Sumter County

Researchers are evaluating the safety and effectiveness of cretostimogene grenadenorepvec in adults with high-risk non-muscle-invasive bladder cancer (NMIBC) in this Phase 2, open-label study. The study includes multiple groups based on prior Bacillus Calmette-Guerin (BCG) treatment status: BCG-nave, BCG-exposed, and BCG-unresponsive or exposed. It aims to assess disease control and response in these different patient groups using cretostimogene alone or combined with gemcitabine. Participants are assigned to various cohorts and arms depending on their NMIBC subtype and treatment history. Treatment involves weekly instillations of cretostimogene for six weeks, with a possible reinduction course at 3 months if high-grade disease remains. Maintenance therapy follows with three weekly treatments every three months in the first year and every six months during the second and optional third years. Cohort CX participants receive cretostimogene plus gemcitabine either concurrently or sequentially. Throughout the study, participants undergo regular evaluations including urine cytology, cystoscopy, upper urinary tract assessment, and biopsies if needed every 3 months for 2 years, then every 6 months for an additional 2 years or until disease returns. The main outcomes measured include complete response rates at 11 and 24 weeks and event-free survival over 48 months, with ongoing safety monitoring during this period.

Researchers are evaluating the clinical outcomes of the Axonics Sacral Neuromodulation (SNM) System for treating overactive bladder (OAB) in male patients. The study focuses on men who have previously undergone radical prostatectomy, radiation for prostate cancer, or surgical intervention for benign prostatic hyperplasia (BPH). The goal is to assess the device's safety and effectiveness in reducing urinary urgency incontinence (UUI) and urinary frequency (UF) episodes. Participants will receive treatment with the Axonics SNM System, a device designed to manage symptoms of overactive bladder. The study monitors patients over a period of up to one year following device implantation. No comparator group is mentioned, as the focus is on post-market clinical outcomes of this device in the specified male population. During the study, participants will complete bladder diaries and patient questionnaires to track symptoms and treatment effects. Researchers will monitor adverse events and measure reductions in UUI and UF episodes at 6 months and 1 year after treatment. Follow-up assessments will ensure ongoing evaluation of safety and performance throughout the study duration.

Bladder cancer is one of the most common malignancy worldwide, and non-muscle invasive (NMIBC) requires intensive regimens of frequent monitoring and local resection (transurethral resection of bladder \[TURBT\]). This study enrolls participants with non-muscle invasive or muscle invasive bladder cancer with activating fibroblast growth factor receptor (FGFR) mutations or fusions. Erdafitinib is a pan-FGFR inhibitor with demonstrated clinical activity when administered orally in patients with solid tumors, including bladder cancer, with FGFR genetic alterations. The Erdafitinib intravesical delivery system is designed to provide release of Erdafitinib in the bladder to treat localized bladder cancer, while reducing systemic toxicities. The study consists of a screening phase, a treatment phase, and a follow-up phase. Total duration of the study is approximately up to 7 years 4 months.