Oneida

Researchers are investigating how well standard systemic therapy alone or combined with definitive treatment (prostate removal surgery or radiation therapy) works in men with prostate cancer that has spread to other parts of the body. This phase III trial aims to compare overall survival and other outcomes such as progression-free survival and quality of life between these treatment approaches. The study also explores differences in urinary function, pain, and physical functioning reported by patients over time. Participants begin with an induction period of 22 to 28 weeks receiving one of six forms of standard systemic therapy, which may include hormonal treatments, chemotherapy with docetaxel, or other approved medications. After this period, they are randomly assigned to either continue standard systemic therapy alone or receive standard systemic therapy plus definitive treatment of the primary tumor through prostatectomy within 8 weeks or radiation therapy within 4 weeks. The treatments are given according to accepted schedules, such as subcutaneous or intramuscular injections, oral medications, or intravenous infusions. During the study, participants undergo various assessments including physical exams, lab tests for prostate-specific antigen and testosterone levels, imaging scans, and patient-reported quality of life questionnaires. Researchers follow participants for up to 8 years to measure overall survival and monitor disease progression, symptoms, and side effects. Tissue and blood samples may be collected for future research. The study also tracks urinary and physical function changes and pain levels at multiple time points after starting therapy.