Renal Retention in High Grade Upper Tract Urothelial Cancer
High Grade Urothelial CarcinomaBladder Cancer1 moreThis trial will evaluate the use of combination pembrolizumab and enfortumab vedotin for patients with high grade non-metastatic (cN0/NxMx, no measurable regional lymph nodes, no metastases) upper tract urothelial cancer (UTUC), preferring to forego standard of care radical nephroureterectomy (RNU) surgery. Currently these patients would not be suitable candidates for neoadjuvant trials, as the patients intention is to forego surgery. The patients are also not candidates for metastatic trials, as the patients have no measurable metastasis. The Investigators hypothesize the combination of pembrolizumab and enfortumab vedotin for patients with high grade cN0/NxMx UTUC deferring RNU will lead to event free survival outcomes similar to that achieved by RNU in a historic dataset.
A Proposed Tetra-modal Treatment Protocol for Muscle Invasive Urothelial Carcinoma of the Urinary...
Bladder CancerIn Egypt, bladder cancer has been the most common cancer during the past 50 years. In 2002, Egypt's world-standardized bladder cancer incidence was 37/ 100,000, representing approximately 30,000 new cases each year. About 25% of new diagnoses are muscle-invasive bladder cancer (MIBC), which carry a worse prognosis compared to non-muscle invasive disease. Neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) with bilateral pelvic lymphadenectomy is considered the standard of care for treatment of MIBC by multiple international guidelines. However, this is associated with a significant impact on quality of life. The effect of our proposed Tetra-modal treatment protocol for muscle invasive Urothelial carcinoma of the urinary bladder on muscle invasive bladder cancer recurrence free survival, cancer specific survival, and overall survival? Koga developed a selective bladder-sparing protocol with a tetra modal therapy comprising maximal transurethral resection of bladder tumor, induction chemoradiation (CRT), and consolidative partial cystectomy (PC) with pelvic lymph node dissection, allowing the confirmation of CRT response pathologically. In the preliminary analysis of the initial cases enrolled in their protocol, none of the patients who completed the protocol with consolidative PC experienced MIBC recurrence, suggesting that consolidative PC may improve local cancer control in the preserved bladder by surgically eliminating possible cancer remnants after CRT. Our proposed Tetra-modal treatment protocol for MIBC is supposed to eliminate the surgical difficulties of performing PC in a radiated field and hence decrease the post operative complications of PC.
ADSTILADRIN Early Utilization and Outcomes in the Real World Setting in the United States
Bladder CancerMulti-center, prospective non-interventional study to collect data on the early use of ADSTILADRIN in the US. Data will be collected from participants, caregivers and prescribing physicians in a real-world setting.
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid...
Advanced Malignant Solid NeoplasmBladder Carcinoma48 moreThis phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
Treatment of Metastatic Tumors of the Urogenital Area With Cytokine-induced Killer Cells
Bladder CancerRenal CancerTreatment of metastatic tumors of the urogenital area with cytokine-induced killer cells
Computed Tomography Urography (CTU) vs Intravenous Urography (IVU) on Patients at Risk of Urothelial...
Bladder CancerThe goal of this clinical research study is to use computed tomography urography (CTU) scans and intravenous urography (IVU) scans to check the status of urothelial cancer, in order to try to learn the level of effectiveness of possibly using CTU by itself in future patients.
Vesical Imaging-Reporting and Data System (VI-RADS) Followed by Photodynamic Trans-urethral Resection...
Non-muscle-invasive Bladder CancerNon-Muscle Invasive Bladder Urothelial Carcinoma1 moreBackground: In European Association of Urology (EAU) Guidelines, the vast majority of non-muscle-invasive bladder cancers (NMIBCs) undergo a primary transurethral resection of the bladder tumor (TURBT) followed by a repeat TURBT (Re-TURBT). The Re-TURBT is recommended due to the possibility of residual bladder cancer but is unnecessary in many cases by constituting overtreatment. Currently, no diagnostic strategy or predictive tools have been implemented to further stratify who does or does not benefit from Re-TURBT. Recently, an MRI-based Vesical Imaging Reporting and Data System (VI-RADS) score has been developed to stage as to the preoperative probability of muscle invasion, which could potentially exclude those who do not require a Re-TURBT when a primary high-quality resection is delivered. As such, performing TURBT with standard white light (WL) cystoscopy is known to miss many bladder tumours, which may be poorly visible, and a technique known as with photodynamic diagnosis (PDD) results in lower residual tumor and lower early intravesical recurrence rates. PDD is performed using violet light to improve the detection of these lesions not easily visible with WL cystoscopy. Methods/Aims: The investigators propose an Italian, single-center, phase IV, open-label, non-inferiority, randomized controlled trial, in which participants (n=112) who had already received a mpMRI/VI-RADS score, are randomized to receive PDD-TURBT, no Re-TURBT versus standard of care represented by conventional WL-TURBT followed by WL-Re-TURBT. The primary outcome is proportions of early recurrence in the urinary bladder. Secondary outcomes will include proportions of late BCa recurrence, late disease-free interval, time to progression to MIBC, patient's quality of life assessment, and cost-analysis. Perspective: The CUT-less trial aims to respond to this unmet need through a non-inferiority randomized clinical study potentially shaping the perspective for a paradigm shift towards a more personalized, socially, and economically sustainable updated NMIBC therapeutic pathway. Implications: The current clinical trial proposal is aiming to achieve a paradigm shift in the oncological and socio-economical management of urothelial malignancies of the urinary bladder. Our first concern is indeed to guarantee a safe and ground-breaking strategy to manage the pathway of such patients in order to guarantee the non-inferior oncologic safety (and possibly superiority) when compared to the current standard of care. Additionally, if our hypotheses are confirmed, the investigators will be able to significantly relieve these patients from the oncologic burden of an already invasive and arduous bladder cancer care path. Finally, safely avoiding an unnecessary, expensive surgical procedure will bring significant social and economic benefits to the EU healthcare system and possibly worldwide.
Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors
Adenocarcinoma of the BladderSquamous Cell Carcinoma of the Bladder1 moreBackground: Many cancers of the testicles and urinary tract are rare diseases; these are diseases that affect less than 200,000 people in the United States. It can be hard to study treatments for these diseases. One combination of drugs-enfortumab vedotin (EV) and pembrolizumab-has already been approved to treat some urinary cancers. Researchers want to see if they can help people with other types of testicle and urinary cancers. Objective: To test EV, with or without pembrolizumab, in patients with rarer cancers of the testicles or urinary tract. Eligibility: People aged 18 and older with rarer cancers of the testicles or urinary tract. Design: Participants will be screened. They will have a physical exam with blood and urine tests. Their ability to perform normal daily activities will be tested. They will have exams of their skin and eyes. They will have imaging scans. A biopsy may be needed: A sample of tissue will be removed from the tumor. The study drugs are both given through a tube attached to a needle inserted into a vein in the arm. Some participants will receive treatments 3 times during 28-week cycles; others will receive treatments 2 times during 21-day cycles. All participants may continue to receive treatments for up to 5 years. Imaging scans and other tests will be repeated. Participants who stop taking the drugs will have follow-up visits every 3 to 4 weeks until the disease gets worse. They will have imaging scans and blood tests. After that, follow-up visits will continue by phone every 3 months for up to 5 years after study therapy is finished.
Deep Learning Radiomics Model for Predicting Post-cystectomy Outcome in Muscle Invasive Bladder...
Bladder CancerMuscle invasive bladder cancer (MIBC) has a poor prognosis even after radical cystectomy. Postoperative survival stratification based on radiomics and deep learning may be useful for treatment decisions to improve prognosis. This study was aimed to develop and validate a deep learning radiomics model based on preoperative enhanced CT to predict postoperative survival in MIBC.
Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy
Bladder CancerThe purpose of this clinical trial is to determine if prostate-capsule-sparing cystectomy improves functional outcomes without comprising oncologic outcomes in male patients receiving a radical cystectomy. Patients will be randomized to one of two groups: prostate capsule-sparing radical cystectomy or nerve-sparing radical cystectomy. Patients will be monitored following standard of care guidelines and clinical data will be collected. Patients in both groups will be asked to complete an erectile function questionnaire at multiple timepoints. Patients who receive an orthotopic neobladder will be asked to complete a questionnaire to monitor urinary function at multiple timepoints. Patient adverse events will be monitored to ensure patients safety.