Erode

Researchers are evaluating the safety of darolutamide combined with standard androgen deprivation therapy (ADT) in Indian men who have high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). This type of prostate cancer does not spread to other parts of the body but progresses despite very low levels of male hormones called androgens. The study focuses on men whose prostate-specific antigen (PSA) levels rise quickly, indicating potential tumor growth. Darolutamide works by blocking androgens from attaching to cancer cell proteins, and this study aims to learn about its safety in Indian participants, comparing results to a previous study that did not include Indian patients. All participants will take darolutamide tablets orally twice daily, with a total daily dose of 1200 mg. They will continue standard ADT, which lowers androgen levels. Participants will visit the study center every 16 weeks until their cancer worsens, medical issues develop, they leave the study, or the study ends. If the trial stops, participants may continue darolutamide if it benefits them. During the study, researchers will collect blood and urine samples, perform physical exams, check vital signs, assess heart health with ECG, and evaluate daily living abilities using ECOG performance status. They will monitor medical problems called adverse events (AEs), including lab test results, physical findings, heart function, vital signs, and changes in daily living abilities over about 15 months. These safety and effectiveness results will help understand how darolutamide works in real-world conditions for this group.