Wappingers Falls

Researchers are studying treatment options for Veterans with castrate-sensitive prostate cancer, a type of metastatic prostate cancer. This phase 2 randomized trial compares three drugs abiraterone acetate, enzalutamide, and apalutamide, to explore their effects on tumor growth and testosterone levels over two years. The study aims to build on previous findings showing uniform and high-quality care for Veterans in the Veterans Health Administration system, focusing on personalized treatment approaches and molecular differences among participants. Participants receive one of the three oral drugs daily in combination with a gonadotropin-releasing hormone GnRH agonist or antagonist, unless they have had prior surgical castration. The abiraterone acetate group may receive either YONSA or ZYTIGA formulations with corticosteroids, while the enzalutamide and apalutamide groups take their respective tablets once daily. Treatment continues as per the study protocol with careful monitoring. During the study, participants will undergo regular assessments including measuring tumor growth rate, testosterone levels, and prostate-specific antigen PSA response over two years. Safety labs like liver and kidney function tests, blood counts, and potassium levels will be monitored. The study evaluates how these treatments affect prostate cancer progression and hormone levels, with follow-up until study completion at the end of 2027.

Researchers are conducting a multi-center study to create a clinical plasma repository and evaluate an artificial intelligence-based in vitro diagnostic software called ExoPred. This software analyzes surface-enhanced Raman spectroscopy SERS profiles of extracellular vesicles from human plasma to support early detection of multiple cancers including lung, breast, colorectal, pancreatic, and ovarian cancers. The study aims to develop, assess, and validate this diagnostic tool through a structured multi-phase process. The study includes three phases Phase 1 involves analyzing at least 500 samples to train the algorithm and set initial clinical cut-off values, followed by a database lock. Phase 2 tests a minimum of 50 new unknown samples to evaluate model robustness before the final algorithm is locked. Phase 3 is a blinded independent stage where at least 200 independent samples, excluded from prior phases, are tested to evaluate clinical sensitivity, specificity, and accuracy. All data is managed under strict quality procedures and regulatory compliance. Participants provide blood samples before any systemic or definitive cancer treatment. The study collects and analyzes these samples over up to 36 months to measure sufficient sample testing and diagnostic performance. Data handling follows standard operating procedures within a compliant electronic data capture system. Participants are assessed for eligibility based on cancer diagnosis and treatment history, with safety and data integrity monitored throughout the study duration.