Clinical Trials | 5541-CL-0201: A Phase 2, Open-label, Multi-cohort Study to Assess the Efficacy and Safety of ASP5541 in Participants with Advanced Prostate Cancer

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with advanced prostate cancer for a research study. The purpose of the study is to determine how investigational ASP5541 works in people with certain types of metastatic prostate cancer (prostate cancer that has spread to other parts of the body). The study also aims to assess: • The safety of ASP5541, • How it is absorbed by and cleared from the body, • How well it works against prostate cancer, • How ASP5541 works when it is given with a steroid, and • How ASP5541 works when it is given without a steroid. This study will consist of 4 periods: Screening (up to 28 days), Treatment, Safety Follow-ups 30 days and 90 days after last dose of ASP5541/ Abiraterone Acetate) and Long-term Follow-up (including survival follow-up). Participants who discontinue study treatment without radiographic progression will continue radiographic assessments every 12 weeks until radiographic progression. After the 90-day Safety Follow-up, participants will be contacted every 12 weeks thereafter to collect information on survival status and any additional subsequent prostate cancer treatment. Survival follow-up will continue until withdrawal of consent, death or the end of the study. We expect that your taking part in this research will last roughly 40 months but is dependent on how your body responds to treatment.