ARNEO: A Randomized Phase II Trial of Neoadjuvant Degarelix with or Without Apalutamide Prior to Radical Prostatectomy for High-risk Prostate Cancer.

BACKGROUND: High-risk prostate cancer (PCa) patients have a high risk of biochemical recurrence and metastatic progression following radical prostatectomy (RP). OBJECTIVE: To determine the efficacy of neoadjuvant degarelix plus apalutamide before RP compared with degarelix with a matching placebo. DESIGN, SETTING, AND PARTICIPANTS: ARNEO was a randomized, placebo-controlled, phase II neoadjuvant trial before RP performed between March 2019 and April 2021. Eligible patients had high-risk PCa and were amenable to RP. INTERVENTION: Patients were randomly assigned at a 1:1 ratio to degarelix (240-80-80 mg) + apalutamide (240 mg/d) versus degarelix + matching placebo for 3 mo followed by RP. Prior to and following neoadjuvant treatment, pelvic 18F-PSMA-1007 positron emission tomography (PET)/magnetic resonance imaging (MRI) was performed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was the difference in proportions of patients with minimal residual disease (MRD; = residual cancer burden (RCB) ≤0.25 cm3 at final pathology). Secondary endpoints included differences in prostate-specific antigen responses, pathological staging, and change in TNM stage on prostate-specific membrane antigen (PSMA) PET/MRI following hormonal treatment. Biomarkers (immunohistochemical staining on prostate biopsy [PTEN, ERG, Ki67, P53, GR, and PSMA] and PSMA PET/MRI-derived characteristics) associated with pathological response (MRD and RCB) were explored. RESULTS AND LIMITATIONS: Patients were randomized to neoadjuvant degarelix + apalutamide (n = 45) or degarelix + matching placebo (n = 44) for 12 wk and underwent RP. Patients in the degarelix + apalutamide arm achieved a significantly higher rate of MRD than those in the control arm (38% vs 9.1%; relative risk [95% confidence interval] = 4.2 [1.5-11], p = 0.002). Patients with PTEN loss in baseline prostate biopsy attained significantly less MRD (11% vs 43%, p = 0.002) and had a higher RCB at final pathology (1.6 vs 0.40 cm3, p < 0.0001) than patients without PTEN loss. Following neoadjuvant hormonal therapy, PSMA PET-estimated tumor volumes (1.2 vs 2.5 ml, p = 0.01) and maximum standardized uptake value (SUVmax; 4.3 vs 5.7, p = 0.007) were lower in patients with MRD than in patients without MRD. PSMA PET-estimated volume and PSMA PET SUVmax following neoadjuvant treatment correlated significantly with RCB at final pathology (both p < 0.001). CONCLUSIONS: In high-risk PCa patients, neoadjuvant degarelix plus apalutamide prior to RP results in a significantly improved pathological response (MRD and RCB) compared with degarelix alone. Our trial results provide a solid hypothesis-generating basis for neoadjuvant phase 3 trials, which are powered to detect differences in long-term oncological outcome following neoadjuvant androgen receptor signaling inhibitor therapy. PATIENT SUMMARY: In this study, we looked at the difference in pathological responses in high-risk prostate cancer patients treated with degarelix plus apalutamide or degarelix plus matching placebo prior to radical prostatectomy. We demonstrated that patients treated with degarelix plus apalutamide achieved a significantly better tumor response than patients treated with degarelix plus matching placebo. Long-term follow-up is required to determine whether improved pathological outcome translates into better oncological outcomes.

Laparoscopic assisted mini-ECIRS for ectopic kidney lithiasis: A case report and literature review.

INTRODUCTION: Ectopic kidney is a rare anatomic variant with an incidence of about 1 in 900. Renal stones can pose a challenge when a standard approach is not possible. Laparoscopic-assisted endourologic procedure can be a feasible and safe choice. CASE REPORT AND LITERATURE REVIEW: We present a case of 32 years old man with spastic quadriplegia, megacolon and pelvic kidney undergoing intervention of laparoscopic-assisted Mini ECIRS for staghorn stone of the left pelvic kidney. To the best of our knowledge, only 59 cases are reported in the literature concerning laparoscopically assisted encdourologic treatment which seems a feasible, safe and adaptable technique in selected complex cases. CONCLUSION: Laparoscopic-assisted mini ECIRS is a viable option for the treatment of ectopic kidney stones. This technique should be considered when anatomical anomalies are encountered, to avoid puncture-related complications.

Reusable, Single-Use, or Both: A Cost Efficiency Analysis of Flexible Ureterorenoscopes After 983 Cases.

Objectives: To determine which flexible ureterorenoscopy program would be most cost-efficient in our center, a cost efficiency analysis and a formula to assess cost efficiency feasibility of a hybrid model were performed. Methods: Total cost per case of reusable flexible ureterorenoscopes (rfURS) was retrospectively calculated and compared with two single-use flexible ureterorenoscopes (sufURS) marketed. A mathematical formula was developed from our data to identify the necessary increase of use of rfURS (NIU-rfURS) to be cost-efficient in a hybrid system utilizing sufURS for only high-risk-of-breakage cases. Results: In 57 months, 983 procedures were performed using 4 digital rfURS (Flex-XC; Storz), necessitating 45 repairs, with a total repair cost of €256.809. Including the capital investment of €24.000 per scope and €60 per sterilization cycle, the cost per case averaged €419 after 983 cases. Consistently using sufURS would have cost 55% to 127% more (respectively, Uscope PU3022® and Lithovue® at €650 and €950 manufacturer suggested retail price). On a per case analysis, the cost was initially extremely high, but declined to reach a plateau around €480 after ∼400 cases. After 155 or 274 procedures, a rfURS program appeared more cost-efficient than consistently using Lithovue or Uscope PU3022, respectively. Based on our data and formula, if we would hypothetically use Uscope PU3022 or Lithovue for 15% of the cases, the NIU-rfURS is, respectively, 28% or 74% (∼6 or 16 cases). The NIU-rfURS increases exponentially with an increased use of sufURS. Conclusion: Consistently using rfURS is more cost-efficient than the constant use of sufURS after 155 to 274 cases. We describe the first mathematical formula that allows a calculation and feasibility assessment of using both reusable and disposable fURS. To identify whether a hybrid system may be a feasible cost-efficient alternative to a rfURS-only program, any center can calculate the NIU-rfURS by entering center-specific data in the formula.

Thiel-embalmed cadavers as a novel training model for ultrasound-guided supine endoscopic combined intrarenal surgery.

OBJECTIVE: To evaluate Thiel-embalmed cadavers (TEC) as a training model for percutaneous nephrolithotomy (PCNL), more specifically for ultrasound (US)-guided supine endoscopic combined intrarenal surgery (ECIRS). SUBJECTS AND METHODS: Thirteen urologists (nine experienced endourologists, four fellows/residents) performed an US-guided supine ECIRS procedure on a TEC. The model was evaluated by way of a questionnaire (5-point Likert scale). Descriptive statistical analysis was performed and results were graphically presented using divergent bar graphs. RESULTS: US images were appreciated as lifelike in all aspects. Although distention of the collecting system was not ideal in one out of three TEC, US visualisation of the distended calyces during puncture was good. Skin penetration was more difficult and less realistic in TEC, while kidney puncture and dilatation were deemed very realistic. Ureteric and collecting system anatomy and consistency were similar to real life, although the mucosa appeared paler. US needle guidance was perceived as excellent. Overall, needle puncture assessment was realistic and useful as a training tool. Overall quality and satisfaction of TEC in US-guided supine ECIRS was good to excellent and comparable to a real-life procedure. Overall appropriateness of the TEC model was considered excellent for both initial and advanced supine PCNL training. CONCLUSION: Despite the minor drawbacks of tough skin and non-ideal collecting system dilatation during ureteroscopy, the TEC model was considered good to excellent as a training model for US-guided PCNL, in particular, US-guided needle puncture of the kidney during supine ECIRS.

Meeting report of the "Symposium on kidney stones and mineral metabolism: calcium kidney stones in 2017".

A symposium on kidney stones and mineral metabolism held on December 2017 in Brussels, Belgium was the first international multidisciplinary conference of the International Collaborative Network on Kidney Stones and Mineral Metabolism. This meeting addressed epidemiology, underlying pathophysiological mechanisms, genetics, pathological, as well as clinical and research topics. The participants included clinicians and recognized experts in the field from Europe and the United States interacted closely during the symposium which promoted a chance to explore new frontiers in the field of kidney stone disease. This manuscript summarizes some of the major highlights of the meeting.

Robot-assisted Kidney Autotransplantation: A Minimally Invasive Way to Salvage Kidneys.

BACKGROUND: Kidney autotransplantation (KAT) is the ultimate way to salvage kidneys with complex renovascular, ureteral, or malignant pathologies that are not amenable to in situ reconstruction. A minimally invasive approach could broaden its adoption. OBJECTIVE: To describe operative technique, perioperative complications, and early functional outcomes of robot-assisted kidney autotransplantation (RAKAT). DESIGN, SETTING, AND PARTICIPANTS: Retrospective review of prospectively collected data regarding consecutive patients undergoing RAKAT between March 2017 and February 2018 at two university hospitals. INTERVENTION: RAKAT. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Technical feasibility, perioperative complications, and early functional results. RESULTS AND LIMITATIONS: Seven patients underwent RAKAT (three male and four female; five left and two right; one totally intracorporeal) for complex ureteral strictures (n=5), severe left renal vein nutcracker (n=1), and loin pain hematuria syndrome (n=1). Two patients underwent bench vascular reconstruction and one patient underwent ex vivo flexible ureterorenoscopy. No patient needed open conversion. Median operative and console time was 370 and 255min, respectively, with median vascular and ureteral anastomosis time of 28 and 23min, respectively. Median warm, cold, and rewarming ischemia time was 2, 178, and 44min, respectively. One major postoperative complication occurred-wound dehiscence needing wound revision (grade 3b). Median hospital stay was 5 d. At 3 mo, all patients were free of indwelling stents, pain, or hematuria. Median serum creatinine at 3 mo was 0.80mg/dl and median calculated autotransplant glomerular filtration rate did not drop significantly. CONCLUSIONS: RAKAT is feasible, safe, and results in good functioning of the autotransplant in selected patients with complex ureteral strictures, loin pain hematuria, or severe nutcracker syndrome. Larger studies with longer follow-up are needed to confirm these findings and to test whether RAKAT is feasible for other KAT indications. PATIENT SUMMARY: We describe the first series worldwide of a minimally invasive technique for kidney autotransplantation. Robot-assisted kidney autotransplantation is a safe and feasible approach to prevent nephrectomy for intractable symptoms in selected patients with complex ureteral or renal pathology.

TRP channels in human prostate.

This review gives an overview of morphological and functional characteristics in the human prostate. It will focus on the current knowledge about transient receptor potential (TRP) channels expressed in the human prostate, and their putative role in normal physiology and prostate carcinogenesis. Controversial data regarding the expression pattern and the potential impact of TRP channels in prostate function, and their involvement in prostate cancer and other prostate diseases, will be discussed.