Ureter Cancer

Researchers are studying men with metastatic castration-resistant prostate cancer mCRPC to understand how different PETCT 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 PETCT 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 PETCT Axumin, 18F-DCFPyL PETCT, and 18F-FDG PETCT. 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 PETCT 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 mgkg 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 mgkg 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 challenges in its management. Researchers aim to establish a local registry to comprehensively assess the physical and biological effects of UTUC in patients treated at their hospital. This registry will help gather detailed clinical information and outcomes related to UTUC management. Participants in this observational study will be patients with UTUC who are either awaiting surgery or have a history of UTUC with prior interventions. The study involves collecting clinical data and biological samples including blood, urine, and tumor tissue to support research into new diagnostic and therapeutic options for UTUC. During the study, participants health and disease progression will be tracked over a long-term period of up to 10 years. Researchers will monitor survival rates, recurrence, disease progression, and complications. This extended follow-up will help provide valuable insights into the epidemiology and natural history of UTUC, supporting improved patient care.

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, including cancers of the kidney, bladder, prostate, testicles, penis, and rare types such as neuroendocrine cancers. This study aims to better understand both common and rare urinary tract cancers, especially those so rare that they are not often included in treatment studies or tissue banks. The goal is to gather detailed information about the natural history and characteristics of these cancers to improve diagnosis and treatment. Participants will be part of a long-term, multi-center observational study where their medical histories will be collected and followed over time. They may provide tissue samples, blood, and urine for scientific studies, including genetic testing. Imaging scans of the chest, abdomen, and pelvis may be done, sometimes with contrast agents. Optional tumor biopsies may be performed up to twice a year to collect samples. Participants will receive recommendations about cancer management and treatment and can ask questions throughout the study. During the study, participants will have physical exams, provide clinical photographs of skin lesions, and complete surveys about family cancer history. Follow-up visits will occur frequently, and if participants cannot visit the study center, their home doctors will be contacted to continue monitoring. The study will track disease progression, treatment responses, and other clinical information over the participants lifetimes. The primary outcome measure is understanding the natural history of urothelial and rare genitourinary cancers.

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-1PD-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-1PD-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-1PD-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 conducting a multicenter, prospective observational study to monitor the recurrence of urothelial carcinoma, a type of urinary tract cancer. The study includes four patient groups those with high-risk upper tract urothelial carcinoma UTUC, patients with non-muscle invasive bladder cancer NMIBC, patients with muscle-invasive bladder cancer MIBC undergoing neoadjuvant therapy, and patients who have achieved complete response after trimodality therapy TMT and preserved their bladder. The goal is to evaluate the sensitivity and specificity of a urinary microscopic residual disease MRD score for detecting tumor recurrence or residual disease. Participants provide urine samples for MRD testing at specific times depending on their group before and after treatment cycles, or during regular postoperative reviews every six months up to one year. Imaging assessments are also used to confirm clinical status and disease presence, including evaluations before TMT or neoadjuvant therapy. The study observes patients undergoing standard treatments such as surgery, chemotherapy, and TMT without altering their care. During the study, patients undergo urine sample collection and imaging assessments at set intervals to monitor disease status. The MRD score is the main outcome measure, recorded at baseline and during treatment or follow-up visits. Researchers will analyze how well the MRD score predicts tumor recurrence, residual tumors, or metastases. The study lasts up to one year post-treatment with regular reviews and urinary testing, providing ongoing monitoring for participants while documenting their clinical outcomes.