Phase III Study of Acetylsalicylic Acid and Atorvastatin Added to Standard Treatment for Men With Castrate-Resistant Prostate Cancer

What this Trial Is About

Researchers are studying the effects of acetylsalicylic acid and atorvastatin on overall survival in patients with castrate-resistant prostate cancer CRPC who are starting first-line treatment. This international, open, phase III trial uses a 2x2 factorial randomized design to evaluate these drugs in addition to the standard care for CRPC. The study aims to understand whether adding these medications can improve survival outcomes for this patient group. Participants are randomly assigned to one of four groups standard of care alone, standard of care plus acetylsalicylic acid 100 mg daily, standard of care plus atorvastatin 80 mg daily, or standard of care plus both acetylsalicylic acid and atorvastatin. These treatments are taken daily alongside the usual care for their cancer. The trial monitors patients over up to 15 years to assess the long-term impact on survival. During the study, participants will be regularly evaluated for overall survival, which is calculated from the date of randomization until death. Researchers will also monitor patients for safety and adherence to the treatments. The trial includes detailed eligibility screening, performance status assessments, and laboratory tests to ensure patients meet the criteria to participate safely. The long follow-up period allows for comprehensive observation of treatment effects and patient outcomes.

Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer