Ureteral Cancer

Researchers are studying men with metastatic castration-resistant prostate cancer (mCRPC) to understand how different PET/CT scans can predict outcomes during radioligand therapy with 177Lu-PSMA-617. This is an exploratory, prospective study conducted at a single center, focusing on imaging tumor heterogeneity to help assess therapy effects and patient response. The study is designed specifically for Veterans undergoing this treatment. Participants will receive several types of PET/CT scans at different times: before starting LuPSMA radioligand therapy (RLT), and then after the 2nd, 4th, and 6th treatment cycles. These scans include 18F-Fluciclovine PET/CT (Axumin), 18F-DCFPyL PET/CT, and 18F-FDG PET/CT. The 18F-Fluciclovine scans will be performed within seven days of the PSMA PET scans to compare imaging results at each time point. During the study, detailed imaging measures such as lesion uptake and tumor volume will be collected and analyzed over time. Patients will be followed at the institution to correlate these imaging results with clinical outcomes. The main outcome measured is the impact of 18F-Fluciclovine PET/CT on predicting outcomes of the 177Lu-PSMA-617 therapy from enrollment through 34 weeks of treatment.

Researchers are evaluating the effectiveness of combining 9MW2821 with toripalimab compared to using 9MW2821 alone in patients with locally advanced or metastatic urothelial carcinoma who have not yet received systemic treatment for their advanced cancer. This randomized phase II trial aims to improve first-line treatment options for this condition, which includes urothelial carcinoma of the bladder, renal pelvis, and ureter. Participants will be assigned to receive either the combination of 9MW2821, a nectin-4 antibody-drug conjugate with MMAE payload, plus toripalimab, an anti-PD-1 antibody, or 9MW2821 monotherapy. The study treatments will be given according to protocol, with no masking or blinding. The trial includes a planned 3-year period to assess treatment response and safety. Throughout the study, participants will undergo regular assessments including evaluations of tumor response using RECIST v1.1 criteria, safety monitoring, and immunogenicity tests over three years. Researchers will measure outcomes such as the objective response rate and other efficacy endpoints. Participants must be able to follow study visits, treatment, and laboratory procedures, with contraceptive measures maintained until 180 days after the last dose. The overall participation spans from screening through treatment and follow-up over the study duration.

Researchers are evaluating the safety and effectiveness of combining the drugs 9MW2821 and Toripalimab in patients with urothelial cancer who are undergoing surgery. This phase II clinical trial is open-label and involves multiple centers. The study focuses on patients with confirmed non-metastatic urothelial cancer, including muscle-invasive bladder cancer (MIBC) and high-risk upper tract urothelial carcinoma (UTUC). Participants receive intravenous infusions of 9MW2821 at a dose of 1.25 mg/kg and Toripalimab at 240 mg. The study includes three groups based on cancer type and risk: Arm 1 with MIBC, Arm 2 with high-risk UTUC, and Arm 3 with MIBC. The study is not randomized, and all participants receive the experimental treatment combination. During the study, participants will be monitored for up to 24 months to assess outcomes such as pathological complete response (pCR), clinical complete response (cCR), overall response rate, disease-free survival, progression-free survival, overall survival, and safety events. Researchers will also evaluate immunogenicity and expression of biomarkers Nectin-4 and PD-L1. Regular assessments include tumor tissue testing and organ function monitoring to ensure participant safety and treatment adherence.

Researchers are evaluating the effectiveness, safety, and immune response of a combination treatment of 9MW2821 and Toripalimab compared to standard chemotherapy for adults with locally advanced or metastatic urothelial cancer who have not had prior systemic treatment. This phase 3 randomized, controlled, open-label study involves multiple centers and aims to provide new options for this serious condition. Participants will be randomly assigned to receive either the experimental combination of 9MW2821 at 1.25 mg/kg and Toripalimab at 240 mg, both given by intravenous infusion, or standard chemotherapy consisting of Gemcitabine with either Cisplatin or Carboplatin, also given by intravenous infusion. The study includes two treatment groups and is designed to compare these approaches as first-line therapy. During the study, participants will undergo regular assessments including imaging to measure tumor response using criteria up to 50 months, overall survival tracking, and evaluations of side effects and immune responses. Researchers will monitor progression-free survival and other outcomes, along with safety and tolerability. Follow-up visits and evaluations will be conducted throughout the study period to gather comprehensive data on the treatments' impact and participant health.

This research investigates the safety and effectiveness of disitamab vedotin combined with radiotherapy for patients with upper urinary tract urothelial carcinoma (UTUC) who have high-risk factors for recurrence after radical surgery. The study involves 60 patients with HER2 overexpression and aims to evaluate disease-free survival and other outcomes over time. Patients are grouped based on their choice to receive adjuvant therapy or to undergo close observation with supportive care. Patients in the adjuvant therapy group receive disitamab vedotin, a targeted drug, alongside radiotherapy. The radiotherapy dose targets lymph node areas and metastatic sites over a 5-week period. The disitamab vedotin treatment lasts for 6 months. Those in the non-adjuvant group do not receive this therapy but are closely monitored. Safety and effectiveness assessments continue throughout the study, including follow-up after treatment completion. Participants will have regular safety checks before each treatment dose and for 30 days after the last dose or new antitumor therapy starts. Tumor and health assessments occur every 12 weeks for about 2 years or until tumor recurrence or other study endpoints. If disease progresses, follow-up continues every 3 months to track survival and further treatments. The study collects data on overall survival, recurrence, tumor markers, physical status, and adverse events to understand the treatment impact and safety.

Upper Tract Urothelial Cancer (UTUC) is a relatively uncommon but increasingly diagnosed condition with many controversies and limitations in its management. Researchers aim to create a local registry at their hospital to gather detailed clinical information and outcomes related to UTUC, helping to better understand the disease's epidemiology, natural history, and treatment results. This study is observational and focuses on collecting comprehensive data to improve knowledge and care for UTUC patients. Participants in this study will be adults diagnosed with UTUC who are either awaiting surgery or have a history of UTUC with prior interventions. The study involves collecting blood, urine, and tumor tissue samples to explore new diagnostic and therapeutic possibilities. There is no specific treatment given as part of this study; rather, it tracks patients over time to assess the disease and its effects. Participants will be followed for up to 10 years to monitor long-term survival, recurrence rates, disease progression, and any complications related to UTUC. The study includes regular collection of clinical information and biological samples to support these assessments. This long-term observation aims to provide valuable insights into the physical and biological impact of UTUC on patients.

This research aims to study the benefits of a personalized home-based exercise program to improve physical function and surgical outcomes in patients with bladder cancer and upper tract urothelial carcinoma undergoing major surgery such as radical cystectomy or nephroureterectomy. The trial focuses on patients with these cancers who may also receive chemotherapy before surgery. Improving physical activity before surgery might help reduce inactivity and physical decline after the operation. Participants are randomly assigned to one of two groups. One group uses the ExerciseRx app to perform four 20-30 minute home exercise sessions per week, including core strength and balance exercises, along with personalized step goals, starting at least 4 weeks before surgery and continuing for 90 days after surgery. These patients also wear a FitBit and use its app. The other group receives standard educational materials and wears a FitBit with its app but does not follow the exercise program. Both groups may receive chemotherapy as part of their standard care before surgery. Throughout the study, patients are followed from enrollment through surgery and for 90 days afterward, totaling about 4 to 7 months. Researchers measure changes in physical function, frailty, body composition, patient-reported quality of life, and surgical outcomes such as length of hospital stay and complications. The study also tracks how well patients stick to the exercise program and their experience using the ExerciseRx app, with monitoring via FitBit devices and questionnaires. Surgical outcomes and safety are carefully observed during this period.

Researchers are studying tumors in the genitourinary (GU) tract, which includes cancers of the kidney, bladder, prostate, testicles, penis, and neuroendocrine cancers. Some of these tumors are rare and not well represented in treatment studies or tissue banks, making it difficult to establish standard care. This research aims to better understand both common and rare GU tumors by collecting detailed patient information over time. Participants in this long-term, multi-center observational study will provide medical history and may undergo physical exams, blood and urine sample collection, and surveys about family cancer history. Imaging scans of the chest, abdomen, and pelvis may be performed, sometimes with contrast injections. Patients may also provide existing tumor samples or optional biopsies. Samples may be used for genetic testing, and various scientific analyses including genomics and immune monitoring will be conducted. Throughout the study, participants will have regular follow-up visits and ongoing monitoring of their health, either at the research site or through coordination with their home doctors. Researchers will track disease patterns, treatment responses, and disease progression to characterize the natural history of GU cancers. This study will continue to follow patients over their lifetime to gather comprehensive data and improve future diagnosis and treatment strategies.

Researchers are collecting de-identified tumor samples along with clinical and demographic data from cancer patients who have had or are scheduled for a tumor biopsy before starting treatment with PD-1/PD-L1 inhibitors. The study aims to use these samples and information to develop and validate a diagnostic test that may help predict how patients respond to immunotherapy. This observational study involves multiple types of cancer including head and neck, lung, breast, and others. Participants are included if they have one of several specified cancers and have undergone or will undergo a tumor biopsy before beginning anti-PD-1/PD-L1 treatment. The study does not require extra biopsies beyond those collected as part of standard care. Patients must have had medical imaging of the tumor before treatment and provide consent for their tissue and data to be used in related future studies. The main diagnostic tool studied is the OncoPrism™ assay, which analyzes the immune components of tumor tissue. During the study, participants' tumor specimens and medical data are collected and de-identified to protect privacy. Researchers will review how patients respond to PD-1/PD-L1 inhibitors over six months. No additional treatments or procedures are required beyond standard care and consent. The study is sponsored by Cofactor Genomics, Inc., and participation involves tracking tumor biopsy samples and clinical outcomes over time until the study ends in February 2027.

Researchers are evaluating the Human Multigene Methylation Detection Kit (Fluorescent PCR Method) to help diagnose bladder cancer by comparing it with standard clinical methods such as medical imaging, cystoscopy, and pathological examination. The study includes participants diagnosed with or suspected of bladder cancer, those at high risk, or those with symptoms or other conditions that might be confused with bladder cancer. The goal is to assess the safety and effectiveness of this urine DNA testing kit. Participants will provide urine specimens for testing with the Human Multigene Methylation Detection Kit, and will also undergo examinations using the standard clinical methods. The study involves two groups of participants: one with bladder cancer and one without. Technical staff evaluating the urine test results will be blinded to the clinical diagnosis results. The study is observational and single-blinded. During the study, participants will provide urine samples and undergo medical imaging, cystoscopy, or pathological examination as needed. Researchers will compare the urinary test results with clinical findings to analyze sensitivity, specificity, consistency rate, and agreement (Kappa Coefficient) over one year. Participants' involvement includes specimen collection and standard diagnostic procedures, with safety and diagnosis effectiveness monitored throughout the study period.