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ASCO 2019 Annual Meeting

ASCO 2019: A Pilot Safety Study of Gemcitabine and Cisplatin with Atezolizumab as First-Line Therapy in Patients with Metastatic Urothelial Cancer

Chicago, IL (UroToday.com) Combination chemo-immunotherapy has led to benefits in overall survival over chemotherapy alone for both lung cancer and breast cancer. In lung cancer, KEYNOTE-189 showed that patients receiving pemetrexed and a platinum-based drug plus either 200 mg of pembrolizumab had improved overall survival and progression-free survival over chemotherapy alone.1 In IMpassion 130, patients with untreated metastatic triple-negative breast cancer were randomly assigned to receive atezolizumab plus nab-paclitaxel or placebo plus nab-paclitaxel. Those receiving chemoimmunotherapy had a median progression-free survival of 7.2 months with atezolizumab plus nab-paclitaxel, as compared with 5.5 months (hazard ratio (HR) 0.80; 95% confidence interval (CI) 0.69 to 0.92; P=0.002).2 This study examines a similar strategy of chemoimmunotherapy for patients with metastatic urothelial cancer (mUC).

This abstract provides data on 10 patients receiving GC+A. Baseline characteristics are shown below.
ASCO2019_Results_poster385.png
The primary endpoint was safety, as assessed by the dose-limiting toxicity rate during the first cycle for the first 6 patients. There were no dose-limiting toxicities (DLTs) during the first cycle. Grade 3/4 hematologic adverse events such as neutropenia (7/10) and anemia (6/10) occurred in the majority of patients. Only 1 patient discontinued study treatment due to treatment-related adverse events including grade 4 encephalopathy and grade 3 polyneuropathy.
ASCO2019_adverseevents_poster385.png
Of the 10, 9 patients achieved an objective response, of which 5 eventually had progressive disease.
ASCO2019_figure3_poster385.png
Two patients have had very durable responses, with 1 patient without progression at 25 months and one patient status post consolidation surgery with a pathologic complete response (CR) and remains disease-free at 21 months.
ASCO2019_figure4_timeontreatment_poster385.png
After a median follow up of 23.8 months, the median PFS was 10.7 months and median OS has not yet been reached.
ASCO2019_figure1progressionfree_poster385.png
The results of these first 10 patients demonstrate that GC+A is relatively tolerable for patients with only one discontinuation due to toxicity. The neoadjuvant study with GC+A is ongoing. A larger single arm study had been reported for the combination of gem/cis plus ipilimumab and a similarly high number of grade 3/4 AEs were reported there as well (81%). Two large phase III studies, KEYNOTE 361 (NCT02853305) and IMvigor 130 (NCT02807636), are now underway to evaluate chemoimmunotherapy vs. chemotherapy for mUC.

Presented by: Samuel Aaron Funt, MD, Memorial Sloan Kettering, New York, NY 

Written by: Jason Zhu, MD, Fellow, Division of Hematology and Oncology, Duke University, @TheRealJasonZhu at the 2019 ASCO Annual Meeting #ASCO19, May 31- June 4, 2019, Chicago, IL USA

References:
  1. Gandhi L, Rodríguez-Abreu D, Gadgeel S, et al. Pembrolizumab plus chemotherapy in metastatic non–small-cell lung cancer. New England journal of medicine 2018;378:2078-92.
  2. Schmid P, Adams S, Rugo HS, et al. Atezolizumab and nab-paclitaxel in advanced triple-negative breast cancer. New England Journal of Medicine 2018;379:2108-21.
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Results from the Phase 3 PSMAfore Trial in Metastatic Castration-Resistant Prostate Cancer - Karim Fizazi
Phase III PSMAfore Trial: Final Survival and Safety Data in mCRPC, Journal Club - Rashid Sayyid & Zachary Klaassen
PSMAfore Trial: Lutetium PSMA's Impact on mCRPC Quality of Life - Karim Fizazi
Innovative Prostate Cancer Therapy Insights Unveiled in ESMO 2023 Meeting - Alan Bryce
PSMAfore Study Unveils Game-Changing Results for Prostate Cancer Treatment - Oliver Sartor
Exploring the Latest Advances in Advanced Prostate Cancer Treatment - Oliver Sartor
PSMAfore Trial - Evaluating 177Lu-PSMA-617 in Chemotherapy-Naïve mCRPC Patients – Michael Morris
Prostate Cancer Working Group 4 Addresses PSMA PET as a Clinical Trial Endpoint - Michael Morris
Working Group 4 Introduces Updated Terminology for Advanced Prostate Cancer - Andrew Armstrong
Integrating Lutetium-177-PSMA-617: Sequencing, Combinations, and Safety in Taxane-Naïve mCRPC - Michael Morris
Implementing Radioligand Therapy in a Urology Practice: A Discussion of Practical, Regulatory, and Team Considerations - Neal Shore
Implementing Lutetium-PSMA — From Trial Design to Operations - Oliver Sartor
Integrating PSMA PET Imaging: From Interpretation to Systemic Therapy Selection in Castration-Resistant Prostate Cancer - Oliver Sartor
Lutetium-177 PSMA Radioligand Therapy Advances to Earlier mCRPC Setting - Daniel Petrylak & Steven Finkelstein
Health-Related Quality Outcomes for Pre-Chemotherapy mCRPC Treatment - Neal Shore
Selecting Therapy in Metastatic Hormone-Sensitive Prostate Cancer: A Multi-Step Approach - Pedro Barata
How Clinicians Navigate Multidisciplinary Care for Metastatic Hormone-Sensitive Prostate Cancer - Jacqueline Brown
Individualized Goals and Shared Decision-Making in mHSPC Care - Daniel George
Quality of Life and Treatment Intensification in mHSPC - Fred Saad
How Patient Function and Independence Are Changing Advanced Prostate Cancer Care - Kristine Lacuna
Considerations for Managing Patients as They Progress to Castration-Resistant Prostate Cancer - Tian Zhang
Multidisciplinary Strategies for Managing the Complexities of mHSPC Care - Neal Shore

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Physician-Scientist Review Articles
State of the Evidence Review Articles
Written by Rashid K. Sayyid, MD, MSc, and Zachary Klaassen, MD, MSc
March 21, 2023
Neoadjuvant cisplatin-based chemotherapy combinations have demonstrated five-year overall survival benefits of around 5%5 and pathologic complete responses rates of 36 to 42% with contemporary chemotherapy regimens.6
Written by Rashid K. Sayyid, MD, MSc, and Zachary Klaassen, MD, MSc
March 21, 2023
Early treatment intensification with neoadjuvant cisplatin-based chemotherapy has long been advocated as means to improve survival outcomes in patients with clinically localized, muscle invasive disease undergoing definitive local therapy.
Written by Rashid K. Sayyid, MD, MSc, and Zachary Klaassen, MD, MSc
March 20, 2023
While neoadjuvant cisplatin-based chemotherapy combinations have demonstrated five-year overall survival benefits of at least 5%,5 a significant proportion of patients remain “cisplatin ineligible”, defined by at least one of the following criteria.
Written by Rashid K. Sayyid, MD, MSc, and Zachary Klaassen, MD, MSc
March 20, 2023
While the majority of patients are diagnosed with non-muscle invasive disease (i.e. carcinoma in situ, Ta, and T1), approximately 25 to 33% of patients are initially diagnosed with muscle invasive bladder cancer and a meaningful proportion of patients initially diagnosed with non-muscle invasive disease will subsequently progress to MIBC.1
Written by Marco Bandini, and Andrea Necchi
August 13, 2020
Over the last few years, the landscape of bladder cancer (BC) management has profoundly changed, thanks to increased knowledge of disease biology and the identification of novel therapeutic approaches and biomarkers.1 No more than 5 years ago, the treatment-decision process for non muscle-invasive BC (NMIBC) or muscle-invasive BC (MIBC) was represented by radical surgery in most cases, with an opportunity for perioperative systemic therapy in a few cases. To date, the diagnostic and therapeutic armamentarium has been exceedingly enlarged for these patients.

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Physician-Scientist Commentaries
Peer-reviewed Abstract Supplemental Commentaries
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
The accurate diagnosis of histological subtypes in bladder cancer remains challenging with significant interobserver variability, yet proper identification is critical for optimal clinical management. A recent study analyzed the temporal trends in the diagnosis of bladder cancer histological subtypes in the United States
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Surrogates for overall survival can expedite the development of adjuvant treatments for bladder cancer, yet careful data-driven validation of these endpoints is needed. A recent study evaluated whether disease-free survival (DFS) or distant metastasis-free survival (DMFS) are valid surrogates for overall survival (OS) in patients with muscle-invasive bladder cancer
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Muscle-invasive bladder cancer (MIBC) requires multimodal treatment consisting of neoadjuvant chemotherapy followed by radical cystectomy. The NIAGARA trial recently established the benefit of adding perioperative immunotherapy with durvalumab to standard gemcitabine/cisplatin chemotherapy in MIBC.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Muscle-invasive urothelial carcinoma is associated with high recurrence rates despite standard radical surgery, with over 50% of patients experiencing disease recurrence within 2-3 years. A recent retrospective cohort study examined real-world effectiveness of adjuvant nivolumab, which received FDA approval based on the CheckMate 274 trial.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Trimodal therapy (TMT) as an alternative to radical cystectomy (RC) for muscle-invasive bladder cancer (MIBC), with recent retrospective analyses showing similar oncologic outcomes. However, comparative cost-effectiveness data are lacking. A recent study compares the cost-effectiveness of TMT versus RC from a Medicare perspective.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Muscle-invasive bladder cancer (MIBC) with hydronephrosis typically warrants radical cystectomy, though the impact of chemoradiotherapy (CRT) on hydronephrosis remains unclear. A recent study evaluated the incidence, etiology, and management of hydronephrosis before and following CRT in patients with MIBC.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Muscle-invasive bladder cancer (MIBC) is characterized by a complex tumor microenvironment that drives aggressive progression and treatment resistance; however, the key players in the microenvironment and their interactions are not well understood.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Radical cystectomy (RC) is the standard treatment for patients with Muscle-invasive bladder cancer (MIBC). However, it carries significant morbidity, perioperative mortality of about 5%, and negative impacts on quality of life. A recent phase 2 trial evaluated the efficacy and safety of neoadjuvant sintilimab (a PD-1 inhibitor) combined with gemcitabine
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
More effective neoadjuvant treatments are needed for patients with muscle-invasive bladder cancer (MIBC). A recent phase II clinical trial evaluated the combination of anti-PDL1 inhibitor durvalumab and PARP inhibitor olaparib as neoadjuvant therapy, focusing on molecular dynamics in pre-treatment and post-treatment settings.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Localized Muscle-invasive bladder cancer (MIBC) requires definitive treatment with curative intent. A recent systematic review and meta-analysis by Fong et al. compared survival outcomes between radical cystectomy (RC) and trimodality therapy (TMT) in patients with MIBC. The investigators conducted a literature search across PubMed, Embase, Scopus, and CENTRAL databases
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Neoadjuvant chemotherapy prior to radical cystectomy is a standard of care in patients with muscle-invasive bladder cancer. A retrospective multicenter study examined the contributions of preoperative clinical disease stage and chemotherapy to clinical outcomes. The investigators analyzed 513 patients who underwent RC for cT2-4N0-3M0 bladder cancer between 2010 and 2017.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Muscle-invasive urothelial cancer (MIUC) has a high recurrence risk following definitive treatment. A recent phase II single-arm trial evaluated nivolumab as adjuvant therapy following chemoradiation in patients with localized or locoregional urothelial carcinoma who were ineligible for or declined radical surgery.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Radical cystectomy is an effective treatment option for high-risk, non-muscle-invasive bladder cancer (NMIBC) to prevent progression. A recent 12-year multicenter study evaluated survival outcomes of patients with NMIBC who underwent robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD).
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Neoadjuvant chemo-immuno therapy followed by radical cystectomy is the standard of care for patients with muscle-invasive bladder cancer (MIBC). However, up to 40% of patients are ineligible to receive Cisplatin-based chemotherapy. In a single-arm phase 1b trial, Li et al. investigated the safety and efficacy of combining
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Patients with prostate cancer are at increased risk of developing radiation-induced secondary bladder cancer (RT-BC) due to external radiation therapy (EBRT) or brachytherapy (BT) for prostate cancer. However, there is a lack of data regarding survival differences after radical cystectomy (RC) between radiotherapy-exposed versus radiotherapy-unexposed patients with BC.
Written by Daniele Raggi, MD, & Prof. Robert A. Huddart, PhD
The phase 3 NIAGARA trial has introduced promising advancements in the treatment landscape for muscle-invasive bladder cancer (MIBC). By integrating perioperative durvalumab with neoadjuvant cisplatin-based chemotherapy, the study demonstrated statistically significant improvements in event-free survival (EFS) and overall survival (OS) compared to neoadjuvant chemotherapy alone. This pivotal finding positions the combination as a potential new standard of care for cisplatin-eligible MIBC patients.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Up to 40% of patients with Muscle-invasive bladder cancer (MIBC) are ineligible for cisplatin-based neoadjuvant therapy or radical surgery due to comorbidities. Carriere et al. investigated the effects of bladder-preserving radiotherapy in LA-MIBC patients who are ineligible for or refuse radical cystectomy (RC).
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
The standard treatment for localized bladder cancer (BC) is neoadjuvant chemotherapy with cisplatin followed by radical cystectomy (RC), but this poses challenges for older patients due to high post-operative complications. An alternative approach, trimodal therapy (TMT), aims to preserve bladder function in selected patients.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
A current standard of care treatment for muscle-invasive bladder cancer (MIBC) is platinum-based neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC). Bladder-sparing protocols are available for patients who cannot or prefer not to receive surgery and include maximal transurethral resection of the bladder (TURBT)
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Transurethral resection of bladder tumor (TURBT) is a diagnostic and staging tool for muscle-invasive bladder cancer (MIBC). However, staging may not be precise due to technical limitations. Distinguishing non-muscle invasive bladder cancer (NMIBC) from MIBC at an earlier time can expedite treatment selection and potentially enhance survival outcomes. James et al. 
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Neoadjuvant chemotherapy followed by radical cystectomy (RC) is a standard of care for patients with muscle-invasive bladder cancer (MIBC). Adjuvant treatment is recommended for patients with a high-risk of relapse. Biomarkers like circulating tumor DNA (ctDNA) could potentially predict relapse and guide adjuvant therapy.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Resistance to platinum-based chemotherapy is a significant concern in patients undergoing treatment for bladder cancer. A recent study, Jones et al. investigated the mechanisms driving chemoresistance, with the goal of discovering potential targets to improve treatment response.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
The plasmacytoid variant of bladder cancer (PV-BCa) is an aggressive subtype with a low 5-year survival rate. Mutations that lead to truncation of CDH1 are central to the pathology of PV-BCa and lead to loss of E-cadherin expression, which in turn allows the invasive spread of tumor cells.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
The standard treatment for muscle-invasive bladder cancer (MIBC) is radical cystectomy (RC) with neoadjuvant chemotherapy (NAC). Although NAC is associated with a 5-10% increase in overall survival (OS) compared to RC alone, it is underutilized. The European Association of Urology recommends RC
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
The presence of circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) is indicative of relapse and worsening prognosis. Due to the practical barriers to sequencing tumor samples for ctDNA measurement, medical researchers have focused efforts on developing alternative assays.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Robot-assisted RC (RARC) procedures are popular due to faster recovery times. A recent study by Khetrapal et al. performed a systematic review and meta-analysis of randomized controlled trials (RCTs) – of outcomes in patients with bladder cancer who underwent RARC versus open RC (ORC). A total of seventeen studies were included in the analysis, which encompassed eight RCTs and 1,024 patients. 509 patents underwent ORC
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
In patients with bladder cancer (BC), neoadjuvant chemotherapy after radical cystectomy (RC) has been found to enhance survival and is therefore considered a gold standard for treatment. Li et al. investigated long-term outcomes among BC patients who underwent RC with or without perioperative chemotherapy. A total of 1,700 patients were included in the study, among whom 805 underwent RC without any perioperative chemotherapy (NC)
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Neuroendocrine carcinoma of the urinary tract (NEC-URO) is a rare and aggressive variant of urothelial carcinoma (UC). There has been limited data on the optimal management for NEC-URO. Accordingly, Alhalabi et al. previously conducted a phase 2 study in which patients with NEC-URO received an alternating doublet treatment of chemotherapy with ifosfamide plus doxorubicin (IA) and etoposide plus cisplatin (EP).
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
The standard of care for muscle-invasive bladder cancer (MIBC) is cisplatin-based neoadjuvant chemotherapy followed by radical cystectomy. Studies have documented the clinical benefit of dose-dense methotrexate-vinblastine-adriamycin-cisplatin (ddMVAC) or gemcitabine plus cisplatin (GC). The COXEN approach was developed to use gene expression 
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
A standard of care treatment for patients with muscle-invasive bladder cancer (MIBC) is cisplatin-based neoadjuvant chemotherapy (NAC) followed by radical cystectomy. Since this treatment modality is associated with significant toxicity, predicting patient response to treatment can prevent unnecessary adverse events and delays to effective treatment.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Patients with muscle-invasive bladder cancer (MIBC) typically receive cisplatin-based chemotherapy prior to radical cystectomy. However, around half of MIBC patients may be ineligible for cisplatin, therefore necessitating alternative treatment modalities.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
The molecular subtyping of muscle-invasive bladder cancer (MIBC) cases in recent years provided a framework for understanding the biology of the disease. There is a knowledge gap regarding whether specific molecular subtypes are driven by genetic alterations that can impact the underlying pathology.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
Node-positive bladder cancer is a transitional step in the metastatic cascade between localized and metastatic disease. Wagner et al. examined the radiographical and pathological lymph node status as an independent predictor for survival following neoadjuvant gemcitabine and cisplatin in patients
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine
For patients with muscle-invasive bladder cancer (MIBC), the gold standard for treatment is cisplatin-based neoadjuvant chemotherapy followed by radical cystectomy. However, the response to neoadjuvant chemotherapy varies significantly, and additional regimens that enhance
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Patients with intermediate-risk non-muscle invasive bladder cancer (NMIBC) frequently require adjuvant therapy. The HIVEC-II study is a multi-center randomized controlled trial (RCT) that compared clinical outcomes of intermediate-risk NMIBC patients receiving hyperthermia and mitomycin C versus mitomycin C alone.
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Combining real-world data and electronic health records for biomarker discovery can inform future clinical trial designs. This is important given that most randomized controlled trials do not always investigate clinical biomarkers along with the tested drug. A recent study by Szabados et al.
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
There is a well-documented increase in the risk of cancer development after a kidney transplant. For example, Lim et al. recently published a whole-exome sequencing analysis of somatic mutations in patients who underwent kidney transplants and subsequently developed urothelial carcinoma.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine, New York City, New York
The use of cisplatin-based neoadjuvant chemotherapy has been shown to improve survival in muscle-invasive bladder cancer patients undergoing radical cystectomy. Benidir et al. aimed to investigate differences in pathologic and survival outcomes
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine, New York City, New York
Primary bladder malignancy accounts for up to 95% of urothelial carcinomas (UC), and upper tract urothelial carcinoma (UTUC) accounts for the rest of UC cases. Radical cystectomy (RC) is the typical treatment for aggressive UC, while radical nephroureterectomy (RNU) is the treatment of choice for aggressive UTUC.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine, New York City, New York
The role of adjuvant therapy in muscle-invasive urothelial carcinoma is unclear, despite the high risk of metastatic recurrence. Adjuvant cisplatin-based chemotherapy is challenging to administer, and some patients are ineligible for or decline neoadjuvant cisplatin-based chemotherapy.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine, New York City, New York
Incorporating neoadjuvant chemotherapy (NAC) into the management of patients with localized muscle-invasive bladder cancer (MIBC) improves survival. However, due to multiple factors, NAC is still not effectively used in real-life settings.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine, New York City, New York
Muscle-invasive bladder cancer (MIBC) is associated with a high risk of developing pelvic recurrence. Although adjuvant external beam radiotherapy (EBRT) decreases the risk of local recurrence, it has been associated with severe toxicity.
Written by Bishoy M. Faltas
Englander Institute for Precision Medicine, Weill Cornell Medicine, New York City, New York
Non-muscle invasive bladder cancer (NMIBC) has one of the highest local recurrence rates of any malignancy. The current standards of care for NMIBC surveillance are white light cystoscopy and urine cytology.
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Immune checkpoint inhibitors (ICIs) have transformed the treatment paradigm in muscle-invasive bladder cancer (MIBC). However, not all patients have consistent responses to these agents, and predictive biomarkers are still needed.
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Cisplatin-based chemotherapy is the standard-of-care neoadjuvant treatment for patients with muscle-invasive bladder cancer (MIBC). Taxanes were evaluated previously combined with cisplatin in the neoadjuvant setting. However, it is unclear if cabazitaxel, a novel taxane, synergizes with cisplatin.
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Neoadjuvant cisplatin-based chemotherapy in patients with muscle-invasive bladder cancer (MIBC) before radical cystectomy improves overall survival. Commonly used neoadjuvant chemotherapy regimens include the combination of dose-dense methotrexate
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Non-muscle-invasive bladder cancers (NMIBC) represent a heterogeneous group of tumors with variable clinical outcomes. Multiple risk features are incorporated in predicting the risk of recurrence and progression to muscle-invasive bladder cancer (MIBC).
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Radiation therapy is commonly used for the definitive and palliative treatment of pelvic malignancies. Secondary pelvic cancers have been reported after radiation therapy, including radiation-associated muscle-invasive bladder cancer (RA-MIBC).
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Non-muscle invasive bladder cancers (NMIBC) constitute the majority of bladder cancer diagnoses. NMIBCs are stratified based on the risk of progression to muscle-invasive disease into low, intermediate, and high-risk groups.
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Gene expression profiling has successfully classified muscle-invasive bladder cancer (MIBC) tumors into distinct categories that differ in their genetic characteristics and tumor mutation burden (TMB). In addition to cancer-cell autonomous factors,
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
A few bladder-sparing treatment options are available for BCG-unresponsive patients, including valrubicin and the recently FDA-approved pembrolizumab. However, additional treatment options that achieve a durable response are needed.
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
There is a need for accurate nomograms for predicting oncological outcomes in intermediate-risk non–muscle-invasive bladder cancer (NMIBC) patients. Such accurate tools can be used to guide decision
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Nivolumab is an FDA-approved immune checkpoint for treating platinum-resistant metastatic or surgically unresectable urothelial carcinoma (mUC). The development of predictive biomarkers
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Radical cystectomy continues to be the mainstay curative modality for bladder cancer patients. Understanding the long-term clinical outcomes of robotic and open radical cystectomy is critical for decision making.
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Effective intravesical postoperative chemotherapy can reduce the risk of bladder cancer recurrence. A recent study by Fukuokaya et al. published in Clinical Genitourinary Cancer examined
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
The optimal management of non-muscle invasive bladder cancer (NMIBC), some histologic variants, including squamous and glandular, is challenging. A recent article published by Suh et al. in Scientific Reports compared Bacillus Calmette-Guérin
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Understanding the demographic factors which affect clinical outcomes following radical cystectomy (RC) is critical for improving oncologic outcomes for all patients. A recent study published in European Urology Oncology examined intraoperative
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Treatment options available for intermediate or high-risk non-muscle invasive bladder cancer include intravesical Bacillus Calmette-Guerin (BCG) and radical cystectomy.
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
The relationship between the expression of GATA3, cytokeratin (CK) 20, CK 5/6, and p53 and survival in patients with muscle-invasive bladder cancer (MIBC) is not well characterized.
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Bacillus Calmette-Guerin shortage is a critical access issue for patients with non-muscle-invasive bladder cancer (NMIBC). Defining the efficacy of alternative intravesical treatments is an active area of investigation.
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Patients who achieved a pathologic complete response (pCR) after neoadjuvant chemotherapy (NAC) have a better prognosis compared to patients with pathologic residual disease (pRD).
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Neoadjuvant chemotherapy followed by radical cystectomy (RC) with lymph node dissection is the standard of care in patients with muscle-invasive urothelial bladder carcinoma (MIBC).
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Patients with muscle-invasive bladder cancer  (MIBC) who are treated with neoadjuvant chemotherapy (NAC) before cystectomy have a survival advantage.
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Radical cystectomy (RC) is currently the gold standard operative treatment for localized (T2-T4a) muscle-invasive bladder cancer (MIBC) or recurrent high-risk non-MIBC.
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Downstaging of muscle-invasive bladder cancer (MIBC) following neoadjuvant chemotherapy (NAC) before radical cystectomy (RC) has been correlated with higher survival rates.  
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Neoadjuvant chemotherapy is a standard of care for patients with cisplatin-eligible muscle-invasive urothelial carcinoma.
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Neoadjuvant chemotherapy is a standard of care for patients with urothelial muscle-invasive bladder cancer.
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Methotrexate-vinblastine-doxorubicin-cisplatin (MVAC) neoadjuvant chemotherapy is a standard of care for muscle-invasive urothelial bladder cancer.
Written by Bishoy M. Faltas, MD
Englander Institute for Precision Medicine, Weill Cornell Medicine
Neoadjuvant chemotherapy is a standard of care for muscle-invasive bladder cancer (MIBC).

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Conference Coverage
Conference Highlights Written by Physician Scientists
Presented by Nicholas James, MBBS, PhD
The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting was host to a session on new approaches to curing bladder and kidney cancer. Dr. Nicholas James presented the feasibility and safety results from RAD-IO, a multi-stage trial of durvalumab plus chemoradiotherapy with 5-FU and mitomycin C in patients with muscle invasive bladder cancer (MIBC).
Presented by Yijun Shen, MD
The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting was host to a kidney and bladder cancers oral abstract session. Dr. Yijun Shen presented the results of a phase 2/3 trial evaluating perioperative SHR-A2102, a novel nectin-4-targeted antibody-drug conjugate (ADC), in combination with adebrelimab for patients with muscle invasive bladder cancer (MIBC).
Presented by Richard Cathomas, MD
The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting was host to a kidney and bladder cancers oral abstract session. Dr. Richard Cathomas presented the primary analysis of SAKK 06/19 evaluating intravesical recombinant BCG combined with chemotherapy + immunotherapy (chemi0IO) as perioperative therapy for patients with muscle invasive bladder cancer (MIBC).
Presented by Elaine Lam, MD
In a presentation titled, “How to Assess Response After Perioperative Enfortumab Vedotin and Pembrolizumab in MIBC,” Dr. Elaine Lam reviewed the rapidly evolving evidence supporting perioperative enfortumab vedotin plus pembrolizumab (EV+P), discussed how to define and measure clinical complete response (cCR), and outlined the key unanswered questions that will shape next-generation bladder-sparing clinical trials.
Presented by Zhuo Su, MD
The 2026 AUA annual meeting featured an invasive bladder cancer session and a presentation by Dr. Zhuo Su discussing a cost-effectiveness analysis of competing treatment strategies for cisplatin-eligible muscle invasive bladder cancer in the era of immune checkpoint inhibitors.
Presented by Alexandre R. Zlotta, MD, PhD, FRCSC
The 2026 European Association of Urology (EAU) Annual Meeting held in London, U.K., was host to the Urothelial Cancer: Towards Integrated Therapeutic Strategies plenary session. Dr. Alexandre Zlotta delivered the state-of-the-art lecture Who Really Needs Surgery after Neo-adjuvant Chemotherapy?
Presented by Jørgen Bjerggaard Jensen, MD
The 2026 European Association of Urology (EAU) Annual Meeting held in London, U.K., was host to the Urothelial Cancer: Towards Integrated Therapeutic Strategies plenary session. Dr. Jørgen Bjerggaard Jensen, in the Beyond the Muscle debate session on Redefining MIBC management, discussed the pros of ctDNA and how it should guide adjuvant decisions.
Presented by Jeremy Teoh, MBBS, FRCSEd (Urol), FCSHK, FHKAM (Surgery)
The 2026 European Association of Urology (EAU) Annual Meeting held in London, U.K., between March 13th and 16th 2026, was host to the Urothelial Cancer: Towards Integrated Therapeutic Strategies plenary session. Dr. Jeremy Teoh presented the state-of-the-art lecture, Bladder-sparing in MIBC: The Real-world Evidence.
Presented by Matthew Galsky, MD
The European Association of Urology (EAU) 2026 Annual Congress was host to the “Common Problems and Controversies in Bladder Cancer: Rapid-Fire Debates” session, developed and led by Dr. Ashish Kamat. Dr. Matthew Galsky presented a case study, following which Drs. Thomas Powles and Patrizia Giannatempo debated whether all muscle-invasive bladder cancer (MIBC) patients planned for a radical cystectomy should receive peri-operative immune-oncology (IO)-based therapy or neoadjuvant chemotherapy (NAC) followed by risk-adapted adjuvant IO therapy.
Presented by Pooja Ghatalia, MD
The 2026 GU ASCO annual meeting featured a urothelial carcinoma session and a presentation by Dr. Pooja Ghatalia discussing an integrated analysis of the RETAIN trials assessing ctDNA to guide response-adapted bladder preservation in muscle-invasive bladder cancer.
Presented by Matthew D. Galsky, MD
The 2026 GU ASCO annual meeting featured a urothelial carcinoma session and a presentation by Dr. Matthew Galsky discussing results from the randomized, open-label, phase 3 KEYNOTE-B15 study assessing neoadjuvant and adjuvant enfortumab vedotin + pembrolizumab for participants with muscle invasive bladder cancer who are eligible for cisplatin.
Presented by Yair Lotan, MD
The 2025 SUO annual meeting featured a urothelial carcinoma session and a presentation by Dr. Yair Lotan discussing the prognostic performance of a computational histology artificial intelligence (CHAI) biomarker in muscle-invasive bladder cancer.
Presented by Christof Vulsteke, MD, PhD
The 2025 European Society of Medical Oncology (ESMO) Annual Congress held in Berlin, Germany between September 17th and 21st was host to the session Presidential Symposium 1. Dr. Christof Vulsteke presented the LBA2 - Perioperative (enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase 3 KEYNOTE-905 study.
Presented by Nataliya Mar, MD
The 2025 European Society for Medical Oncology (ESMO) Annual Congress held in Berlin, Germany, was host to a urothelial carcinoma poster session. Dr. Nataliya Mar presented the results of an exploratory analysis of the EV-302 trial of enfortumab vedotin + pembrolizumab (EV+P) in older patients with previously untreated locally advanced or metastatic urothelial carcinoma.
Presented by Andrea Necchi, MD
The 2025 ESMO annual meeting featured a urothelial carcinoma mini oral session and a presentation by Dr. Andrea Necchi discussing the SunRISe-4 primary analysis and biomarker results assessing neoadjuvant TAR-200 + cetrelimab or cetrelimab alone in patients with muscle-invasive bladder cancer. The standard of care for muscle-invasive bladder cancer (T2-T4aN0M0) is radical cystectomy + neoadjuvant chemotherapy, or chemoradiation for select patients.
Presented by Nicholas D. James, MBBS, PhD
 The 2025 ESMO annual meeting featured a urothelial carcinoma mini oral session and a presentation by Dr. Nicholas D. James discussing final survival analysis results from the BladderPath trial assessing upfront MRI versus transurethral resection for staging new bladder cancers. TURBT has been the mainstay of bladder cancer staging for more than 60 years.
Presented by Andrea Necchi, MD
The 2025 ESMO annual meeting featured a urothelial carcinoma proffered paper session and a presentation by Dr. Andrea Necchi discussing primary results of the GDFather-NEO trial, a blinded, exploratory phase 2 trial of nivolumab and the GDF-15 neutralizing antibody visugromab or placebo as neoadjuvant treatment of patients with muscle-invasive bladder cancer. Approximately 50% of patients with muscle invasive bladder cancer
Presented by Michiel S. Van der Heijden, MD, PhD
The 2025 ESMO annual meeting featured a urothelial carcinoma mini oral session and a presentation by Dr. Michiel Van der Heijden discussing health related quality of life outcomes from the NIAGARA trial of perioperative durvalumab + neoadjuvant chemotherapy in muscle invasive bladder cancer. In the phase 3 NIAGARA trial,1 patients with muscle invasive bladder cancer treated with perioperative durvalumab
Presented by Matthew D. Galsky, MD
The 2025 ESMO annual meeting featured a urothelial carcinoma proffered paper session and a presentation by Dr. Matthew Galsky discussing 5-year efficacy and ctDNA results from CheckMate 274 assessing adjuvant nivolumab versus placebo for high-risk muscle invasive urothelial carcinoma. Despite standard of care, radical cystectomy with or without neoadjuvant cisplatin-based chemotherapy, a significant number of patients with muscle invasive urothelial carcinoma
Presented by Jens Bedke, MD
Jens Bedke, MD, presented Poster 4571: EV-302: Long-term subgroup analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).
Presented by Shilpa Gupta, MD
The 2025 ASCO annual meeting featured a urothelial carcinoma oral abstract session and a presentation by Dr. Shilpa Gupta discussing an exploratory analysis of responders from the phase 3 EV-302 trial of enfortumab vedotin + pembrolizumab versus chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma.
Presented by Thomas Powles, MD
The 2025 ASCO annual meeting featured a urothelial carcinoma oral abstract session and a presentation by Dr. Thomas Powles discussing circulating tumor DNA in patients with muscle invasive bladder cancer who received perioperative durvalumab in NIAGARA.
Presented by Philippe Spiess, BS, MS, MD, FRCS, FACS
The 2025 European Association of Urology (EAU) Annual Meeting held in Madrid, Spain between March 21st and 24th 2025, was host to the Biomarkers to guide peri-operative management in Uro-oncology Plenary Session. Dr. Philippe Spiess delivered a presentation discussing the role of Perioperative Neoadjuvant/Adjuvant Therapy in the Management of Bladder and Kidney Cancer.
Presented by Marco Moschini
The 2025 EAU annual meeting featured a rapid-fire debate session on common problems and controversies in bladder cancer and a presentation by Dr. Marco Moschini contending that for muscle invasive bladder cancer, only a diagnostic
Presented by Fredrik Liedberg, MD
The 2025 EAU annual meeting featured a rapid-fire debate session on common problems and controversies in bladder cancer and a presentation by Dr. Fredrik Liedberg contending that for muscle invasive bladder cancer, a maximal TURBT is needed.
Presented by Thomas Powles, MBBS, MRCP, MD
The 2025 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Annual Symposium held in San Francisco, CA between February 13–15, 2025 was host to a urothelial carcinoma rapid oral abstract session. Dr. Thomas Powles presented an updated analysis from the phase III global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).
Presented by Scot A. Niglio, MD
The 2025 GU ASCO annual meeting featured a urothelial carcinoma session and a discussant presentation by Dr. Scot Niglio discussing two abstracts: “Safety and efficacy of neoadjuvant immunotherapy with durvalumab in combination with neoadjuvant chemotherapy (gemcitabine/cisplatin or carboplatin) in patients with operable high-risk upper tract urothelial carcinoma” by Dr. Nadine Houede, and “Neoadjuvant treatment with disitamab vedotin plus perioperative toripalimab in patients with muscle-invasive bladder cancer with HER2 expression: Updated efficacy and safety results from the phase II RC48-C017 trial” by Dr. Xinan Sheng.
Presented by Elizabeth R. Plimack, MD
The 2025 GU ASCO annual meeting featured a urothelial carcinoma session and a discussant presentation by Dr. Elizabeth Plimack discussing two abstracts: “Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: Additional efficacy outcomes including overall survival in patients with muscle-invasive bladder cancer from CheckMate 274” by Dr. Matthew Milowsky, and “Additional efficacy and safety outcomes and an exploratory analysis of the impact of pathological complete response on long-term outcomes from NIAGARA” by Dr. Matthew Galsky.
Presented by Matthew I. Milowsky, MD, FASCO
The 2025 GU ASCO annual meeting featured a urothelial carcinoma session and a presentation by Dr. Matthew Milowsky discussing additional efficacy outcomes in patients with muscle-invasive bladder cancer from CheckMate 274 assessing adjuvant nivolumab versus placebo.
Presented by Matthew D. Galsky, MD
The 2025 GU ASCO annual meeting featured a urothelial carcinoma session and a presentation by Dr. Matthew Galsky discussing additional efficacy and safety outcomes and an exploratory analysis of the impact of pathological complete response on long-term outcomes from NIAGARA.
Presented by Leslie Ballas, MD, FASTRO
The 2024 ASTRO annual meeting was host to the session Presidential Symposium: Innovations in Genitourinary Cancers: Session II - Bladder Preservation - A Modern Choice for Patients. Dr. Leslie Ballas opened this session with a talk titled: Bladder Preservation - A Modern Choice for Patients.
Presented by Aymeric Zadoroznyj, MD
The 2024 IBCN annual meeting included a session on treatment response correlates, featuring a presentation by Dr. Aymeric Zadoroznyj discussing the systematic evaluation of differentially expressed genes associated with response to neoadjuvant chemotherapy in muscle invasive bladder cancer. Neoadjuvant cisplatin-based combination chemotherapy is standard of care for patients with muscle-invasive bladder cancer.
Presented by Jacqueline Fontugne, MD
The 2024 IBCN annual meeting included a session on treatment response correlates, featuring a presentation by Dr. Jacqueline Fontugne discussing quantification of intra-tumoral molecular subtype heterogeneity in muscle invasive bladder cancer from histological slides using a deep learning approach in the VESPER trial.
Presented by  Andrea Necchi, MD
The 2024 IBCN annual meeting included a session on novel therapies and outcome measures in clinical trials, featuring a presentation by Dr. Andrea Necchi discussing the interim analysis of SunRISe-4, assessing TAR-200 + cetrelimab or cetrilumab alone as neoadjuvant therapy in patients with muscle-invasive bladder cancer.
Presented by Brigida Maiorano, MD
The 2024 IBCN annual meeting included a session on advancements in circulating biomarkers, featuring a presentation by Dr. Brigida Maiorano discussing the biomarker analysis from the Nure-COMBO trial assessing neoadjuvant nivolumab + nab-paclitaxel in muscle invasive bladder cancer.
Presented by Kent Mouw, MD, PhD
The 2024 IBCN annual meeting included a session on advancements in circulating biomarkers, featuring a presentation by Dr. Kent Mouw discussing the correlation of ctDNA dynamics with clinical response in muscle-invasive bladder cancer patients undergoing trimodality therapy.
Presented by Lourdes Mengual, PhD
The 2024 IBCN annual meeting included a session on advancements in circulating biomarkers, featuring a presentation by Dr. Lourdes Mengual discussing dynamic monitoring of circulating tumor DNA (ctDNA) to predict prognosis in muscle-invasive bladder cancer patients after radical cystectomy.
Presented by Jørgen Bjerggaard Jensen, MD
The 2024 ESMO Annual Congress was host to a proffered paper session for non-prostate genitourinary malignancies. Dr. Jørgen Bjerggaard Jensen presented the preliminary results from the TOMBOLA trial, which evaluated whether serial circulating tumour DNA (ctDNA) testing could be used to identify bladder cancer patients that could benefit from early post-cystectomy immunotherapy.
Presented by Petros Grivas MD, PhD
The 2024 ESMO was host to the session Presidential Symposium and Dr. Petros Grivas discussed the presentation by Dr. Thomas B. Powles who presented the results of the NIAGARA trial, a randomized phase 3 trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer.
Presented by Thomas B. Powles, MBBS, MRCP, MD
The 2024 ESMO Annual Congress was host to the session Presidential Symposium II: Practice-changing trials. Dr. Thomas B. Powles presented the results of the NIAGARA trial, the first randomized phase 3 trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer.
Presented by Thomas B. Powles, MBBS, MRCP, MD
(UroToday.com) The 2024 European Society of Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain was host to the session Mini oral session: GU tumours, non-prostate. Dr. Thomas B. Powles presented an exploratory analysis of Nectin-4 Expression and Response to first line Enfortumab Vedotin (EV) + Pembrolizumab (P) in previously Untreated patients with locally advanced or metastatic urothelial cancer (UC).
Presented by Maria De Santis, MD, PhD

At the 2024 ESMO annual meeting, Dr. Maria De Santis discussed three key urothelial carcinoma abstracts: updated SunRISe-1 results on TAR-200 +/- cetrelimab in BCG-unresponsive high-risk NMIBC, the AMBASSADOR study on adjuvant pembrolizumab in muscle-invasive urothelial carcinoma, and ctDNA clearance in cisplatin-ineligible MIBC from the VOLGA trial.

Presented by Andrea Apolo
(UroToday.com) The 2024 ESMO annual meeting included a session on urothelial carcinoma, featuring a presentation by Dr. Andrea Apolo, discussing extended follow-up for disease free survival and an assessment of metastatic disease recurrence pattern from the AMBASSADOR study of adjuvant pembrolizumab
Presented by Jens Bedke, MD
The 2024 ASCO annual meeting was host to a presentation by Dr. Jens Bedke who presented their poster titled: Enfortumab vedotin (EV) with pembrolizumab (P) versus chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): Analysis of cisplatin (cis)-eligible population from EV-302/KEYNOTE-A39.
Presented by Michiel Simon Van Der Heijden, MD, PhD
 The 2024 ASCO annual meeting was host to a presentation by Dr. Michiel Simon Van Der Heijden presenting a secondary analysis of the cisplatin (cis)-ineligible population from EV-302/KEYNOTE-A39 comparing Enfortumab vedotin (EV) with pembrolizumab (P) versus chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).
Presented by Peter H. O'Donnell, MD
The 2024 ASCO annual meeting was host to a presentation by Dr. Peter H. O'Donnell, who presented the study EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients with muscle invasive bladder cancer (MIBC)—2-year event-free survival and safety data for Cohort H.
Presented by Andrea Necchi, MD
(UroToday.com) The 2024 European Association of Urology (EAU) annual meeting featured a plenary session on living with advanced kidney cancer and urothelial cancer, and a state of the art lecture by Dr. Andrea Necchi discussing whether there is a new standard treatment of metastatic bladder cancer based on EV-302/KEYNOTE-A39.
Presented by Andrea Necchi, MD, Peter Black, MD, Jørgen Bjerggaard Jensen, MD, DMSc
The 2024 European Association of Urology (EAU) annual congress held in Paris, France between April 5th and 8th was host to a plenary session addressing imaging-related controversies for the staging of genitourinary cancers. Professors Andrea Necchi, Peter Black, and Jørgen Bjerggaard participated in a rapid-fire debate discussing whether we can use circulating tumor DNA (ctDNA) and/or urine tumor DNA (utDNA) in patients with muscle-invasive bladder cancer (MIBC) following radical cystectomy to guide treatment decision on adjuvant therapy.
Presented by Valeria Panebianco, MD
The 2024 European Association of Urology (EAU) annual congress held in Paris, France between April 5th and 8th was host to a plenary session addressing imaging-related controversies for the staging of genitourinary cancers. Professor Valeria Panebianco discussed the Vesical Imaging-Reporting and Data System (VI-RADS) and its potential to replace/complement transurethral resection of bladder tumor (TURBT) for diagnosing bladder cancer.
Presented by Elizabeth R. Plimack, MD, MS
The 2023 ESMO Annual Congress held in Madrid, Spain between October 20th and 24th, 2023 was host to a bladder preservation strategies oral session. Dr. Elizabeth Plimack discussed the role of systemic therapy in bladder preservation for patients with muscle-invasive bladder cancer (MIBC).
Presented by Srikala Sridhar, MD, MSc, FRCSC
In this presentation, Dr. Srikala Sridhar gave a talk on the role of neoadjuvant immunotherapy (IO) for muscle-invasive bladder cancer (MIBC). As she notes off the bat, MIBC is a highly aggressive systemic disease with poor long-term outcomes. Neoadjuvant cisplatin-based chemotherapy (NAC) remains the standard of care
At the 2022 ASCO annual meeting, the poster discussion session that focused on Kidney and Bladder cancers included a presentation from Dr. Richard Cathomas discussing the role of peri-operative chemoimmunotherapy for patients undergoing radical cystectomy for muscle invasive urothelial carcinoma based on the SAKK 06/17 trial.
Presented by Alejandro Berlin, MD MSc
In the Latin America ASTRO session of the American Society for Radiation Oncology (ASTRO) Annual Congress, Dr. Berlin presented on controversies in the management of patients with Muscle-invasive bladder cancer (MIBC).
Presented by Nick Beije, MD, Ph.D and Morgan Roupret, MD, Ph.D
Dr. Nick Beije of Rotterdam, presented the final results of the CirGuidance Study, which focused on the use of the circulating tumor cells (CTCs) to drive neoadjuvant chemotherapy for muscle-invasive bladder cancer (MIBC). This was followed by a discussion and summary from Dr. Morgan Roupret.
Presented by Alex Kutikov, MD, FACS
The State of the Art lecture at the 2021 virtual annual meeting of the Southeastern Section of the AUA was provided by Dr. Alex Kutikov who discussed the current applications for radical cystectomy and perhaps to spare certain bladders while minimizing risk of disease progression.
Presented by Karen M. Wheeler, MD
Washington, DC (UroToday.com) As part of the Research Scholars Update at the 20th Annual Meeting of the Society of Urologic Oncology, Dr. Karen Wheeler presented her work on
Presented by Robert Huddart, MA, MBBS, MRCP, FRCR
Washington, DC (UroToday.com) Organ preservation in bladder cancer has been a widely debated topic with polarizing views from different centers and researchers worldwide.
Presented by Roland Seiler, PhD
Athens, Greece (UroToday.com) Dr. Roland Seiler presented after Dr. Andrea Necchi, supporting the role of chemotherapy in the neoadjuvant setting of treating muscle invasive bladder cancer
Presented by Kelly Stratton, MD
Athens, Greece (Urotoday.com) Neoadjuvant chemotherapy (NAC) in bladder cancer has been proven to improve overall survival in patients with muscle-invasive bladder cancer
Presented by Joep J. de Jong
Aarhus, Denmark (UroToday.com) Joep J. de Jong from the Erasmus MC Cancer Institute in Rotterdam discussed efforts at developing a genomic classifier to predict clinically
Presented by Yair Lotan, MD
San Francisco, CA (UroToday.com) Dr. Yair Lotan presented on Genomic Insights and Biomarkers for Treatment Selection in Muscle-Invasive and Non-Muscle-Invasive Bladder Cancer. He discussed the role of markers in bladder cancer and how they add independent information that can impact patient care.
Presented by Jeff Holzbeierlein, MD, FACS
San Francisco, CA (UroToday.com)  Dr. Holzbeierlein began his discussion on the new muscle-invasive bladder cancer (MIBC) guidelines,1 a collaborative multi-disciplinary effort led by Dr. Sam Chang that involved input from all the major organizations, including AUA, ASCO, ASTRO, and patient advocates.

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IBCG Newsletter Clinical Review Articles
State of the Evidence Review Articles
December 12, 2024
Bladder cancer is one of the most common cancers in the United States, impacting approximately 83,000 Americans each year. It is a disease that shocks not only the individuals diagnosed but also their families, caregivers, and communities. For healthcare providers, medical researchers, and doctors, bladder cancer deserves significant attention due to its prevalence and the urgent need for better treatments and outcomes.
Written by Amanda Myers, MD, Urologic Oncology Fellow, University of Texas, MD Anderson Cancer Center, Houston, TX
December 12, 2024
The IBCN 2024 occurred in Bern, Switzerland, from September 19th to September 21st, 2024. The event featured a keynote lecture on Friday morning by Niko Beerenwinkel, Professor of Computational Biology ETH Zurich, on “Inferring Tumor Evolution from Single-Cell Data.” Dr. Beerenwinkel discussed the evolutionary process of cancer, which can be visualized through tumor phylogeny and cell lineage trees.
Written by Kelly Bree, MD, and Niyati Lobo, MD
December 11, 2024
The annual International Bladder Cancer Group (IBCG) Retreat was held in Houston, Texas, from August 23-24, 2024. Co-chaired by Drs. Shilpa Gupta, Roger Li, and Patrick Hensley, the event brought together over 90 international bladder cancer clinicians, scientists, and patient advocates, with IBCG representation spanning five continents.
Written by Vignesh Packiam, MD, Associate Professor, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ
August 22, 2024
Sequential intravesical gemcitabine and docetaxel (Gem/Doce) has been a notable advancement in the treatment of non-muscle invasive bladder cancer (NMIBC) since Michael O’Donnell developed this regimen in 2009.1 Following its initial publication in 2015, Gem/Doce has continued to gain traction in the urologic oncology community for various challenging situations.
Publications
Peer-Reviewed Journal Abstracts
BACKGROUND: Muscle-invasive urothelial carcinoma is an aggressive disease with high rates of relapse. Whether pembrolizumab as adjuvant therapy would be effective in patients with high-risk muscle-invasive urothelial carcinoma after radical surgery is unknown.

Purpose Many patients with high-risk non-muscle-invasive bladder cancer (NMIBC) are either refractory to bacillus Calmette-Guerin (BCG) treatment or may experience disease relapse. We assessed the efficacy and safety of recombinant adenovirus interferon alfa with Syn3 (rAd-IFNα/Syn3), a replication-deficient recombinant adenovirus gene transfer vector, for patients with high-grade (HG) BCG-refractory or relapsed NMIBC.

We report pathologic, functional, and oncologic outcomes in patients treated with radical nephroureterectomy following radical cystectomy.

We identified patients who underwent radical cystectomy then radical nephroureterectomy for metachronous urothelial recurrence at our institution between January 1995 and December 2014.

Although the significance of preoperative nutritional status has been investigated, there is no report regarding the relationship of their postoperative changes on outcomes in patients who underwent radical cystectomy for bladder cancer.

Press Releases
Official Announcements on Clinical Developments
  • PADCEV plus Keytruda is the first and only regimen without platinum-based chemotherapy to improve event-free and overall survival when used before and after surgery in cisplatin-eligible patients with muscle-invasive bladder cancer
  • Positive EV-304 data, combined with the recent unprecedented results from the EV-303 trial, highlight the potential of this combination to become a new platinum-free standard of care in an earlier stage of bladder cancer
  • Results from the Phase 3 EV-304 trial will be presented at an upcoming medical meeting and discussed with global health authorities for potential regulatory filings
Reno, Nevada (UroToday.com) -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) announced positive topline results from an interim analysis of the Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15) for PADCEV™ (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with Keytruda® (pembrolizumab), a PD-1 inhibitor. This pivotal study is evaluating the combination as neoadjuvant and adjuvant treatment (before and after surgery) versus standard of care neoadjuvant chemotherapy (gemcitabine and cisplatin) in patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. The trial met its primary endpoint, demonstrating clinically meaningful and statistically significant improvements in event-free survival (EFS), and overall survival (OS), a key secondary endpoint.
  • Phase 1b study results were published simultaneously in Nature Medicine and presented at the Society for Immunotherapy of Cancer 2024
  • Encouraging data adds to the body of evidence supporting potential use of cretostimogene as a backbone bladder-sparing therapeutic for bladder cancer
Reno, Nevada (UroToday.com) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, announced the publication in Nature Medicine of Phase 1b investigator-sponsored study results evaluating intravesical cretostimogene grenadenorepvec in combination with Bristol Myers Squibb’s immune checkpoint inhibitor nivolumab, in muscle-invasive bladder cancer (MIBC). The publication is now available online and will be in a future print edition of Nature Medicine. The results were also presented at the Society for Immunotherapy of Cancer (SITC) 2024 by Dr. Roger Li, M.D., urologic oncologist at Moffitt Cancer Center.
Zachary Klaassen interviews Oliver Sartor about three significant prostate cancer trials presented at ESMO 2024. Dr. Sartor discusses the ARANOTE, PEACE-3, and the SPLASH trials.

Biographies:

Oliver Sartor, MD, Medical Oncologist, Professor of Medicine, Urology and Radiology, Director, Radiopharmaceutical Trials, Mayo Clinic, Rochester, MN

Zachary Klaassen, MD, MSc, Urologic Oncologist, Assistant Professor Surgery/Urology at the Medical College of Georgia at Augusta University, Well Star MCG, Georgia Cancer Center, Augusta, GA

Related Content:

ESMO 2024: Efficacy and Safety of Darolutamide plus ADT in Patients with mHSPC from the Phase 3 ARANOTE Trial

ESMO 2024: Radium-223 and Enzalutamide in Asymptomatic or Mildly Symptomatic Patients with Bone Metastatic Castration-Resistant Prostate Cancer: First Results of EORTC-GUCG 1333/PEACE-3

ESMO 2024: Efficacy of 177Lu-PNT2002 in PSMA-Positive mCRPC Following Progression on an Androgen-Receptor Pathway Inhibitor (SPLASH)
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TRANSCRIPT ID 4331 100824: Oliver Sartor - ESMO QuickTakes Videos

Zach Klaassen: Hi, my name is Zach Klaassen. I'm a urological oncologist at the Georgia Cancer Center. Welcome to ESMO 2024, Prostate Cancer Insights on UroToday. I am delighted to be joined for discussion with Dr. Oliver Sartor, who is a medical oncologist at Mayo Clinic in Rochester, Minnesota. Oliver, thanks so much for joining us today.

Oliver Sartor: Oh, delighted to do this, Zach. Looking forward to the discussion.

Zach Klaassen: It was a historic ESMO for many reasons. We saw multiple huge trials across the GU landscape, but specifically among prostate cancer. And so I'm going to pull up some slides for our discussion today, to go through three really important trials that we had presented in Barcelona.

Oliver Sartor: Thank you very much, Zach. And I'm going to be presenting some of the highlights from three particularly very important trials presented at ESMO 2024. This will be the ARANOTE, the PEACE-3, and the SPLASH.

The ARANOTE is hormone-sensitive prostate cancer. Here we go. And it's a Phase 3 trial, and this is presented by Fred Saad. One of the things—a little bit of background—so the ARASENS trial laid the foundation for darolutamide in the metastatic hormone-sensitive space, but the control group was ADT/docetaxel, and it was plus or minus darolutamide. Here we have a lot of simplicity, because it's just going to be ADT plus or minus the darolutamide. And again, Fred Saad presented this very important study.

Here's the design: metastatic hormone-sensitive prostate cancer, some stratification factors are visceral mets, prior local therapies. Randomized to ADT plus darolutamide in a two-to-one ratio, versus placebo plus ADT. And looking at the primary endpoint, rPFS, along with a variety of secondary endpoints including overall survival.

Primary endpoint—you can see, hit it really nicely. rPFS gone from a median of 25.0 months in placebo plus ADT, not yet reached in the darolutamide plus ADT. Hazard ratio very strong, 0.54. p-value less than 0.0001. Very nice primary endpoint. Now think a game changer here.

Pre-specified, there are a variety of pre-specified endpoints. You can see almost everything is going to be favoring darolutamide. A little bit of a call-out on disease volume—a little bit interesting. The lower volume patients seem to do particularly well. Look at that hazard ratio down in the 0.3 range, exceptionally strong for the low-volume subset.

Secondary endpoints: the overall survival is trending in the right direction. Hazard ratio is 0.81, still relatively immature, relatively small number of events—only 23.1% of the patients to reach an OS endpoint. Time to metastatic CRPC, positive. Time to PSA progression, positive. Time to initiation of subsequent systemic therapy, positive. And also positive for time to pain progression. So it's nice to see this trend across the multiplicity—the endpoints all favoring the darolutamide arm.

TEAEs of special interest: we have become accustomed to seeing a very good darolutamide AE profile, and we see it again here. There's very little differences between the placebo and the darolutamide arm, whether or not you're looking at mental impairment, hypertension, cardiac arrhythmias, etc., etc. You know, we have a very persistent good AE profile with darolutamide. And also not shown here, but it doesn't have much in the way of drug interactions, which is also important in these particularly elderly patients, often with polypharmacy.

Next, moving on to PEACE-3, presented at the Presidential by Silke Gillessen. Silke's great, as you all know—she had a fabulous presentation. Here we're going to be looking at the first-line metastatic CRPC space, but without a prior ARPI. And the randomization, as I'll show you in just a second, is everybody's going to get enzalutamide plus or minus the radium.

Here's the trial design: everybody had to have bone metastatic disease, which we would expect for a radium trial. Asymptomatic or mildly symptomatic—a little bit interesting there, because of course, radium had been approved for those who are symptomatic in the past. Good performance status. No prior treatment with enzalutamide or radium-223. No known visceral metastases, and ongoing ADT. I will say that there are very, very few patients with a prior ARPI of any type, not just the enzalutamide. Very few patients, so any type of ARPI.

Randomized to receive enzalutamide in both arms or the radium plus the enzalutamide. Primary endpoint rPFS, with a variety of secondary endpoints, including safety and overall survival. Very, very important.

Initially, the trial did not include bone-protecting agents—things like zoledronic acid or denosumab. In the initial phases of the trial, there were a substantial number of fractures, and as a consequence, the DMC mandated the inclusion of bone-protective agents in both arms of the trial. This is not just radium/enzalutamide/ADT, it's radium/enzalutamide/ADT and a bone-protective agent.

Primary endpoint, very clearly positive, hazard ratio of 0.69. Interestingly, you can see as time goes beyond the median that the curves split even more. But nevertheless, you have a good log-rank p-value, 0.0009. So unequivocally positive here for the rPFS primary endpoint.

If you look across the multiplicity of parameters within the forest plots, again, you see everything pretty much favoring the enzalutamide/radium arm. Important to see these pre-specified subgroups all being positive.

And here's the overall survival. And I'll mention, there's a little bit of controversy about the early quote, potential crossover in the arms in the initial phases prior to 18 months. I do want to make a statement, and that statement is, that differential that you see visually is not statistically significant. It was looked at—the confidence intervals are going to overlap completely between the two arms during these first 18 months. Then you go on and you see the split. And you see the hazard ratio of 0.69. The log-rank p-value is 0.0031. This does meet the pre-specified endpoint. And I'll simply say that it looks positive from a clinical perspective to me.

Now, statistical issue: there was some non-proportional hazards in the testing, and that is part of the pre-testing in the log-rank value analysis. So there are those statisticians who believe that we need to look further with more follow-up. I'm fine with that. But to me, this is a positive study right here, right now.

Safety: we do notice that there are more fractures—you can see in the arrow, 5.1% versus 1.3%. Please remember that initially the bone-protective agents were not included; later on, they were. When the bone-protective agents were included, this all seemed to balance out quite nicely. Otherwise, I think you see a very well-tolerated radium therapy. And I'll simply say that for those patients without a prior ARPI, that this is a practice-changing trial in my mind.

SPLASH trial: actually, I presented the SPLASH trial in Barcelona. This is the lutetium-177-PNT2002. This is also known as PSMA-I&T, and it is the SPLASH trial. All of these patients had PSMA-positive disease, and all of these patients have prior progression on an ARPI.

The SPLASH trial incorporates a trial very similar to what was seen with the PSMAfore trial. Here we get the PSMA-I&T with lutetium. Please note, the control arm, alternate ARPI, enzalutamide or abiraterone. Please note that the PNT2002 is being given as monotherapy, unlike, say, the ENZA-p trial that was presented by Louise Emmett, where she used enzalutamide plus or minus a lutetium-based therapy. rPFS is the primary endpoint.

The crossover—the crossover is really important here. Patients on the control arm who progress by central radiographic progression review could be allowed to cross over to the lutetium arm. 84.6% of the patients eligible for crossover in fact did cross over. So what we're going to see is we're going to see an rPFS that is not particularly altered by the crossover, but subsequent events, such as the overall survival, are going to be altered by this 84.6% crossover.

Primary endpoint, positive rPFS. You can see the hazard ratio, 0.71. p-value is 0.008. Confidence intervals do not overlap 1.

rPFS across a variety of pre-specified endpoints are positive. I'm going to do a little bit of a call-out. If you go down, second from the bottom, and look at the baseline PSA. If the baseline median is going to be on the low side for the PSA, the hazard ratio is pretty close to 1. That's because the patients on the control arm did exceptionally well, even with the secondary hormone. With these low PSAs, people do quite well with the secondary hormonal manipulation. On the other hand, if the PSA was greater than median, you can see that the hazard ratio was down to a 0.5, so very strikingly positive. So there was a distinction, in my mind, between those with the higher and the lower PSAs in this particular trial.

Overall response rate, again favoring the lutetium arm. You're going to have 38.1% versus 12%. p-value 0.0021. So again, favorable.

Interim overall survival analysis, first in. Hazard ratio is 1.11. We're looking at median around 20.8, and no distinction between the arms. But please remember that 84.6% crossover, which I think will dramatically alter the overall survival assessment. There's going to need to be more follow-up here.

Treatment-emergent adverse events favoring the lutetium arm. Here you can see those greater than grade 3, 30.1% versus 36.9% for an alternate ARPI. The serious TEAEs, 17.1% versus 23.1%. TEAEs related to death, I mean, 1.9% versus 3.8%. This is a very, very, very well-tolerated therapy. TEAEs with discontinuation, 1.9%. And lutetium, 6.2% in ARPI. Reduction in the dose, 1.1%. So again, very well-tolerated therapy.

Clinical implications: ARANOTE—a second pivotal trial of darolutamide, but this one is not inclusive of docetaxel. So we have a second metastatic hormone-sensitive prostate cancer-positive trial, this time without docetaxel, which I think will have clinical utility, because not everyone gets chemotherapy in hormone-sensitive disease.

PEACE-3: combination of enzalutamide and Ra-223 and a bone-protective agent is a new first-line metastatic CRPC treatment option, in my opinion, for those that had not received a prior ARPI. This is going to have to go to the regulators, and they're going to have to give an opinion.

SPLASH trial: second radioligand option. Here we have lutetium-PNT2002, otherwise known as I&T, presenting with a positive study in patients progressing after an ARPI. And I'll simply say, also have to see how the regulators will approach this one.

Thank you very much, Zach, for the opportunity to present three large, three important trials that came through at ESMO 2024.

Zach Klaassen: Yeah. Great job, Oliver. Thank you so much for your insight and expertise. It really was a wonderful meeting. It gets us excited for what's coming up at GU-ASCO in 2025. But we've seen some practice-changing data at this meeting, and your concise expert opinion was awesome today. Thank you so much.

Oliver Sartor: Glad to be able to do it. And I was in Barcelona, I was able to personally attend all the presentations. Fred Saad did a great job. Silke Gillessen did a great job. So it's really a pleasure to be able to see it firsthand at ESMO.

Zach Klaassen: Absolutely. Thanks again, Oliver.

Oliver Sartor: Okay. Bye-bye.
Does FAP Have a Future? Pro / Con "Presentation" - Wolfgang Fendler & Lena Unterrainer
Initial Experience with APC3 "Presentation" - Philipp Backhaus
Optimization of Radioligand Chemistry "Presentation" - John Babich
Scaling Operations in Theranostics Clinical Research: Integrating Teams, Processes, and Regulatory Strategy "Presentation" - Stephanie Lira
Review of Recently Published Therapeutic Radiopharmaceuticals in Phase 1/2 Trials "Presentation" - Jeremie Calais
Approaches to Early-Stage Development and Dose Optimization "Presentation" - Anna Karmann
How PCWG4 Impacts Future Trials "Presentation" - Michael Morris
Incorporating PSMA PETs in Registrational Trials "Presentation" - Alicia Morgans
PSMA PET in Prostate Cancer Drug Development: Regulatory Challenges and Considerations "Presentation" - William Maguire
Monitoring the Marrow: Hematologic Toxicity in the Treatment of Advanced Prostate Cancer "Presentation" - Daniel Childs
Renal Toxicity Associated with PSMA Targeted Therapy "Presentation" - Ines Camille Azrour
The Expanding Theranostic Dream: From Hype to Hard Truths "Presentation" - Michael Hofman
DLL3: Does Target Expression Determine the Method of Targeting? "Presentation" - Rahul Aggarwal
PSMA and Other Targets in Antibody-Drug Conjugates & Bispecific T-cell Engages "Presentation" - Tanya Dorff
Modalities for Targeting the Cell Surface "Presentation" - Evan Yu
Cancer Therapy: Target, Modality, and Timing "Presentation" - Owen Witte
Predicting Radiation Resistance and Response with ctDNA "Presentation" - Sofie Tolmeijer
PSMA-RPT Resistance Mechanisms and Relapse "Presentation" - Christine Mona
Tests that Predict Radiation Sensitivity: Experience from Space Travel "Presentation" - Kevin Tabury
Does Dosimetry Matter? "Presentation" - Stephen Graves
Enhancing Radiosensitivity: Non-PARP DNA Repair Enzymes and Optimal Combinations with Radioligand Therapy "Presentation" - Jonathan Chou
How Important are Bystander Effects in Targeted Radionuclide Therapy? "Presentation" - Jean-Pierre Pouget
Are Alpha or Beta Particles Better for Immunogenic Priming? "Presentation" - Zachary Morris
Immunotherapy Beyond Checkpoint Inhibitors "Presentation" - Lawrence Fong
Lessons Learned from Radioligand Combinations "Presentation" - Shahneen Sandhu
How We Get to the Isotope "Presentation" - Jonathan Engle
Market and Raw Materials: "Stable Isotopes" Why are They so Important and Where to Find Them? "Presentation" - Nicolas Mario
The Theranostic Revolution: Innovation, Investment, and Implications "Presentation" - Germo Gericke
Does Dose Rate Matter? "Presentation" - Amanda Walker
Ac-PSMA: The Truth Should be Told! "Presentation" - Matthias Eiber
Is Astatine the Way to Go? "Presentation" - Tadashi Watabe
STAMPEDE2 PSMA-Lu Comparison "Presentation" - Nicholas James
Chemo versus PSMA RLT "Presentation" - François Bérnard
The PEACE-6-PR Trial "Presentation" - Désirée Deandreis
DORA and PEACE-3: Evolving Role of Ra-223 "Presentation" - Michael Morris
PSMAddition "Presentation" - Oliver Sartor
Does What We See on PSMA PET Matter? "Presentation" - Peter Choyke
SPECT Versus PET: Optimizing Response Biomarkers "Presentation" - Lisa Bodei
The Problem with Our Reports "Presentation" - Robert Reiter
Nuclear Medicine in Prostate Cancer Care "Presentation" - Johannes Czernin
Annual PSMA & Beyond Meeting Focuses on Clinical Trials, Biomarkers, and Unmet Needs - Thomas Hope & Jeremie Calais
IBCG Task Force Plan to Develop Patient-Reported Outcome Tool for Bladder Cancer - Sarah Psutka
IBCG Recommendations for Intermediate-Risk NMIBC Definitions and Management - Roger Li
Limitations of Urine-Based Biomarkers for Replacing Cystoscopy in Hematuria - Wei Shen Tan
Multidisciplinary and Global Perspectives on Bladder Cancer Management - Shilpa Gupta, Patrick Hensley & Roger Li
Assessing Baseline Bladder Function for Patients Considering Trimodal Therapy - Comron Hassanzadeh
Assessment of Urine-Based Tests and Adjuncts in Bladder Cancer Guidelines - Laura Bukavina
International Initiative to Define and Quantify Local Bladder Side Effects - Patrick Hensley
Addressing Limitations in Current Toxicity Reporting for Bladder Cancer Therapies - Shilpa Gupta
Biomarkers for Guiding Bladder Cancer Treatment Decisions - Andrea Necchi
RNA and DNA Biomarkers in Trimodal Therapy for Bladder Cancer - Kent Mouw
Darolutamide Improves Outcomes in Metastatic Hormone-Sensitive Prostate Cancer Without Chemotherapy - Fred Saad
Selecting Patients for Triplet Therapy in Metastatic Prostate Cancer - Oliver Sartor
Evolution of Chemohormonal Therapy for Metastatic Prostate Cancer - Pedro Barata
ARANOTE Study Shows Benefits of Deep PSA Response with Darolutamide - Neal Shore
Evolution of Treatment Approaches for Metastatic Hormone-Sensitive Prostate Cancer - Pedro Barata
Optimizing Multidisciplinary Care for Metastatic Hormone-Sensitive Prostate Cancer - Zachary Klaassen
PSA Responses with Darolutamide Plus ADT in the ARANOTE Trial - Fred Saad
ARANOTE Trial Explores Darolutamide’s Role in High and Low-Volume Metastatic Prostate Cancer - Fred Saad
Press Releases
Official Announcements on Clinical Developments
  • Three abstracts to be presented at the 101st Annual Meeting of the Western Section of the American Urological Association, including baseline characteristics and demographics for patients enrolled in the ADSTILADRIN in BLadder CancEr (ABLE)-41 real-world study
  • Independent analysis based on billing records to report on the durability of ADSTILADRIN use in patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) 
  • First real-world case series to highlight ADSTILADRIN re-induction in patients without a complete response to initial treatment

  • Patients with high-risk, non-muscle invasive bladder cancer now have greater access to the first and only FDA-approved intravesical gene therapy
  • With full supply of ADSTILADRIN ahead of schedule, Ferring ends the temporary ADSTILADRIN Early Experience Program
  • Enrollment in ABLE-41 U.S. Real-World Evidence Study is ongoing
  • Ferring’s novel adenovirus vector-based gene therapy Adstiladrin® (nadofaragene firadenovec-vncg) is the first gene therapy approved for bladder cancer
  • Efficacy and safety of Adstiladrin supported by Phase 3 results demonstrating that more than half of patients (51% of CIS ± Ta/T1 cohort) achieved a complete response (CR) at three months and of these, 46% continued to remain free of high-grade recurrence at 12 months
  • Bladder cancer is the sixth most common cancer in the U.S.; Adstiladrin provides NMIBC patients a valuable alternative compared to an invasive bladder removal surgery
Durable responses in 35 percent of patients reported in Phase II data published in the Journal of Clinical Oncology

Truckee, CA., [August 27, 2017] – The Society of Urologic Oncology and the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC) announced that the Journal of Clinical Oncology (JCO) has published results from a Phase II clinical study led by the SUO- CTC demonstrating the potential effectiveness of Nadofaragene firadenovec (Adstiladrin®) (rAD-IFN/Syn3) in patients with high grade, BCG refractory or relapsed Non-Muscle Invasive Bladder Cancer (NMIBC).
Press Releases
Official Announcements on Clinical Developments
Las Vegas, Nevada (UroToday.com) -- Novartis announced new data from PSMAddition demonstrating improved prostate-specific antigen (PSA) responses with Pluvicto® (lutetium (177Lu) vipivotide tetraxetan) combined with standard of care (SoC) in PSMA-positive metastatic hormone sensitive prostate cancer (mHSPC). Data were presented as a rapid oral presentation at the American Urological Association Annual Meeting 2026.
Reno, Nevada (UroToday.com) -- Novartis presents new Pluvicto™ (lutetium (177Lu) vipivotide tetraxetan) data from the Phase III PSMAddition trial in a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2025.
Phase 3 INDICATE Trial for Patients with Biochemically Recurrent Prostate Cancer - Neha Vapiwala
Biomarker Data from Phase II PT-112 Trial in Heavily Pretreated mCRPC - Alan Bryce
Phase 3 KEYNOTE-905 Trial Investigates Enfortumab Vedotin Plus Pembrolizumab in Cisplatin-Ineligible Bladder Cancer - Christof Vulsteke
ALBAN Trial Analysis: Evaluating Atezolizumab Addition to BCG Therapy in High-Risk, Non-Muscle-Invasive Bladder - Morgan Rouprêt
Final Analysis of Phase 3 POTOMAC Study in High-Risk NMIBC - Maria De Santis
Phase 1 Dosing Strategy and Translational Findings for Investigational Therapy Pasritamig - Karen Autio
Phase II NESCIO Trial of Neoadjuvant Immunotherapy in Renal Cell Carcinoma - Femke Burgers
Phase 2 Formula-01 Study Evaluates DV Combined With BCG for HER2-High NMIBC - Xingliang Tan
Clinical and Molecular Criteria for Aggressive Variant Prostate Cancer - Ana Aparicio
KIM-1 Biomarker Evaluated for Association with Outcomes in Advanced RCC Treatment - Wenxin Xu
PSMACare: Early Lutetium RLT in High-Risk nmCRPC - Fred Saad
KEYMAKER-U03 Substudy Compares Four Combinations to Standard Therapy - Cristina Suárez
Biomarker Analysis from the SunRISe-1 Trial in BCG-Unresponsive CIS - Félix Guerrero-Ramos
Optimizing Advanced Prostate Cancer Care: Balancing Intensification and Overtreatment - Gerhardt Attard
COSMIC-313 Correlative Analysis Links Specific T-Cell Subset to Improved PFS with Immunotherapy - Berkay Simsek
LenCabo Phase II Trial Investigates Lenvatinib-Everolimus vs Cabozantinib in Relapsed Kidney Cancer - Andrew Hahn
Phase 2 ALPACA Trial Evaluates Avelumab in Advanced Penile Cancer - Srikala Sridhar
Phase Ib/II Trial Combines Ciforadenant with Ipilimumab and Nivolumab in Frontline Kidney Cancer - Kathryn Beckermann
ARTISAN Trial: Evaluating Lead-212 PSMA Therapy for Advanced Prostate Cancer - Oliver Sartor
The Phase III ENZARAD Trial: Enzalutamide with Radiation and ADT in High-Risk Prostate Cancer - Paul Nguyen
A SEER Database Analysis of Real-World Survival Trends in Metastatic Prostate Cancer - Pedro Barata
Analysis of Patient-Reported Quality of Life from the AMPLITUDE Trial - Eleni Efstathiou
Feasibility of Using an RNA-Seq Biomarker to Assign Therapy in the OPTIC RCC Trial - Pedro Barata
PARP Inhibitors in Prostate Cancer: A Decade of Development and the Combination vs Monotherapy Debate for HRR-Mutated Disease - Neeraj Agarwal
EMBARK Trial Reports Overall Survival Benefit for Enzalutamide with ADT in High-Risk Non-Metastatic Prostate Cancer - Stephen Freedland
Phase III CAPItello-281 Trial Results for mHSPC with PTEN Loss - Karim Fizazi
CAPItello-281: Targeting the AKT Pathway in PTEN-Deficient mHSPC Presentation - Daniel George
Health-Related Quality of Life Outcomes from the NIAGARA Trial in Bladder Cancer - Michiel Van Der Heijden
Final Results of the SunRISe-4 Study in Muscle-Invasive Bladder Cancer - Andrea Necchi
Phase 2 Trial of Neoadjuvant Nivolumab and Visugromab in Bladder Cancer Patients - Andrea Necchi
Analysis of MRI Use in the Diagnostic Pathway for Bladder Cancer - Nicholas James
Evaluating Chemotherapy De-Escalation in First-Line Urothelial Carcinoma: DISCUS Trial - Enrique Grande
Pre-ESMO 2025 Highlights - Rashid Sayyid & Zachary Klaassen
EMBARK Trial Reports Overall Survival Benefit for Enzalutamide with ADT in High-Risk Non-Metastatic Prostate Cancer - Stephen Freedland
EMBARK Subgroup Analysis: Enzalutamide Monotherapy Effective Regardless of Prior Definitive Therapy - Stephen Freedland
EMBARK Analysis: Testosterone Recovery Post-ADT in High-Risk Prostate Cancer Patients - Stephen Freedland
EMBARK Trial: Treatment Options for High-Risk Biochemical Recurrence - Neal Shore
Comparing EMBARK vs EAU High-Risk Biochemical Recurrence Criteria in Prostate Cancer - Ugo Falagario
EMBARK Trial Subanalysis for High-Risk Biochemical Recurrent Prostate Cancer - Stephen Freedland
EMBARK Trial: Age-Stratified Analysis of Enzalutamide in High-Risk Biochemically Recurrent Prostate Cancer - Neal Shore
EMBARK Trial: Enzalutamide Monotherapy & Combination Therapy for High-Risk Prostate Cancer - Stephen Freedland, Neal Shore & Rana McKay
EMBARK Trial: Enzalutamide Monotherapy and Combination Therapy for High-Risk Biochemical Recurrence - Neal Shore
The Impact of the EMBARK Trial on Treatment Decisions in High-Risk Biochemical Recurrent Prostate Cancer - Neal Shore
Advancing Prostate Cancer Care: The EMBARK Study and Implications for Clinical Practice - Stephen Freedland
Novel Hormone Therapy and Coordination of Care in High-Risk Biochemically Recurrent Prostate Cancer - Beyond the Abstract
Parsing the Evidence from the EMBARK Trial on a Promising New Drug Regimen in High-Risk Non-Metastatic Hormone-Sensitive Prostate Cancer - Matthew Cooperberg
Interpreting EMBARK Trial Results: Intensified Treatment and Hormone Therapy in High-Risk Patients - Christian Gratzke
EMBARK Trial Shows Promising Results for High-Risk Prostate Cancer Treatment, Enzalutamide's Impact on Metastasis-Free Survival - Neal Shore
The EMBARK Study: A Phase 3 Randomized Study of Enzalutamide Plus Leuprolide and Enzalutamide Monotherapy in High-Risk Nonmetastatic Hormone-Sensitive Prostate Cancer with Rising PSA After Local Therapy - Stephen Freedland
Expanding Bladder Cancer Trials and Multidisciplinary Membership in the SUO-CTC - Trinity Bivalacqua
Centroid-Based vs. Network-Based Travel Distance and Its Impact on Bladder Cancer Outcomes - Jacqueline Fannin
The MEVPRO-2 Phase 3 Trial of Mevrometostat plus Enzalutamide in ARPI-Naive mCRPC - Neal Shore
Cost-Effectiveness of BCG plus Immune Checkpoint Inhibitors in High-Risk NMIBC - Daniel Joyce
An Electronic Medical Record-Based Tool for Standardizing Bladder Cancer Surveillance and Treatment Pathways - Benjamin Tooke
PATAPSCO Safety Data for BCG plus Durvalumab in High-Risk NMIBC - Mark Tyson
Interim Phase 2 LEGEND Trial Results for Detalimogene in BCG-Unresponsive NMIBC - Ashish Kamat
Computational AI for Predicting Grade Progression in Intermediate-Risk Bladder Cancer - Roger Li
The MoonRISe-2 Trial and FGFR-Targeted Ablative Therapy in NMIBC - Christopher Pieczonka
Perioperative Outcomes After Radical Surgery Following EV Pembrolizumab in Urothelial Carcinoma - Daniel Roberson
A Genomic Score to Predict Early BCG Failure in High-Grade NMIBC - Jacob Lang & Eugene Pietzak
How PSMA PET Restaging Reshapes the EMBARK High-Risk BCR Population - Alessandro Viti
Evaluating Intermediate Surrogate Endpoints in Perioperative Bladder Cancer Trials - Pietro Scilipoti
Interim Results from the ADVANCED-2 Trial of TARA-002 in BCG-Unresponsive CIS Bladder Cancer - Timothy Clinton
Intermediate-Risk Bladder Cancer Management Through Risk Stratification, Office Ablation, and Chemoablation - Joan Palou & Akshay Sood
Real-World Trends in ADT Intensification for mHSPC from the Swedish Prostate Cancer Register - Paolo Zaurito
Prior Therapy, Genomics, and Patient Factors in mCRPC Treatment Selection - Kristine Lacuna
Engineered Salmonella as Intravesical Therapy for Recurrent Bladder Cancer - Michael Oefelein
BCG Plus Immune Checkpoint Blockade for High-Grade T1 Bladder Cancer with CIS - Eugene Pietzak
Managing Coexisting Bladder Outlet Obstruction and Overactive Bladder in Men - Rachael Sussman
Patient and Urologist Perspectives from the Bladder Burden Survey - Alex Filicevas
ARASEC Design and Sensitivity Analyses of Darolutamide plus ADT in Metastatic Hormone-Sensitive Prostate Cancer - Rana McKay
Real-World Testosterone Recovery After Relugolix: Interim Results from the OPTYX Registry - Benjamin Lowentritt
Debating First-Line Treatment for BCG-Unresponsive Bladder Cancer - Bogdana Schmidt & Amanda Myers
Pilot Study Results for NDV-01 Intravesical Therapy in BCG-Unresponsive Bladder Cancer - Boris Chertin
Immune Microenvironment Changes and Response to Cretostimogene in Bladder Cancer - Taylor Goodstein
Combining Focal Irreversible Electroporation with Hypofractionated Radiation: The Phase 3 IRRADIANT Study - Timothy McClure
Cost-Effectiveness Modeling of BPH Surgical Treatments - Kevin Wymer
Intravesical Anti-Nectin-4 ADC in NMIBC: Phase 1/2 Trial Design and Tolerability - Joshua Meeks
PROSTest mRNA Assay Tested for Response Prediction to Lutetium PSMA in mCRPC - Mark Kidd
Ten-Year Results of Extended Versus Limited Lymph Node Dissection in High-Risk Prostate Cancer - Jean Lestingi & Matheus Ruggeri
MoonRISe-3 Trial Design and Enrollment: Erdafitinib Drug-Releasing System in FGFR-Altered Bladder Cancer - Brian Mazzarella
BCG-Unresponsive Bladder Cancer Care in Community Practice - Gautam Jayram
Radiation to the Primary in De Novo mHSPC - Daniel Spratt
More Than a Diagnosis: Global Survey Exposes the Emotional and Physical Toll of Bladder Cancer Treatment - Gina Carithers
Neoadjuvant Apalutamide for Potency Preservation in High-Risk Prostate Cancer: A Randomized Trial - Isaac Kim
Radiographic Progression-Free Survival and Overall Survival Correlation in TALAPRO-2 - Neeraj Agarwal
Doublet Versus Triplet Intensification in Metastatic Hormone-Sensitive Prostate Cancer - Jacqueline Brown
Lutetium-177-PSMA-617 in First-Line mHSPC and Its Impact on PSA Depth, Undetectable Rates, and Time to Progression - Fred Saad
A Multicenter Trial on Imaging-Guided Radiation Decisions in Biochemically Recurrent Prostate Cancer - Vidit Sharma
Bladder Burden Survey Findings on Patient Trust, Unspoken Struggles, and Mental Health in Bladder Cancer - Ashish Kamat
Implementation of the PC360 Algorithm to Manage Cardiovascular and Bone Health Risks on ADT - Jason Hafron
CORE-008 Cohort CX: Early Results of Cretostimogene plus Gemcitabine in BCG-Unresponsive and BCG-Exposed NMIBC - Trinity Bivalacqua
CAN-2409 in Localized Prostate Cancer: Protocol, Outcomes, and Patient Perspective - Mark Garzotto & Tom Hulsey
Findings from the Bladder Burden Survey: Patient Perspectives on Communication, Trust, and Quality of Life in Bladder Cancer - Meri-Margaret Deoudes
Non-Surgical Management of Non-Muscle Invasive Bladder Cancer: Surveillance, Chemoablation, and Office-Based Approaches - Katie Murray
Extended Data Cut: CAN-2409 with Valacyclovir and Radiation for Localized Prostate Cancer - Mark Garzotto
First-Line Therapy Determines Bladder Preservation in High-Grade NMIBC - Peter Black
Real-World Claims Analysis of Blue-Light Cystoscopy in NMIBC – Mark Tyson
AUA 2026 Bladder Cancer Presentations: EG70, POTOMAC, and En-bloc Resection - Patrick Hensley
AUA 2026 Preview: Perioperative EV/Pembro, ctDNA, and Bladder Preservation - Petros Grivas
AUA 2026 Bladder Cancer Program: Focus on BCG-Naive Intensification Trials - Bogdana Schmidt
Comparing Cognitive Change on Enzalutamide and Darolutamide in the ARACOG Trial - Alicia Morgans
Navigating Treatment Decisions in Castration-Resistant Prostate Cancer - Karim Fizazi
PROTEUS Trial Results for Apalutamide plus ADT Before and After Radical Prostatectomy - Fred Saad
ABBV-969, a Dual-Targeted PSMA-STEAP1 ADC in Heavily Pretreated mCRPC - Tanya Dorff
Predicting Docetaxel Benefit with a Genomic Classifier in mHSPC - Christopher Sweeney
De-escalation of ADT and AR Pathway Inhibitors in mHSPC: The A-DREAM Trial - Atish Choudhury
PROTEUS Trial: Neoadjuvant Apalutamide and Androgen Deprivation Therapy in High-Risk Localized Prostate Cancer - Mary-Ellen Taplin
Trials in Prostate and Kidney Cancer Featured at ASCO 2026 - Rana McKay
A Phase II Trial of VEGFR-TKI Plus PD-1 Inhibitor in Non-Clear Cell Renal Carcinoma - Jiwei Huang
PEACE-2 Trial of Cabazitaxel with ADT and Radiotherapy in Very High-Risk Localized Prostate Cancer - Karim Fizazi
First-in-Human Trial of a Robotic System for Transurethral Bladder Tumor Resection - Jeremy Teoh
KIM-1 Biomarker Analysis in the CAN-I Trial for Non-Clear Cell RCC - Wenxin Xu
Large-Scale Data Linkage Reveals Genomic Differences in De Novo Metastatic Prostate Cancer - Shalini Moningi
Surgical Management of NMIBC: Comparing En Bloc to Standard Resection Techniques - Jeremy Teoh
Evaluating the Case Against Combining Immune Checkpoint Inhibitors with BCG in Non-Muscle-Invasive Bladder Cancer - Félix Guerrero-Ramos
Prospective Study Investigates ctDNA as an Adjunct to Endoscopic Evaluation Before Cystectomy - Matthew Zibelman
CHHiP Trial Evaluates a Multimodal AI Biomarker in Localized Prostate Cancer - Anna Wilkins
Real-World Data Explores Post-177Lu-PSMA-617 Therapies in Advanced Prostate Cancer - Xiao Wei
SunRISe-4 Examines Neoadjuvant Cetrelimab and Gem-iDRS Prior to Cystectomy in Cisplatin-Ineligible Patients - Sarah Psutka
ADT Class and Cardiovascular Risk: A Large Retrospective Analysis in Prostate Cancer - Andrew Hahn
EV-PRIME: Enfortumab Vedotin and Pembrolizumab with Radiation in Patients Declining Cystectomy - Vadim Koshkin
Whole-Genome Sequencing-Based MRD Detection Under Study in Resectable Renal Cell Carcinoma - Taigo Kato
ProTACT Trial Investigates Next-Generation PSMA-Targeted Alpha Therapy for mCRPC - Aaron Hansen
Study Explores Biologic Pathways Underlying AI-Based Biomarker in Oligometastatic Prostate Cancer - Amol Shetty
Machine Learning Models Aim to Quantify Vulnerability in Geriatric Oncology Patients - Sarah Psutka
Prostate Cancer Working Group 4 Addresses PSMA PET as a Clinical Trial Endpoint - Michael Morris
Q-TWIST Analysis Applied to ARASENS Trial in Metastatic Hormone-Sensitive Prostate Cancer - Brigida Maiorano
NIAGARA Trial Explores Urinary Tumor DNA as a Biomarker in Bladder Cancer - Michiel Van Der Heijden
Early Access Program for Cretostimogene Opens Enrollment in BCG-Unresponsive Bladder Cancer - Sarah Psutka
Artificial Intelligence Applied to TURBT Specimens in Muscle-Invasive Bladder Cancer - Yair Lotan
Radium-223 Monotherapy Explored in PSMA-Positive Bone Lesions Without Conventional Imaging - Melissa Abel
Phase I PAnTHA Study Evaluates PSMA-Targeted Actinium-225 in mCRPC Patients - Fred Saad
ECOG-ACRIN 8192 Evaluates Preoperative Gemcitabine Plus Durvalumab in Cisplatin-Ineligible UTUC - Jeannie Hoffman-Censits
Indi-Blade Study Tests Ipilimumab-Nivolumab Followed by Chemoradiotherapy in Advanced Bladder Cancer - Michiel Van Der Heijden & Jan-Jaap Mellema
Predicting Non-Cancer Mortality Risk in mHSPC Following Doublet Therapy Using STAMPEDE Data - Noel Clarke
KEYMAKER Substudy Tests Triplet Combinations with EV-Pembro in First-Line Bladder Cancer - Avivit Peer
LITESPARK-024: Belzutifan Plus Palbociclib in Advanced Clear Cell RCC - David McDermott
Darolutamide Alone for Non-Metastatic CSPC: 52-Week Safety and Efficacy Results from the ARAMON Trial - Andrew Laccetti
PSMA PET in Biochemically Recurrent Prostate Cancer a Natural History Study Observing Men with PSMA Positive Findings - Melissa Abel
Patient Selection for Intermittent Therapy: The Role of PSA Nadir and Disease Volume - Maha Hussain
Working Group 4 Introduces Updated Terminology for Advanced Prostate Cancer - Andrew Armstrong
CIPHER Trial Investigates Carboplatin in mCRPC Patients with HRR Mutations - Atul Batra
PCWG4 Amends Terminology and Biomarker Standards for Advanced Prostate Cancer - Andrew Armstrong
PEACE-3 Trial Evaluates Radium-223 Plus Enzalutamide in Bone-Metastatic mCRPC - Enrique Gallardo Diaz
Patient-Reported Outcomes and Qualitative Insights Inform Shared Decision-Making for Mitomycin Intravesical Solution - Ruchika Talwar
BRCAAway Trial Investigates Combination Versus Sequencing of ARPI and PARP Inhibitor in mCRPC - Maha Hussain
EV-PRIME Assesses Safety and Efficacy of Combined Systemic and Local Therapy in MIBC - Raj Satkunasivam
Phase 2 TheraPb Trial Evaluates a Novel Induction and Maintenance Regimen of 212Pb-ADVC001 Across Three Metastatic Prostate Cancer Indications - Anna Karmann
GUNS Trial Examines Biomarker‑Selected Neoadjuvant Approaches in High‑Risk Prostate Cancer - Martin Gleave
EZH2 Inhibition Combined with ARPI Evaluated in Patients with Castration-Resistant Prostate Cancer - Nobuaki Matsubara
HCRN GU 20-444: Pembrolizumab After TURBT for Bladder‑Sparing in Cisplatin‑Ineligible MIBC - Jonathan Anker
BOND-003 Cohort C: Cystectomy Outcomes Following Cretostimogene in BCG-Unresponsive NMIBC - Gary Steinberg
Obrixtamib Monotherapy Assessed in DLL3-Selected Extrapulmonary Neuroendocrine Tumors - Nil Navarro-Gorro
Cluster-Randomized Trial Targets Barriers to Mainstream Germline Testing for Veterans - Daniel Kwon
Real‑World Use of Radium‑223 in Veterans with Metastatic CRPC: A National Analysis - Martin Schoen
Phase III Trial Compares BCG Strains and Priming in Non-Muscle-Invasive Bladder Cancer - Robert Svatek
mHSPC Treatment Selection: ARPI Backbone, Biomarkers, and Docetaxel – Christopher Sweeney
Phase II Trial of Neoadjuvant Sasanlimab and SBRT as an In Situ Vaccine in Cisplatin-Ineligible MIBC - Raj Satkunasivam
Real-World Analysis of Lutetium-177 in mCRPC by Taxane Treatment Sequence - Micah Ostrowski
PSA Control After Treatment Suspension: EMBARK Data at 36 Months - Neal Shore
Combining PSMA PET and Genomic Risk Assessment in High-Risk Prostate Cancer - Sophia Coraci
SWOG 2427 Tests Immunotherapy Plus Radiation After Neoadjuvant Therapy for Bladder Cancer - Leslie Ballas
SURE-02 Trial Investigates Sacituzumab Plus Pembrolizumab in Bladder Preservation Approach - Andrea Necchi
Graphical Reconstruction Method Compares Neoadjuvant Regimens in Cisplatin-Ineligible MIBC - Brigida Maiorano
ctDNA Dynamics in Advanced Urothelial Cancer - Jeannie Hoffman-Censits
Biomarker-Based Classification Evaluated for Predicting Progression in High-Risk NMIBC - Joep de Jong
Large-Scale Analysis Examines Inherited DNA Damage Repair Genes in Advanced Prostate Cancer - Sofie Tolmeijer
OPTIMAS Trial: Testing Intermittent Therapy in Metastatic Hormone-Sensitive Prostate Cancer - Umang Swami
Reimagining Cancer Care: The Role of Artificial Intelligence in Clinical Delivery - Eliezer Van Allen
RAMPART Study Investigates Quality of Life Impact of Durvalumab and Tremelimumab in RCC - Sophie Merrick
Patient-Reported Outcomes in NMIBC Trials: A 30-Year Analysis of Incorporation Trends - Patrick Hensley
Masofaniten Combined with Enzalutamide Investigated in Metastatic Hormone-Sensitive Prostate Cancer - Albert Jang
POSEIDON Meta-Analysis Re-examines the Role of ADT with Salvage Radiation for Prostate Cancer - Amar Kishan
CYTOSHRINK: Evaluating SBRT to the Primary Tumor in De Novo Advanced RCC - Aly-Khan Lalani
Selective PARP1 Inhibition Combined with ARPIs Under Investigation in the PETRANHA in mHSPC - Arun Azad
Longitudinal Analysis of Patient-Reported Outcomes in the PSMAddition Trial - Michael Morris
Salvage Radiotherapy Intensification Tested in Men with High-Risk Biochemical Recurrence - Edwin Posadas
Phase I Trial Explores Formulation of CBM588 Probiotic in Advanced RCC - Miguel Zugman
MTAP Loss and Key Alteration Detection via Liquid Biopsy Explored in Bladder Cancer - Chiara Mercinelli
BCAN Unveils Patient-Centered Survey on Emotional and Financial Impacts of Bladder Cancer - Meri-Margaret Deoudes
ECLIPSE Trial Explores Dosimetry for PSMA-Targeted Therapy in mCRPC - Frankis Almaguel & Jason Hafron
Revisiting Radiation for Non-Muscle-Invasive Bladder Cancer - Ananya Choudhury
ASCENDE-RT Trial Reports 15-Year Survival Update in High-Risk Prostate Cancer - Scott Tyldesley
K-COMPASS Study Investigates ctDNA and KIM-1 in Oligometastatic Kidney Cancer - Chad Tang
JAVELIN Bladder Medley: Evaluating Checkpoint Inhibitor Combinations After Chemotherapy - Jeannie Hoffman-Censits
IMvigor011 Explores ctDNA Dynamics in Adjuvant Therapy for Urothelial Cancer - Thomas Powles
OMAHA-003 Trial Explores CYP11A1 Inhibition in Metastatic Castration-Resistant Prostate Cancer - Evan Yu
Evaluating EV Plus Pembrolizumab in Muscle-Invasive Bladder Cancer: KEYNOTE-B15 Results - Matthew Galsky
PAM50 Intrinsic Subtyping and Salvage Therapy Decisions After Prostatectomy - Jonathan Tward
Integrating Genomic Prognostic and Hallmark Signatures to Predict Outcomes in Active Surveillance - Kevin Shee
Correlation Between Genomic Classifier Scores and Upfront Treatment Selection in Localized Prostate Cancer: A Real-World U.S. Population-Based Cohort Study - Michael Leapman
Phase III SunRISe-2 Trial Compares Gem-iDRS and Cetrelimab to Chemoradiation for MIBC Bladder Preservation - Andrea Necchi
IZABRIGHT Trial Tests Dual HER1/HER3 ADC Against Platinum Chemotherapy in Urothelial Cancer - Thomas Powles
Investigating Pembrolizumab Alone with Response-Guided Bladder Sparing in MIBC - Matthew Galsky
ENVISION Trial Analysis: Reverse Thermal Gel with Mitomycin Outcomes by EORTC Risk Group – William Huang
ctDNA to Guide Response-Adapted Bladder Preservation in MIBC: Investigating a Strategy from the Integrated RETAIN Trials Analysis - Pooja Ghatalia
MEVPRO-3 Trial: Testing EZH2 Inhibition in First-Line Metastatic Hormone-Sensitive Prostate Cancer - Neeraj Agarwal
Global Phase II Trial Explores HER2-Directed Therapy Across Multiple Expression Levels - Thomas Powles
ASCO GU 2026 Preview: Trials in Bladder and Upper Tract Cancer - Petros Grivas
Perioperative Immunotherapy Versus Risk-Adapted Adjuvant Therapy in MIBC - Patrizia Giannatempo & Thomas Powles
Managing Radiation Toxicity After Trimodal Therapy for Bladder Cancer - Antoine Van Der Heijden & Neha Vapiwala
Bladder Preservation After Neoadjuvant EV+Pembrolizumab - Bogdana Schmidt & Fernando Maluf
Cystoscopy vs Urinary Markers: A Debate on Bladder Cancer Surveillance Strategies - Jeremy Teoh & Laura Mertens
Radiopharmaceuticals in Prostate Cancer Part 1: Current Landscape and Unmet Needs - Dustin Boothe & Praful Ravi
Radiopharmaceuticals in Prostate Cancer Part 2: Mechanisms and Clinical Considerations - Philip Kantoff, Ken Herrmann & Neil Bander
Radiopharmaceuticals in Prostate Cancer Part 3A: Patient Selection and Treatment Sequencing - Tanya Dorff, Neal Shore & Dustin Boothe
Radiopharmaceuticals in Prostate Cancer Part 3B: Radiation Safety, Patient Selection, and Clinical Gaps - Tanya Dorff, Neal Shore & Dustin Boothe
Radiopharmaceuticals in Prostate Cancer Part 4A: Endpoints, Immunotherapy, and Future Directions - Michael Morris & Rana McKay
Radiopharmaceuticals in Prostate Cancer Part 4B: Payloads, Carriers, Targets, and Combinations - Michael Morris & Rana McKay
Pasritamig Bispecific Antibody in Metastatic Castration-Resistant Prostate Cancer - Mark Stein
Study Examines Racial Disparities in PSMA-PET Imaging Utilization for Metastatic Prostate Cancer - Eunice Hankinson
ABLE-22 Trial: Comparing Combination Therapies for BCG-Unresponsive Bladder Cancer - Siamak Daneshmand
COMRADE Trial: Radium-223 Plus Olaparib in Bone-Predominant mCRPC - Rana McKay
Pasritamig Safety and Efficacy Data from Metastatic CRPC Phase I Study - Capucine Baldini
Study Examines Association Between Universal Healthcare and Cancer Outcomes - Edward Christopher Dee
EVOLUTION Trial: Ipilimumab/Nivolumab Plus Lutetium-PSMA Improves mCRPC Outcomes - Shahneen Sandhu
Darolutamide in AR-Altered mCRPC: Biomarker-Selected Phase II Trial Results - Michael Ong
CAN-2409 + Radiation Improves Disease-Free Survival in Prostate Cancer Patients - Angela Jia
Xaluritamig vs. Standard Care: A Phase 3 Trial for ARPI/Taxane-Refractory mCRPC - William Kevin Kelly
C3NIRA Trial Findings in High-Risk Prostate Cancer Population - Ana Aparicio
Radium-223 + Enzalutamide in mCRPC: Revisiting PEACE-3 Trial Data - Kristine Peregrino Lacuna
Real-World Analysis Confirms Enfortumab Skin Toxicity Predicts Better Survival in Bladder Cancer - Martin Kurian
ICECaP Meta-Analysis Explores Docetaxel's Benefit in Very High-Risk Prostate Cancer - Praful Ravi
Differential Treatment Responses Across HRR Gene Alterations in Prostate Cancer - Stefanie Zschäbitz
Trial Explores Nab-paclitaxel/Nivolumab Combination in Cisplatin-Ineligible Bladder Cancer - Chiara Mercinelli
PSA Thresholds in mHSPC: What VA Data Reveals About Optimal Targets - Stephen Freedland
Medley Study Demonstrates Improved PFS of Avelumab-Sacituzumab in Maintenance Setting - Jean Hoffman-Censits
Dissecting Tumor Mutational Burden and Microsatellite Instability in mCRPC: Differential Responses to Immune Checkpoint Inhibitors - Nicolas Sayegh
Personalizing Lutetium-177 Dosing: The FLEX-MRT Trial Approach - Adrien Holzgreve
HRR Gene Defects Predict Rapid Progression in mHSPC Patients - Elena Castro & David Olmos
Lutetium Lu 177 Timing Study: Early vs. Late Post-Chemo PSA Response - Eman Ahmed & Jack Andrews
Circulating Tumor Cell Phenotypes and Genomic Mutations Stratify mCRPC Risk - Marina Sharifi
Combination HIF-2α/VEGF Dual Inhibition in Refractory Clear Cell RCC - Michael Serzan
Event-Free Survival and Emerging Immunotherapy Approaches in High-Risk NMIBC - Neal Shore
SUVmean on PSMA PET Predicts Lutetium-PSMA Therapy Success in mCRPC - Koichiro Kimura
PTEN Inactivity Signature Predicts Docetaxel Benefit in Advanced Prostate Cancer - Emily Grist
Exploring Immunotherapy Outcomes in Cisplatin-Ineligible Bladder Cancer - Michiel Van Der Heijden
SSANTROP Trial: Evaluating Sasanlimab Plus Sacituzumab Govitecan in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer - Joaquim Bellmunt
Fracture Incidence Patterns Among Advanced Prostate Cancer Patients Receiving Androgen Receptor Pathway Inhibitors - Grace Lu-Yao
Neoadjuvant Niraparib in High-Risk Localized Prostate Cancer with DNA Repair Gene Alterations - Marc Dall'Era
Racial Disparities in Prostate Cancer Genomics and PARPi Treatment Outcomes - Sharon Choi & Qian Qin
DLL3-Targeted Theranostics for Neuroendocrine Prostate Cancer - Salomon Tendler
Uncovering Blood Mutation Risks in Advanced Prostate Cancer Therapies - Asli Munzur
Survey Uncovers Evolving Trends in Advanced Bladder Cancer Care - Ali Raza Khaki
Tumor Characteristics and Response Patterns in the ENVISION UGN-102 Trial - John Sfakianos
ENZA-p Trial: PSMA PET Guides Treatment Choice for Metastatic Prostate Cancer - Louise Emmett
Real-World Prostate Cancer Treatment Patterns in Colombia - Ray Manneh Kopp
ODYSSEY Study Reveals Real-World Quality of Life in Metastatic Kidney Cancer Patients - Michael Harrison & Benjamin Maughan
ORACLE Study Explores Efficacy of Post-Combination Therapies in Non-Clear Cell RCC - Deepak Kilari
Androgen Receptor Mutations in Prostate Cancer: Impact on Enzalutamide Response - Matthew Siskin
TRIPLE-SWITCH Trial Tests Docetaxel Addition for mHSPC Patients with Suboptimal PSA Response - Alexandra Sokolova
Tazemetostat + Talazoparib for Metastatic Castration-Resistant Prostate Cancer - Atish Choudhury
PSMA PET in Biochemical Recurrence: When to Treat vs When to Wait - Ravi Madan
MRI Radiomics Predicts Bladder Cancer Response to Pembrolizumab in PURE-01 Study - Andrea Necchi
Talazoparib-Enzalutamide Combintation and Quality of Life in mCRPC Patients - Nobuaki Matsubara
Emerging Prognostic Value of Molecular Imaging in Prostate Oncology - Wolfgang Fendler
CheckMate 214 Final Overall Survival Data: Long-Term Survival Benefits of Ipi/Nivo in Kidney Cancer - Michael Serzan
Metabolic Drugs and Prostate Cancer: Analyzing GLP-1 Agonist Use in Patients - Amy Shaver
Pediatric-Inspired Trial Tests IO-TKI Combo for Translocation Renal Cell Carcinoma - James Geller
Exploring IGF-1 Pathway Biomarkers and Outcomes in Metastatic Hormone-Sensitive Prostate Cancer - Lisa Horvath
One-Button PSMA PET Quantification Predicts Survival in Metastatic Prostate Cancer - Louise Emmett
Delayed Genomic Testing Limits Access to Life-Prolonging Cancer Treatments - Chadi Hage Chehade
CLONEVO Study: Targeting Cyclin D1 Amplifications in Bladder Cancer with Abemaciclib - Bishoy Faltas
Lutetium-177 Outperforms Cabazitaxel in mCRPC: Real-World Flatiron Database Analysis - Zeynep Irem Ozay
Evolving First-Line and Maintenance Strategies in Urothelial Cancer: Insights from ASCO 2025 - Jacqueline Brown
Terbium-161 vs Lutetium-177: Comparing Next-Gen Radioligands for Prostate Cancer - Michael Hofman
EZH2 Inhibition in Prostate Cancer: MEVPRO-1 Phase III Trial Update - Neeraj Agarwal
Racial Disparities in mCRPC Treatment: Equal Outcomes with Equal Access to Care - Stephen Freedland
PSMA DC Trial: Lutetium + SBRT to Delay ADT in Oligometastatic Prostate Cancer - Oliver Sartor
B7-H3 Targeting ADC in Castrate-Resistant Prostate Cancer Trial - Andrew Parsonson
Belzutifan Demonstrates Durable Activity in VHL Disease Tumors - Vivek Narayan
CONTACT-03 Subset Analysis: Similar Cabozantinib Response Across IO Pretreatment Types - Cristina Suárez
PSMA PET Scans Predict Enzalutamide Efficacy in Metastatic Prostate Cancer - Louise Emmett
AMPLITUDE Trial: Niraparib Delays Progression in HRR-Mutant Prostate Cancer - Gerhardt Attard
EV-302 Data: High CR Rates and Long-Term Survival with EV-Pembro - Shilpa Gupta
SURE-02 Trial: A Patient-Driven, Bladder-Sparing Approach for MIBC - Andrea Necchi
EMBARK Subgroup Analysis: Enzalutamide Monotherapy Effective Regardless of Prior Definitive Therapy - Stephen Freedland
Adjuvant Pembrolizumab Shows Sustained Survival Benefit in Renal Cell Carcinoma at 5 Years - Naomi Balzer-Haas
STELLAR-002 Trial: Zanzalintinib Combo Explored in Clear Cell RCC - Jad Chahoud
SASAN-SPARING Trial: Bladder-Sparing Approach for Muscle-Invasive Bladder Cancer - Elena Sevillano
Darolutamide Improves Outcomes in Metastatic Hormone-Sensitive Prostate Cancer Without Chemotherapy - Fred Saad
AI Model Identifies STAMPEDE Patients Needing Treatment Intensification - Nicholas James
Multimodal AI Test Predicts Prostate Cancer Metastasis and Treatment Response - Timothy Showalter
Genomic and Clinical Profiles of Rapidly Progressing mCRPC Patients - Maha Hussain
Phase I Trial Combines ONC-392 with Lutetium-177 for Prostate Cancer - David Wise
PDIGREE Trial Tests Adaptive Immunotherapy Approach for Metastatic Kidney Cancer - Tian Zhang
Complete Response in Low-Grade UTUC with Padeliporfin Therapy in the ENLIGHTED Trial - Vitaly Margulis
LUNAR Trial: Neoadjuvant Lutetium-PSMA Plus SBRT Evaluated in Oligometastatic Prostate Cancer - Amar Kishan & Jeremie Calais
Rectal Spacer Use Leads to Better Patient-Reported Bowel and Sexual Outcomes - Daniel Song
Analysis of ctDNA After Trimodal Therapy for Muscle-Invasive Bladder Cancer - Dekuang Zhao
Patient-Reported Outcomes in the NRG-GU005 Prostate Cancer Trial - James Yu
Neoadjuvant Pembrolizumab and Radiotherapy for Kidney Cancer - Muhammad Ali
Ten-Year Outcomes of the PCS5 Trial for High-Risk Prostate Cancer Presented - Tamim Niazi
Adjuvant Radiotherapy Evaluated for High-Risk Bladder Cancer After Cystectomy - Vedang Murthy
Analysis of Genomic Drivers of Discordant Risk Classifications in Prostate Cancer - Michael Zelefsky
NRG-GU006 Trial for Post-Prostatectomy Radiation Therapy - Daniel Spratt
Phase 2 EXTEND Trial of Metastasis-Directed Therapy with Continuous Hormone Therapy - Alexander Sherry & Bilal Siddiqui
Validating the APUC-6 Signature in mHSPC from the ECOG-ACRIN E3805 CHAARTED Trial - Xiaolei Shi
NRG-GU005 Trial Compares SBRT and Hypofractionated IMRT for Prostate Cancer - Rodney Ellis
Phase II LUNAR Trial Results: Adding Lutetium PSMA to SBRT for Oligorecurrent Prostate Cancer - Amar Kishan
Reimbursement RVU and Physician Surveys in Urology - Kyle Richards
Analysis of Restructured Grant Evaluation Processes at the NIH - Samuel Washington
Analysis of ctDNA in IMvigor011 Informs Adjuvant Therapy Decisions for Muscle-Invasive Bladder Cancer - Matthew Galsky
Navigating Treatment Options and Trial Designs for Intermediate-Risk Non-Muscle Invasive Bladder Cancer - Vignesh Packiam
CISTO Study: Patient Preferences Drive Bladder Cancer Treatment Choice, Shaping Quality of Life Outcomes - Angela Smith
SunRISe-1 Cohort 4 Analysis: One-Year Disease-Free Survival in BCG-Unresponsive Papillary Bladder Cancer - Siamak Daneshmand
SUO 2025 Session Highlights: Refined Hematuria Guidelines and Expanding Bladder Cancer Trial Landscape - Woodson Smelser
CORE-008 Cohort A First Results on Cretostimogene Grenadenorepvec for BCG-Naive Bladder Cancer - Shane Pearce
Design and Safety of a Patient-Centric Expanded Access Program with Cretostimogene Grenadenorepvec - Sarah Psutka
Subgroup Findings from CREST Trial in High-Risk Bladder Cancer - Gary Steinberg
KEYNOTE-905 Evaluates Perioperative EV+Pembrolizumab in Cisplatin-Ineligible Bladder Cancer - Hristos Kaimakliotis
Phase 1 Study Evaluates Bone Metastasis Resolution with SYNC-T Therapy SV-102 - Gerald Andriole
Coronary Atherosclerosis Findings from the REVELUTION Trial of Leuprolide and Relugolix - Avirup Guha & Sagar Patel
Cohort P Data from the BOND-003 Study in BCG-Unresponsive Papillary Bladder Cancer - Mark Tyson
ZIRCON-X: CAIX PET Imaging and Its Role in Biopsy, Surgery, and Care Planning for Indeterminate Renal Masses - Brian Shuch
24-Month Follow-Up Data from Phase 3 BOND-003 Cohort C Trial - Mark Tyson
CORE-008 Cohort B Investigates Cretostimogene Grenadenorepvec for BCG-Exposed High-Risk NMIBC - Trinity Bivalacqua
SUO 2025 Preview: Bladder Cancer Data from BCG-Unresponsive to Metastatic Disease - Patrick Hensley
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AUA 2026 Bladder Cancer

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AUA 2026 Upper Tract Urothelial Carcinoma

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Conference Coverage
Conference Highlights Written by Physician Scientists
Presented by Soichiro Yoshida, MD, PhD
The 2026 American Urologic Association (AUA) Annual Meeting featured an innovative presentation by Dr. Soichiro Yoshida evaluating the time-dependent overall survival benefit of enzalutamide plus radium-223 in men with metastatic castration-resistant prostate cancer (mCRPC) using reconstructed individual patient data (rIPD) from the EORTC 1333/PEACE-3 trial.
Presented by Michael Morris, MD
The 2026 PSMA & Beyond conference featured a clinical trial updates session and presentation by Dr. Michael Morris discussing DORA and PEACE-3 and the evolving role of radium-223.
Presented by Murilo de Almeida Luz, MD
The 2026 SESAUA annual meeting featured a prostate cancer session and presentation by Dr. Murilo de Almeida Luz discussing PSA and alkaline phosphatase decline in the EORTC PEACE-3 study evaluating the addition of radium-223 in metastatic castration resistant prostate cancer (mCRPC) starting enzalutamide.
Presented by Wei Chen, MD, MMed
The 2026 European Association of Urology (EAU) annual meeting featured an advancement in metastatic castration resistant prostate cancer (mCRPC) therapy session and a presentation by Dr. Wei Chen discussing a reconstructed analysis of the PEACE-3 trial assessing the time-dependent survival benefit of enzalutamide + radium-223 in mCRPC.
Presented by Enrique Gallardo, MD
 The 2026 GU ASCO annual meeting featured a prostate cancer session and a presentation by Dr. Enrique Gallardo discussing the final overall survival results from the EORTC 1333/PEACE-3 trial assessing enzalutamide with or without radium-223 in metastatic castration resistant prostate cancer (mCRPC).
Presented by Murilo de Almeida Luz, MD
The 2025 Western Section AUA annual meeting featured a prostate cancer session and a presentation by Murilo de Almeida Luz, MD, discussing the impact of bone-protecting agents on outcomes with enzalutamide, with or without radium-223, in asymptomatic/mildly symptomatic patients with bone mCRPC from PEACE-3. PEACE-3 was an ethics-approved international study in 446 patients with mCRPC and bone metastases randomized 1:1 to a combination of enzalutamide + radium-223 versus enzalutamide alone1:
Presented by Ronan Flippot, MD, MSc
Ronan Flippot, MD, MSc, discussed GETUG-AFU 43–PEACE8, a combination of darolutamide and stereotactic body radiation therapy in patients with castration resistant prostate cancer (CRPC) and oligometastases on functional imaging.
Presented by Michael Cookson, MD, FACS, MMHC
Michael Cookson, MD, FACS, MMHC, discussed PEACE-III, assessing enzalutamide versus a combination of radium-223 and enzalutamide in asymptomatic/mildly symptomatic patients with bone metastatic castration-resistant prostate cancer (mCRPC).
Presented by Andrey Soares, MD
The 2025 ASCO annual meeting featured a prostate cancer session and a presentation by Andrey Soares, MD, discussing PSA and alkaline phosphatase changes in the EORTC-1333 PEACE-3 study evaluating the addition of six cycles of radium 223 in metastatic castration-resistant prostate cancer (mCRPC) starting enzalutamide.
Presented by Fred Saad, MD, FRCS
The 2025 EAU annual meeting featured a prostate cancer session and a presentation by Dr. Fred Saad discussing a subgroup analysis of the PEACE 3 phase III trial assessing the impact of bone protecting agents on the efficacy and safety of enzalutamide versus combination of radium-223 and enzalutamide in asymptomatic or mildly symptomatic patients with bone metastatic castration-resistant prostate cancer (mCRPC). PEACE-3 was an international study in 446 patients with mCRPC and bone metastases randomized 1:1 to combination of enzalutamide and radium-223 versus enzalutamide alone:
Presented by Silke Gillessen Sommer, MD
(UroToday.com) The 2024 European Society for Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain between September 13th and 16th, 2024 was host to a presidential symposium of practice-changing trials. Professor Silke Gillessen presented the initial results of EORTC-GUCG 1333/PEACE-3

Bayer will present new oncology data, including a late-breaking, comprehensive analysis from the Phase III ARANOTE trial investigating NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC), at the European Society for Medical Oncology (ESMO) Congress, taking place in Barcelona, Spain, from September 13-17, 2024.

Presented by Oliver Sartor, MD
The 2024 PSMA conference featured a presentation by Dr. Oliver Sartor discussing the role of radium-223 in the setting of PSMA PET. Dr. Sartor started by highlighting that based on the ALSYMPCA trial published in 2013,1 this was the first alpha emitter approved in all of medicine.
Presented by Silke Gillessen, MD
Bone strengthening agents such as bisphosphonates or the RANKL-targeting antibody denosumab reduced the bone loss associated with androgen deprivation therapy (ADT) and prevent skeletal-related events in castration resistant prostate cancer (CRPC). The use of these agents is recommended in CRPC by many guidelines.
Presented by Silke Gillessen, MD
Beginning with the introduction of docetaxel for metastatic castration resistant prostate cancer (mCRPC) in 2004, there has been a dramatic and rapid proliferation of systemic therapy options in advanced prostate cancer including a number of novel hormonal therapies (including abiraterone acetate and enzalutamide),
Presented by Bertrand F. Tombal, MD, PhD
Skeletal fractures, pathological or not, are a frequent and underestimated side-effect of systemic treatment of metastatic castration-resistant prostate cancer (mCRPC). The ERA223 trial randomized 806 patients with chemotherapy-naïve, mCRPC with bone metastasis to radium-223 or placebo, in addition to abiraterone acetate.
Presented by Bertrand Tombal, MD, PhD
Dr. Bertrand Tombal and colleagues presented the trial design for PEACE III, enzalutamide vs. a combination of radium-223 (Ra-223) and enzalutamide in asymptomatic or mildly symptomatic CRPC patients metastatic to bone. The α-emitting radiopharmaceutical Ra-223 reduced the risk of death by 30% vs placebo in the phase III ALSYMPCA trial.1

Calendar

Upcoming Events
June 25-26, 2026
San Sebastián International Genitourinary Cancer Summit 2026
The Summit is an independent international educational meeting focused on multidisciplinary management of bladder, kidney, and prostate cancers, featuring leading faculty from Europe and internationally.

Location: San Sebastián, Spain
at the Hotel Monte Igueldo
Urology - General Add to calendar Conference website
June 27-29, 2026
2026 Annual Meeting of the Canadian Urological Association (CUA)
An essential forum for the exchange of cutting-edge knowledge, clinical advancements, and collaborative dialogue. It is a unique opportunity for colleagues to network, reconnect, and collectively advance the field of urology.

Location: Saskatoon, Canada
at TCU Place
Urology - General Add to calendar Conference website
July 29-31, 2026
Bladder Cancer Advocacy Network (BCAN) Think Tank 2026
The annual BCAN Bladder Cancer Think Tank Meeting is the premier annual bladder cancer-specific medical meeting in North America. Since its inception in 2006, the Think Tank meeting has focused on identifying obstacles and creating solutions in bladder cancer research, and has fostered discussions to help define priorities for advancing bladder cancer research. Invited participants include urologists, oncologists, researchers, pathologists, social scientists, patient advocates and industry representatives, all who are dedicated to improving the diagnosis and treatment of bladder cancer.

Think Tank supports new ideas and collaboration among participants from the medical, research and patient communities. The goal of the Think Tank is to accelerate progress in improving the diagnosis, treatment and quality of life for people impacted by bladder cancer.

Location: Denver, Colorado
at the Downtown Denver Hyatt Regency.
Urology - General Add to calendar Conference website
August 27-30, 2026
Integration of Functional Reconstructive Urology with Endourology (IFRUE) Meeting
This dynamic program, carefully developed in collaboration with leading societies (SoBPD, AACU, SWIU, NARUS, LUGPA), ensures diverse perspectives and state-of-the-art content. Beyond the core clinical challenges, the conference will explore innovation, effective practice management, and navigating the modern medical landscape.

IFRUE is purposefully designed to combine reconstructive fundamentals with cutting-edge, minimally invasive approaches. Dive deep into comprehensive strategies for managing challenging cases – from BPH and incontinence (male/female) to sexual medicine prosthetics, urethral strictures, neuromodulation, and robotics.

Location: Denver, CO
Urology - General Add to calendar Conference website
August 30-September 5, 2026
New York Section of the AUA 122nd Annual Meeting
The New York Section of the AUA's 122nd Annual Meeting.

Location: Rome, Italy
at The St. Regis Rome
Urology - General Add to calendar Conference website
September 9-12, 2026
South-Central Section of the AUA 105th Annual Meeting
The South-Central Section of the AUA's 105th Annual Meeting


Location: Tucson, AZ
at the JW Marriott Tucson Starr Pass Resort & Spa
Urology - General Add to calendar Conference website
The following section provides broader disease-state context and emerging research across high-risk NMIBC.
Content below is educational and investigational.

Videos
Clinical Conversations by Experts

Conference Coverage
Conference Highlights Written by Physician Scientists
Presented by Sima Porten, MD, MPH
At the 2025 AUA Annual Meeting, Dr. Sima Porten presented SunRISe-5, a phase III, randomized, open-label study comparing TAR-200 to intravesical chemotherapy after bacillus Calmette-Guérin (BCG) in recurrent, high-risk (HR), non–muscle-invasive bladder cancer (NMIBC).
Presented by Sima Porten, MD, MPH
At the 2024 Society of Urologic Oncology (SUO) annual meeting, Dr. Sima Porten presented SunRISe-5, a phase III randomized, open-label study of TAR-200 compared with intravesical chemotherapy after bacillus Calmette-Guerin (BCG) in recurrent, high-risk, non-muscle invasive bladder cancer (NMIBC).
Presented by James W.F. Catto
The 2024 European Association of Urology (EAU) annual meeting featured a session on non-muscle invasive bladder cancer, and a presentation by Dr. James Catto discussing the trial design of SunRISe-3, assessing TAR-200 plus cetrelimab or TAR-200 versus intravesical BCG in patients with BCG-naive high-risk non–muscle-invasive bladder cancer.
Presented by Andrea Necchi, MD
During the 2023 ESMO annual meeting, Dr. Andrea Necchi presented the study framework for SunRISe-3, a phase 3 randomized trial of TAR-200 plus cetrelimab or TAR-200 monotherapy versus intravesical BCG in patients with BCG-naïve, high-risk, non-muscle invasive bladder cancer (NMIBC).

American Urological Association (AUA) Annual Meeting - Archive

The American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) - Archive

European Association of Urology (EAU) Annual Congress - Archive

Society of Urologic Oncology (SUO) Annual Meeting - Archive

European Society for Medical Oncology (ESMO) Congress - Archive

International Bladder Cancer Group (IBCN) Meetings - Archive

Bladder Cancer Advocacy Network (BCAN) Think Tank - Archive

American Society of Clinical Oncology (ASCO) Annual Meeting - Archive

PSMA & Beyond Conference - Archive

Jamie Landman, MD