent content analysis, and was used to draft a curriculum proposal. At the third meeting, a quantitative questionnaire about this curriculum was disseminated to attendees to assess the level of agreement with the key points., Results: In all, 150 min (19 pages) of the focus group discussion was transcribed (21 316 words). Themes were agreed by two raters (median agreement κ 0.89) and they included: need for a training curriculum (inter-rater agreement κ 0.85); identification of learning needs (κ 0.83); development of the curriculum contents (κ 0.81); an overview of available curricula (κ 0.79); settings for robotic surgery training ((κ 0.89); assessment and training of trainers (κ 0.92); requirements for certification and patient safety (κ 0.83); and need for a universally standardised curriculum (κ 0.78). A training curriculum was proposed based on the above discussions., Conclusion: This group proposes a multi-step curriculum for robotic training. Studies are in process to validate the effectiveness of the curriculum and to assess transfer of skills to the operating room., (© 2015 The Authors BJU International © 2015 BJU International Published by John Wiley & Sons Ltd.)

Objective: To assess the prognostic significance of positive surgical margins (PSMs) after minimally invasive radical prostatectomy (MIRP) in interaction with other established prognosis factors., Patients and Methods: We retrospectively analysed data prospectively collected between 1998 and 2010 for 4628 consecutive patients who underwent MIRP for clinically localized prostate cancer. The impact of PSM on biochemical recurrence (BCR), defined as prostate-specific antigen (PSA) >0.2 ng/mL, was evaluated using multivariable Cox proportional hazards regression. Estimates of BCR-free survival were generated using the Kaplan-Meier method and compared among groups using the log-rank test., Results: The median follow-up was 55 months. On multivariable analysis, PSM was an independent prognostic factor for BCR (adjusted hazard ratio: 2.14 for PSMs vs negative surgical margins (NSMs); 95% confidence interval [CI]: 1.86-2.45; P < 0.001). Other independent predictors for BCR were preoperative PSA, date of surgery, pT stage, Gleason score and lymph node involvement (all P < 0.001). The 5-year BCR-free probability was 80.6% (95% CI: 79-82.2) for NSMs vs 51% (95% CI: 47-55) for PSMs (log-rank P < 0.001). Patients with pT2 and pT3a PSMs had a similar prognosis to those with pT3a and pT3b NSMs, respectively (log-rank P ≥ 0.05)., Conclusion: A PSM after MIRP is associated with 2.14-fold increased risk of BCR. In patients with pT2 and pT3a disease, a PSM could be considered a pathological upstaging., (© 2013 The Authors. BJU International © 2013 BJU International.)

Objectives: To assess oncological (biochemical and histological recurrence) and functional (urinary and potency) outcomes in patients with unilateral low-risk organ-confined prostate cancer (PCa) treated with focal cryoablation (FC)., Patients and Methods: From January 2009 to March 2012, patients with localized PCa who refused active surveillance were assigned to a FC protocol. This was a prospective, single-arm cohort study. Inclusion criteria were: unilateral disease, clinical stage T1c to T2a, prostate-specific antigen (PSA) concentration <10 ng/mL, low volume index lesion and Gleason score ≤6 (3+3). Hemi-ablation was carried out using the Precise(TM) cryoablation system (Galil Medical, Inc., Arden Hills, MN, USA). Oncological (PSA values) and functional (International Prostate Symptom Score and International Index of Erectile Function (IIEF)-5 score) outcomes were analysed at 3-, 6- and 12-month follow-up. The primary endpoint for oncological efficacy, no cancer in ipsilateral side, was based on the 12-month mandatory biopsy., Results: A total of 48 consecutive patients with a mean age of 67 years were included. The median (interquartile range) follow-up was 13.2 (7.4-26.5) months. Follow-up prostate biopsies were negative for the treated lobe in 86% of patients. The mean PSA concentration dropped significantly at 3 months (by 55%) but did not correlate well with positive biopsy results. Urinary symptoms were unchanged. A slight decrease in the IIEF-5 score was present at 3 months, but did not differ significantly from baseline at 6-month follow-up. There were 15% grade 1 and 4% grade 2 complications (Clavien classification)., Conclusions: Focal cryoablation is a low-morbidity option in selected patients with low-risk PCa. We showed PSA concentration to be an unreliable marker for monitoring FC and recommend a protocol of mandatory biopsies for follow-up. A multicentre randomized controlled trial is necessary to confirm the low-morbidity and the biopsy-proven PCa cure rates., (© 2013 The Authors. BJU International © 2013 BJU International.)

Objectives: To evaluate the optimal treatment conditions and effects of TOOKAD(®) Soluble vascular-targeted photodynamic (VTP) therapy in patients with localised prostate cancer. To evaluate the safety and quality of life after TOOKAD(®) Soluble VTP treatment in patients with localised prostate cancer., Patients and Methods: Men (aged >18 years) diagnosed with localised prostate cancer, who were suitable for active surveillance, were invited to take part in the study. Patients who had received prior or current treatment for their cancer were excluded. There were two parts to the study: in part one, patients were assigned to one of two treatment groups based on the size of their prostates (patients with prostate size <60 mL would receive 4 mg/kg TOOKAD(®) Soluble and patients with prostate size ≥60 mL would receive 6 mg/kg TOOKAD(®) Soluble both activated with 200 J/cm light). In part two, patients were assigned to one of two treatment groups based on predefined criteria and received either 4 or 6 mg/kg TOOKAD(®) Soluble and 200 or 300 J/cm light. VTP was conducted under general anaesthesia using TOOKAD(®) Soluble administered intravenously and activated by light-diffusing fibres within the prostate via the perineum. Follow-up was conducted for 6 months. Magnetic resonance imaging (MRI) carried out at 1 week after VTP and transrectal prostate biopsy at 6 months were the key endpoints. Adverse event (AE) recording and patient-reported outcome measures were collected., Results: In all, 86 patients were enrolled in the study and 85 patients received treatment. Of the 85 treated patients, one patient discontinued (due to withdrawal of consent). At 6 months, 61/83 (74%) patients who underwent prostate biopsy had histopathology that was negative for prostate cancer (95% confidence interval (CI) 62.7-82.6%). Considering patients who received 4 mg/kg TOOKAD(®) Soluble and 200 J/cm light (unilateral), which are considered optimal treatment parameters, 38/46 (83%) patients had histopathology from the biopsies that was negative for prostate cancer at 6 months (95% CI 68.6-92.2%; P < 0.001). The mean percentage of necrosis of the targeted prostate tissue at 7 days after VTP was 78% overall (83 patients) with extraprostatic necrosis reported in 76% (63/83) of patients. Considering patients who received 4 mg/kg TOOKAD(®) Soluble and 200 J/cm light (unilateral), the mean 7-day necrosis percentage was 88% (46 patients) with extraprostatic necrosis reported in 72% (33/46) of patients. All occurrences of extraprostatic necrosis were considered clinically acceptable and none were associated with any clinical sequelae. The mean percentage prostate necrosis at 7 days was statistically significantly higher (P < 0.001) in patients treated with a therapeutic light density index (LDI) of ≥1 than those treated with a LDI of <1. The percentage of patients with negative biopsies at 6 months was also higher in patients treated with a therapeutic LDI of ≥1 than those treated with a LDI of <1 (78.6% and 63.0%, respectively). In all, 87% (75/86) of patients reported at least one treatment-emergent AE during the study. Most AEs were mild or moderate in intensity and considered related to the technical procedures of the study. No treated patients had hypotension or discontinued due to AEs. Eight patients (9.3%) had serious AEs; none resulted in discontinuation from the study., Conclusions: Biopsy data, post-treatment dynamic contrast-enhancement MRI at 1 week after VTP and analysis of the safety data have shown that 4 mg/kg TOOKAD(®) Soluble and 200 J/cm light are the optimal treatment conditions for the VTP procedure resulting in >80% of patients treated with this regimen having a negative biopsy at 6 months. Overall, the treatment was well tolerated and exhibited early signs of efficacy for minimally invasive focal treatment of localised prostate cancer., (© 2013 The Authors. BJU International © 2013 BJU International.)

Objective: • To review and compare the rate, location and size of positive surgical margins (PSMs) after pure laparoscopic radical prostatectomy (LRP) and robot-assisted laparoscopic radical prostatectomy (RALP)., Patients and Methods: • The study comprised 200 patients who underwent RALP and 200 patients who underwent LRP up to January 2008. • We compared patient age, body mass index, preoperative prostate-specific antigen (PSA), preoperative stage and grade, prostate size, pathological stage and grade and neurovascular bundle preservation, as well as PSM rate, size and location. • Continuous and categorical data were compared using Student's t-test and Pearson's chi-squared test. • Multivariate regression analyses were used to identify preoperative and intraoperative predictors of PSMs., Results: • Although the PSM rate was similar between the two groups (LRP: 12% vs RALP: 13.5%; P = 0.76), location and size were not. PSMs after LRP were mostly at the apex (58.3%; P = 0.038), while most PSMs after RALP were posterolateral ([PL] 48%; P = 0.046). • In addition, the median margin size after RALP was significantly smaller than after LRP (RALP: 2 mm vs LRP: 3.5 mm; P = 0.041). • In univariate and multivariate analyses, tumour-node-metastasis (TNM) stage and preoperative PSA were the only independent preoperative predictors of PSMs (P = 0.044 and P = 0.01, respectively)., Conclusion: • The PSM risk is dependent on TNM stage and preoperative PSA and not the surgical technique, when comparing LRP with RALP., (© 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL.)

OBJECTIVE To assess the effect of age and comorbidity on short-term complications, long-term continence and oncological outcome after laparoscopic radical prostatectomy (LRP) for localized prostate cancer. PATIENTS AND METHODS In all, 2048 consecutive men underwent LRP for localized prostate cancer in one institution. Comorbidity was assessed using the Charlson index. Short-term postoperative complications, transfusion rate, duration of hospital stay, long-term continence and oncological outcome were analysed by age and comorbidity classes. RESULTS Of the 2048 men, 297 were aged ≥ 70 years and 281 had a Charlson index of >0 (mainly diabetes 31%, chronic pulmonary disease 26%, prior other nonmetastatic cancer 16%, prior myocardial infarction 12%). Compared with younger men, senior men had significantly higher pathological stages and tumor grades. Of those 297 men aged ≥ 70 years, 90 (30.3%) developed biochemical relapse, none died from prostate cancer and five (1.7%) died from another cause over a median follow-up of 5 years. The occurrence and severity of short-term postoperative complications were more strongly related to comorbidity than chronological age. Multivariate analysis with stepwise regression confirmed that most important predictors of short-term postoperative complications were a Charlson index of ≥ 2, prostate weight of >80 g, obesity and age of ≥ 70 years. Postoperative continence significantly declined with age (ranging from 87% in men aged <60 years to 67.5% in men aged ≥ 70 years). Predictors of long-term incontinence were age of ≥ 70 years, obesity and need for perioperative transfusion. CONCLUSIONS LRP is feasible and effective in fit senior men (aged ≥ 70 years) with localized prostate cancer, including those at high risk of dying from it., (© 2010 THE AUTHORS. JOURNAL COMPILATION © 2010 BJU INTERNATIONAL.)

Objective: To determine the surgical feasibility and early oncological outcomes of laparoscopic distal ureterectomy in patients with low-grade upper urinary tract transitional cell carcinoma (UUT-TCC)., Patients and Methods: We retrospectively reviewed patients treated laparoscopically with conservative management for a UUT-TCC between 2001 and 2005. We collected data on gender, age, mode of diagnosis, smoking, history of bladder cancer, complications, tumour site, size, stage, grade, hospital stay, recurrence and progression., Results: Data were analysed for six patients with a mean (range) age of 68.5 (54-76) years. Four patients had a diagnostic ureteroscopy with biopsy. The operative duration was 173.3 (120-240) min, the estimated blood loss was 75 (50-200) mL and the length of ureteric resection was 5.23 cm. Two patients required a psoas hitch. JJ stents were maintained for 25.8 (15-30) days. The hospital stay was 6 (5-8) days. There were minor complications in three patients after surgery. The follow-up was 32 (17-46) months. The tumour size was 1.7 (0.8-2.6) cm. There were low-grade tumours in four patients and pTa in five. All patients are alive and free of disease; there were no anastomotic strictures. Two patients developed a recurrence, one in the ipsilateral renal pelvis and one in the bladder., Conclusion: Laparoscopic distal ureterectomy with direct re-implantation is technically feasible for low-risk UUT-TCC (i.e. low-grade, noninvasive), in the properly selected patient. Early oncological outcomes are promising but strict surveillance protocols must be followed.