AUA 2023

AUA 2023: Phase 3 Randomized Study of Enzalutamide or Placebo Plus Leuprolide Acetate and Enzalutamide Monotherapy in High-Risk Biochemically Recurrent Prostate Cancer: EMBARK

(UroToday.com) Dr. Neal Shore continued the morning plenary session with an excellent presentation on the late breaking abstract regarding the EMBARK clinical trial for high risk biochemically recurrent prostate cancer. The trial started recruitment in January 2015 and accrued the final patients in August 2018.

AUA 2023: Role and Extent of Pelvic Lymph Node Dissection in PSMA Era

( UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL between April 28 and May 1st, 2023, was host to the Arab Association of Urology sectional session. Dr. Karim A. Touijer discussed the current role of lymphadenectomy in the era of PSMA-PET/CT imaging.

AUA 2023: An Interim Analysis of a Phase II Clinical Study of Intravesical Photo Dynamic Therapy in Patients With BCG-Unresponsive Non-muscle Invasive Bladder Cancer (NMIBC) Carcinoma in-situ (CIS)

(UroToday.com) Dr. Girish Kulkarni presents an interim analysis of a phase II clinical trial of intravesical PDT in BCG-unresponsive NMIBC CIS, with or without papillary disease. As he notes, and many of us understand, novel therapies are required for BCG-unresponsive, high risk non-muscle invasive bladder cancer. Patients are looking for bladder sparing options. One potential option is intravesical Photo Dynamic Therapy (PDT). Herein, they report the interim results of a Phase II Clinical Study of PDT in patients with BCG-unresponsive carcinoma in situ (CIS) (+/- papillary disease).

AUA 2023: Single Port Robotic Assisted Radical Prostatectomy, Technical Point of View

(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL between April 28 and May 1st, 2023, was host to the Arab Association of Urology sectional session. Dr. Jihad Kaouk discussed the latest and most important technical aspects of single port (SP) robotic assisted radical prostatectomy.

AUA 2023: Infectious and Non-Infectious Complications Following Prostate Biopsy: A Randomized Clinical Trial

(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL between April 28 and May 1st, 2023, was host to a late breaking cancer abstract session. Dr. Badar Mian presented the results of a randomized controlled trial comparing infectious and non-infectious complications among patients undergoing a transrectal versus transperineal biopsy.

Clinical Study Results of the BlueWind System for Patients with Overactive Bladder Featured at the 2023 AUA Annual Meeting

  • OASIS study achieves primary and secondary endpoints, safely mitigating the debilitating effects of urgency urinary incontinence
  • Study results show that 78% of those implanted and 82% of patients completing the study achieved at least a 50% reduction in urge incontinence episodes at 12 months
  • At 12 months, 50% of the patients completing the study were 100% dry

Reno, Nevada (UroToday.com) -- BlueWind Medical, Ltd., the developer of a transformative implantable tibial neuromodulation therapy for Overactive Bladder (OAB), announced results from the OASIS pivotal trial evaluating the safety and efficacy of the BlueWind System in the treatment of OAB. The results were featured in the late-breaking session (LBA01-05) at the American Urological Association (AUA) 2023 Annual Meeting in Chicago on Sunday, April 30th.

The presentation at this preeminent Urology conference demonstrates both the unique design of Blue Wind's innovative technology, as well as the strength of the clinical evidence. OASIS, a 151-patient prospective, multicenter, single-arm, open-label clinical study, was designed to demonstrate the safety and efficacy of BlueWind Medical's implantable tibial neuromodulation system in reducing symptoms of urgency urinary incontinence (UUI), including urinary urgency and urinary frequency. Results from the trial are under review by the FDA.

Study Results Highlighted at Conference

BlueWind's OASIS pivotal study successfully met its primary endpoint, demonstrating statistically significant improvement with a 76.4% and 78.4% procedural success rate of at least a 50% reduction in UUI, at 6 and 12 months respectively, in the intention to treat (ITT) analysis (p<.0001). In the completers analysis, at the 12-month follow-up, 82.0 % of participants achieved at least a 50% reduction in UUI episodes, 66.9% achieved at least a 75% reduction, and 50% were dry for at least 3 consecutive days. Notably, there were no procedure or device related serious adverse events and all procedure and device related adverse events were adjudicated by the studies clinical event committee as either mild or moderate. Moreover, the patient-centric nature of the therapy that facilitates individually tailored treatment, resulted in an increasing improvement in UUI over time with 91.6% of patients compliant with once daily treatments at 12 months. These efficacy results, a compelling safety profile combined with a 95% patient reported satisfaction rate, clearly demonstrate the effectiveness of the BlueWind System in reducing OAB symptoms and improving patients' quality of life.

The presentation titled "Pivotal Study of a Novel Wirelessly Powered, Patient Tailored Programmed, Tibial Neurostimulator for the Treatment of Patients with Overactive Bladder," was presented by John Heesakkers, M.D., the primary investigator for the OASIS clinical trial, Chairman of the Department of Urology of the Maastricht UMC, the Netherlands, and the International Continence Society General Secretary.

"As someone who has dedicated their career to advancing urologic care, I am impressed to see the impact that BlueWind's technology is having on patients. It represents a significant step forward in the treatment of OAB, and I have been impressed with the predictability and efficacy of the procedure. I have seen firsthand how patients have experienced relief from their symptoms and have been able to return to a full and active life, and I believe that the BlueWind System has the potential to help many more patients in need," said John Heesakkers, MD.
"We are grateful to the investigators and study participants who made OASIS possible," said Dan Lemaitre, Chief Executive Officer of BlueWind Medical. "The strength of the OASIS data provides great hope that the BlueWind System will provide a compelling therapeutic alternative for the millions of people with OAB who are currently waiting on the side-lines for a more patient-centric and convenient solution to fit their lifestyle. We continue to work with the FDA and look forward to introducing this innovative solution to physicians and patients."

Source: BlueWind Medical. (2023). Clinical Study Results of the BlueWind System for Patients with Overactive Bladder Featured at the 2023 AUA Annual Meeting [Press release]. https://www.prnewswire.com/news-releases/clinical-study-results-of-the-bluewind-system-for-patients-with-overactive-bladder-featured-at-the-2023-aua-annual-meeting-301811486.html.

AUA 2023: Oligometastatic Disease—Who/Why for Directed Therapy

(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL between April 28 and May 1st, 2023, was host to the International Prostate Forum, with Dr. Jeffrey Karnes discussing the role of metastasis-directed therapy for patients with oligometastatic, hormone-sensitive prostate cancer.

AUA 2023: Prostate Cancer in the Middle East

(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL between April 28 and May 1st, 2023, was host to the Arab Association of Urology sectional session. Dr. Waleed Hassen discussed the current state of prostate cancer in the Middle East.

  middle east map 

Dr. Hassen began his presentation by highlighting that while the incidence of prostate cancer may appear low in the Middle East, this is likely secondary to low screening rates and poor public awareness. This is illustrated in the two figures below. The first figure illustrates that the 2020 age-standardized incidence rates of prostate cancer in the Middle Eastern countries are consistently low (light blue shading: <14.5 to 14.5-32.3 diagnoses per 100,000). 

image-1.jpg 

Conversely, it appears that the 2020 age-standardized mortality rates for these countries are disparately higher as demonstrated by the darker orange shading (6.0-10.6 mortalities per 100,000) in the figure below.

global cancer mortality rate map

This issue is further highlighted by a Lebanese study of various malignancies that demonstrates equivalent age-standardized prostate cancer mortality rates for Lebanese men, compared to US men, although the corresponding incidence of prostate cancer in US men was almost three-fold higher, again strongly suggestive of poor screening patterns in this region.

estiamted age graph

The scope of this problem remains poorly understood. Small regional registries from the Middle East show significant variations in the rank order of various malignancies, which may be emblematic of underlying screening patterns, as well as potential genetic and environmental factors.

country by prognosis table

But are incidence rates truly less in this region or is this simply a result of screening/referral patterns? Presented in abstract format at AUA 2017, Hassan et al included a total of 330 screened Arab patients who were referred to Cleveland Clinic Abu Dhabi over a 24-month period. The median age of the cohort was 63 years, of whom 22% were Emirati nationals and 78% from other Middle Eastern countries. Median PSA o the cohort was 8.9 ng/ml (range: 3.4 – 784 ng/ml). Among these 330 patients, the cancer detection rate was 42%:

  • Grade Group 2-3: 50%
  • Grade Group 4 or worse: 24%
  • 17% had metastases at diagnosis 

Given these clear disparities in prostate cancer screening/incidence and mortality rates, modifications to the NCCN guidelines on Prostate Cancer have been proposed and implemented for men in the Middle East and North African region. These guidelines, and others, have highlighted key issues with prostate cancer care in the Middle Eastern region:

  • Lack of screening
    • Most patients present with advanced disease
    • Up to 60% of RP specimens have evidence of pT3 or worse disease
  • Poor access to primary care
    • Reactive, as opposed to a proactive, health system
    • Wide variability in resources, with significant clustering of resources in certain cities
  • Morbidity (e.g., potency and continence) secondary to treatment is unacceptable to many patients
  • Poor surgical training in many Middle Eastern centers
    • Surgical volume and experience have consistently been shown to be associated with improved oncologic and perioperative outcomes1-4
    • Few high-volume centers in the region with surgical training volume lacking
      • Among polled Middle Eastern urologists, 40% reported performing <10 RPs in training

Furthermore, there is a clear shortage of surgical equipment in the region, with <1% of robotic Da Vinci systems in the Arab region. This limitation also extends to the number of radiotherapy machines per capita with 1 – 5 machines per a million people in this region. This issue will only be further exacerbated by the fact that the population of North Africa and The Middle East is estimated to grow from ~450 million currently to 750 by 2050. As such, further resources in this region are clearly needed to “keep up” with the growing population. 

global availability of radiotherapy machines map 

Dr. Hassen concluded his presentation with the following take home messages:

  • While the incidence of prostate cancer appears to be less than that of Western countries, this is likely secondary to awareness/screening patterns as opposed to a truly lower incidence
  • Prostate cancer is a significant source of cancer-related morbidity in this region
  • Numerous obstacles are currently present to deliver what would be deemed “standard of care” to the region 

Presented by: Waleed A. Hassen, MD, Department Chair, Urology, Cleveland Clinic Abu Dhabi, Abu Dhabi, UAE

Written by:  Rashid K. Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2023 American Urological Association (AUA) Annual Meeting, Chicago, IL, April 27 – May 1, 2023

References:
  1. Hu JC, Gold KF, Pashos CL, et al. Role of surgeon volume in radical prostatectomy outcomes. J Clin Oncol 2003;21(3):401-405.
  2. Klein EA, Bianco FJ, Serio AM, et al. Surgeon Experience is Strongly Associated with Biochemical Recurrence after Radical Prostatectomy for all Preoperative Risk Categories. J Urol 2008;179(6):2212-2216.
  3. Alemozaffar M, Duclos A, Hevelone ND, et al. Technical Refinement and Learning Curve for Attenuating Neurapraxia During Robotic-Assisted Radical Prostatectomy to Improve Sexual Function. Eur Urol 2012;61(6):1222-12228.
  4. Ju IE, Trieu D, Chang SB, et al. Surgeon Experience and Erectile Function After Radical Prostatectomy: A Systematic Review. Sex Med Rev 2021;9(4):650-658. 

AUA 2023: Follow-Up Lecture: Somatic Testing — What’s the Difference? Why Bother?

(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL between April 28 and May 1st, 2023, was host to the International Prostate Forum, with Dr. Peter Carroll discussing somatic testing

AUA 2023: Machine Learning Prediction of Symptomatic Kidney Stone Recurrence Using 24-Hour Urine Data and Electronic Health Record Derived Features

(UroToday.com) Mr. Patrick Doyle and colleagues from Vanderbilt University held an excellent presentation on the use of machine learning models in predicting stone recurrence episodes. Although 24-hour (24H) urine studies are currently recommended by AUA Guidelines as an informative measure for the metabolic profile of high-risk stone formers, there exist significant limitations in testing utility, where the value of the test in predicting recurrent stone events is yet to be established. Additionally, further limitations may be present depending upon patient factors and test processing. Provided this discrepancy, Mr. Doyle et al. aimed to evaluate the feasibility of applying machine learning (ML) models to predict symptomatic stone recurrence at 2 and 5 years, as well as assessing which features are utilized by such models.

AUA 2023: A Novel Machine-Learning Algorithm to Predict Stone Recurrence with 24-hour Urine Data

(UroToday.com) Dr. Kevin Shee presented on his team’s efforts to utilize machine learning as a tool to determine the utility of a 24-hour urine test in predicting stone recurrence. The team gathered their training data from the Registry for Stones of the Kidney and Ureter to gather a set of 423 kidney stone patients who had stone event data and 24-hour urine samples. With this dataset, they were able to feed this information to seven prediction classification methods (Decision Tree, Logistic regression with ElasticNet, Extra Trees, kNeighbors, LightGBM, Logistic Regression, and Random Forest) to assess for the most optimal model. In doing so, they used feature importance analyses distills to a 4 variable-model that is easy to use clinically. Additionally, a web interface was created for clinical translation. Upon developing this novel algorithm, they were able to use machine-learning to identify patients who are more likely to experience stone events.

AUA 2023: Ureteral Stent Biomaterial Encrustation after Endoscopic Surgery: A Prospective Randomized Study

(UroToday.com) Dr. Shuzo Hamamoto and his team from Nagoya, Japan spoke on ureteral stents and its adverse effect of encrustation. Ureteral stents are routinely used by all urologists following ureteroscopies as a safety measure ensuring patients can void urine successfully. Stents can be made of different materials to identify and optimize mechanical strength, flexibility, biocompatibility, surface roughness, and cost effectiveness.1 Encrustation is one major drawback when stents are left implanted in a patient for an extended period. Dr. Hamamoto and his team looked to test different stent compositions and their ability to encrust in hopes of finding the optimal stent material that is least likely to stent.

AUA 2023: Efficacy and Safety of a Magnetic Hydrogel for Stone Fragment Removal: An In Vitro and In Vivo Study

(UroToday.com) The 2023 American Urological Association Annual Meeting included a stone disease and surgical therapy session featuring work from Dr. Daniel Massana Roquero and colleagues presenting results of their study investigating the use of a novel integrated stone fragment removal system to decrease stone disease recurrence. While flexible ureteroscopy and laser lithotripsy are the gold standard for treatment of small to medium size stones, there is no management regimen that leads to complete stone clearance on a consistent basis. Flexible stone baskets are used to remove stone fragments after laser lithotripsy; however, these devices are ineffective in removing fragments smaller than 2 mm in diameter. Residual fragments increase the likelihood of stone recurrence. As a potential answer to this issue, Dr. Roquero and colleagues have developed MagSToNE, a system that utilizes a magnetic hydrogel to coat and magnetize stone fragments, as well as a magnetic wire for extraction. Their comparison of MagSToNE to a standard nitinol basket extraction in both an in vitro model and in vivo in a porcine model both evaluates the effectiveness of this system as well as its safety.

AUA 2023: Next Generation Imaging Updates from the RADAR Group

(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL between April 28 and May 1st, 2023, was host to the International Prostate Forum, with Dr. E. David Crawford discussing the history of the Prostate Cancer Radiographic Assessments for Detection of Advanced Recurrence (RADAR) group.

AUA 2023: Urinary Comprehensive Genomic Profiling Aids in Detection and Risk Prognosis of Upper Tract Urothelial Carcinoma: A Case-Controlled Cohort Study

(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL was host to an upper tract transitional cell carcinoma podium session. Dr. Paul Yonover presented the results of a case-control study evaluating urinary comprehensive genomic profiling aids in the detection and risk prognosis of upper tract urothelial carcinoma.

AUA 2023: How to Select Appropriate Candidates in their 70’s for PSA Screening and Curative Treatment versus Observation Strategies

(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, was host to the International Prostate Forum, with Dr. Samuel Washington III discussing how to select appropriate candidates in their seventies for PSA screening and curative treatment versus observation strategies.

AUA 2023: Third Update: What is the Urologists Role for Theranostics?

(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL was host to the International Prostate Forum, with Dr. Thomas Boike discussing the urologist’s role in the field of theranostics.

AUA 2023: Efficacy and Safety of Mitomycin Gel (UGN-101) as an Adjuvant Therapy After Complete Endoscopic Management of Upper Tract Urothelial Carcinoma

(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, was host to an upper tract transitional cell carcinoma podium session. Dr. Craig Labbate presented the results of a study analyzing the efficacy and safety of mitomycin gel (UGN-101) as adjuvant therapy following complete endoscopic management of upper tract urothelial carcinoma (UTUC).

AUA 2023: Gender Disparities in Upper Tract Urothelial Carcinoma

(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL, was host to an upper tract transitional cell carcinoma podium session. Dr. Jeffrey Orf discussed his group’s study evaluating gender disparities in upper tract urothelial carcinoma (UTUC) using the National Cancer Database (NCDB).

AUA 2023: Development of an Individual Postoperative Prediction Model for Kidney Cancer Recurrence Using Machine Learning (UroCCR Study 120)

(UroToday.com) Kidney cancer has seen an increasing incidence globally. Often, it is perceived at the localized stage. Currently, the gold standard modality for kidney cancer is surgical resection of renal cell carcinoma. With its expanding presence and risk for recurrence, it is important to thoroughly understand the prognosis of kidney cancer and develop a management plan that is specific to each patient. The existing prognostic scores have a limited ability to predict accurately, which poses a challenge for urologists to create effective postoperative care strategies and elect patients who would greatly benefit from adjuvant therapy. The need to recognize patients compatible with light surveillance or adjuvant therapy calls for a better prediction system. Dr. Gaelle Margue and her team sought to develop a machine learning model utilized for the purposes of individualized prediction of recurrence risk after surgery (5-year Disease Free Survival after surgery). She delivered a fascinating presentation about their findings at the American Urological Association (AUA) Annual Meeting.