<b><i>Introduction:</i></b> Focal therapy (FT) by high-intensity focused ultrasound (HIFU) is an emerging option for localized prostate cancer (PC). Due to the lack of long-term data, a close monitoring after FT is essential, but there are still uncertainties about the optimal follow-up regimen. Here we report on a series of FT-HIFU patients with the focus on oncological short-term outcome and the value of postoperative magnetic resonance imaging (MRI). <b><i>Methods:</i></b> We included 21 patients treated by FT-HIFU using the Focal One® device (EDAP TMS, France) between November 2015 and May 2018. PC localization was assessed by preoperative multiparametric MRI (mpMRI) and transrectal ultrasound-guided targeted and systematic biopsy. Oncological follow-up included prostate-specific antigen (PSA) development, mpMRI, control biopsies (targeted and systematic) of the treated and untreated areas and salvage treatment rate. Control mpMRI and control biopsy were performed after 6–12 months. <b><i>Results:</i></b> 15 patients (71.4%) were managed by focal ablation of a solitary lesion, while 6 patients (28.6%) underwent zonal tumor ablation. All patients underwent control mpMRI and biopsy. After a mean follow-up period of 11.7 months, cancer relapse was detected in 8 patients (38.1%), with 4 patients (19%) having infield recurrence. Postoperative mpMRI revealed 3 out of 4 infield PC relapses but missed 5 out of 7 outfield relapses. Clinically significant cancer recurrence was present in 1 patient (4.8%), which was missed by mpMRI. Posttreatment mpMRI had a sensitivity, specificity, positive and negative predictive value of 62.5, 92.3, 83.3 and 80.0%, respectively, for overall relapse detection based on patient level. Only 1 of the 8 recurrences was suspected based on PSA progression. 4 of the 8 patients with PC relapse (19%) underwent salvage therapy (2 patients by radical prostatectomy, 2 patients by salvage FT-HIFU). <b><i>Conclusion:</i></b> Postoperative mpMRI might play a valuable role during follow-up after focal HIFU therapy, particularly in terms of infield relapse detection. Irrespective of mpMRI results, the repeat biopsy regimen should incorporate systematic biopsy including cores of the treated and untreated prostate areas.

A.A. and S.F.S. contributed equally to the study. Objective• To externally validate the pT4a-specific risk model for cancer-specific survival (CSS) proposed by May et al. (Urol Oncol 2013; 31: 1141-1147 and to develop a new pT4a-specific nomogram predicting CSS in an international multicentre cohort of patients undergoing radical cystectomy (RC) for urothelial carcinoma of the bladder (UCB) Patients and Methods• Data from 856 patients with pT4a UCB treated with RC at 21 centres in Europe and North-America were assessed. • The risk model proposed by May et al., which includes female gender, presence of positive lymphovascular invasion (LVI) and lack of adjuvant chemotherapy administration as adverse predictors for CSS, was applied to our cohort.• For the purpose of external validation, model discrimination was measured using the receiver-operating characteristic-derived area under the curve.• A nomogram for predicting CSS in pT4a UCB after RC was developed after internal validation based on multivariable Cox proportional hazards regression analysis evaluating the impact of clinicopathological variables on CSS.• Decision-curve analyses were applied to determine the net benefit derived from the two models. Results• The estimated 5-year-CSS after RC was 34% in our cohort.• The risk model devised by May et al. predicted individual 5-year-CSS with an accuracy of 60.1%. • In multivariable Cox proportional hazards regression analysis, female gender (hazard ratio [HR] 1.45), LVI (HR 1.37), lymph node metastases (HR 2.54), positive soft tissue surgical margins (HR 1.39), neoadjuvant (HR 2.24) and lack of adjuvant chemotherapy (HR 1.67, all P < 0.05) were independent predictors of an adverse CSS rate and formed the features of our nomogram with a predictive accuracy of 67.1%.• Decision-curve analyses showed higher net benefits for the use of the newly developed nomogram in our cohort over all thresholds. Conclusions• The risk model devised by May et al. was validated with moderate discrimination and was outperformed by our newly developed pT4a-specific nomogram in the present study population.

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Shock wave lithotripsy (SWL) is the gold standard for the treatment of upper urinary tract stones. Despite being relatively non-invasive, SWL can cause renal hematoma (RHT). The aim of this study was to determine incidence and risk factors for RHT following SWL. 857 patients were included in a prospectively maintained database. The observation period spans from 2007 to 2012. 1,324 procedures were performed due to kidney stones. Treatment protocol included power ramping and shock wave frequency of 60-90 per minute as well as an ultrasound check within 3 days of SWL for all patients. Patients with RHT were analyzed, and treatment characteristics were compared with the complete population in a non-statistical manner due to the low event count. RHTs after SWL, sized between 2.6 × 0.6 cm and 17 × 15 cm, were verified in seven patients (0.53%). In four patients, the RHT was asymptomatic. Three patients developed pain after SWL treatment due to a RHT. In one patient surgical intervention was necessary due to a symptomatic RHT, the kidney was preserved. The risk of RHT following SWL treatment of kidney stones is about 0.5%. Clinically relevant or symptomatic RHTs occur in 0.23%, RHTs requiring surgical intervention are extremely rare. Older age and vascular comorbidities appear to be risk factors for the development of RHT. The technical characteristics of SWL treatment and intake of low-dose acetylsalicylic acid due to an imperative cardiologic indication do not appear to influence the risk. Prospective studies are warranted.

PROOF 302 is an ongoing randomized, double-blind, placebo-controlled, adjuvant phase III trial (NCT04197986) in approximately 218 patients from 120 centers worldwide. Eligibility criteria include post-surgical high-risk muscle-invasive upper tract urothelial cancer (85% of patients) or urothelial bladder cancer (15%), susceptible FGFR3 alterations (activating mutations, gene fusions or rearrangements), ≤120 days following radical surgery and ineligible for/or refusing cisplatin-based (neo)adjuvant chemotherapy. Patients receive either oral infigratinib 125 mg or placebo daily on days 1–21 of a 28-day cycle for up to 52 weeks or until recurrence, unacceptable toxicity or death. Primary end point: centrally determined disease-free survival (DFS); secondary end points: investigator-assessed DFS, metastasis-free survival, overall survival and safety/tolerability; exploratory end points: correlative biomarker analysis, quality-of-life and infigratinib pharmacokinetics.