Prevention and Management of Intravesical BCG-related Lower Urinary Tract Symptoms
Lower Urinary Tract SymptomsBladder Carcinoma1 moreCommon local side effects are generally seen during induction and during the first 6 months of BCG maintenance. BCG-related cystitis is frequent and unavoidable. Furthermore, repeated BCG instillation increases the incidence and severity of irritative bladder symptoms. Several methods attempted to reduce the intensity and frequency of BCG- related lower urinary tract symptoms (LUTS), such as, administration of anti-tuberculosis drug isoniazid or oral antibiotic ofloxacin or by reducing the BCG dose, but without any encouraging results. Local side effects requiring cessation of treatment are seen more frequently in the first year of therapy, preventing patients from receiving their BCG maintenance regimen. Pentosan Polysulphate (PPS), is an oral medication with unique analgesic properties used to relieve bladder pain and discomfort related to other conditions, has been investigated in a small study with encouraging result in this patient population. This suggest that PPS is well tolerated and effective at decreasing BCG-related LUTS. The purpose of this study is first to investigate the efficacy of co-administration of Pentosan Polysulphate to prevent these adverse events and the impact of this intervention on quality of life. The second goal is to determine which patients are more vulnerable to develop BCG- related lower urinary tract symptoms (LUTS), based on clinical assessment, demographics data, voiding parameters, and urinary inflammatory markers, and then to assess the effectiveness of BCG therapy following co-administration of ELMIRON.
Study Comparing Open Radical Cystectomy With Robot-assisted Cystectomy in Patients With Bladder...
Urinary Bladder NeoplasmsThe purpose of the study to compare two established methods of radical cystectomy (RC) in patients with bladder cancer. The participants will be treated under conditions in alignment with up-to-date guidelines and care. We wish to investigate whether it is feasible to compare the two methods under conditions of the highest methodological quality.
A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients...
Urinary Bladder NeoplasmNeoplasm MetastasisThe main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.
Study of APL-1202 in Non-Muscle Invasive Bladder Cancer Patients Who Are Resistant to One Induction...
Non-Muscle Invasive Bladder Cancer (NMIBC)A Phase Ib, open label, non randomized study to measure the safety and PK characteristics of APL-1202 at steady-state in adult male and female BCG resistant NMIBC patients when it is administered alone and concurrently with BCG.
Thulium Fiber Laser En-bloc Resection vs Conventional Transurethral Resection of Non-muscle-invasive...
Bladder CancerOngoing efforts aim at overcoming the challenges of conventional transurethral resection of bladder tumor (TURBT) such as the high recurrence rate, difficulty of pathologic interpretation and complications including wall injury. Possible advantages may have en bloc resection of bladder tumor which was previously shown to be effective and safe technique. Use of novel thulium-fiber laser may also provide additional safety and efficacy of the resection. Objective. To prospective assess the safety and efficacy of Thulium-fiber en bloc resection of bladder tumor (Tm-fiber-ERBT) compared to TURBT.
Durvalumab (MEDI4736) and TREmelimumab in NEOadjuvant Bladder Cancer Patients (DUTRENEO)
Bladder CancerIn the treatment of localized/locally advanced urothelial cancer, there are several questions that have not yet been resolved, such as the limited benefit of cisplatin-based chemotherapy in the adjuvant or neoadjuvant context, the difficulty in establishing which groups actually benefit from either perioperative treatment and what are the molecular markers that could help us predict the response to this treatment to allow a better selection of patients. On the other hand, not all patients are candidates for cisplatin-based chemotherapy and carboplatin is not comparable in activity, so there is an urgent need to find other drugs that may offer a therapeutic opportunity to these patients. In the context of metastatic disease, immunotherapy has been able to modify the natural history of this disease, administered as monotherapy, but the combination with double immune checkpoint inhibitors is also being evaluated with promising results. Even this therapeutic strategy is being advanced to the context of adjuvant and neoadjuvant treatment of urothelial tumors. In this sense, on the one hand, the present study, as a research in the neoadjuvant setting, constitutes the opportunity to define molecular phenotypes in bladder cancer since the design of this study will allow both, to evaluate the efficacy of the drug when the tumor is operable and to carry out an extensive analysis of biomarkers in the tumor tissue of these patients with an in-vivo evaluation of immune-based therapy activity. On the other hand, it allows to evaluate a strategy of double-immune checkpoint inhibitors that has already demonstrated activity in metastatic disease and, taking into account, the modest benefit of standard chemotherapy in the perioperative context: platinum-based neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer (MIBC) Modest increase in overall survival, but only a subset of eligible patients are eligible to receive it. In addition, radical cystectomy alone, in MIBC patients, presents a 5-year relapse rate of 10-50%.
A Study to Evaluate Treatment Preferences for Japanese Participants With Muscle-invasive Urothelial...
Urinary Bladder NeoplasmsThe main purpose of this study is to identify important treatment attributes for post-radical cystectomy (RC) treatment for participants with MIBC (Muscle-Invasive Bladder Cancer) and assess the relative importance of treatment attributes for post-RC treatment in Japan.
Clinical Performance Evaluation of the C2i Test
Muscle Invasive Bladder CancerThe overall objective of this study is to demonstrate the safety and effectiveness by means of investigation of the ability of C2i-Test to predict 2-year recurrence-free survival post-RC in stage II-IIIA MIBC patients.
Long-Term Outcomes of Robot-Assisted Radical Cystectomy: A Real-World Study
Bladder CancerRobot-assisted Radical CystectomyA multicenter, retrospective research was conducted. Patients who underwent robot-assisted radical cystectomy (RARC) from for bladder cancer in 32 institutions in China were enrolled in this study. Baseline condition, perioperative, pathological, and survival outcome were collected. The study was aimed to report the real-world condition of RARC in China, and evaluate its effectiveness.
Pilot Study to Evaluate the Clinical Response to Mitomycin-C in Hydrogel (TC-3) Administered Intravesically...
Urinary Bladder NeoplasmsUrologic Neoplasms3 moreThe purpose of this study is to evaluate the clinical response of the tumors within the bladder of recurrent NMIBC patients to Mitomycin-C embedded in UroGen Pharma's (known at that time as TheraCoat Ltd.) TC-3 Sterile Hydrogel (TC-3) and to evaluate the patency of ureters 6 hr post instillation.