This is a 2x2 factorial randomized, multicenter, international, open phase III trial.
The primary objective is to evaluate the benefit of acetylsalicylic acid and atorvastatin on overall survival (OS) (main endpoint) for patients with castrate-resistant prostate cancer starting first line treatment for CRPC
Histologically confirmed adenocarcinoma of the prostate and no curative local therapy considered possible
Age ≥ 18 years, life expectancy of at least 6 months
CRPC defined as tumor progression (PSA increase on at least 2 separate values separated by at least 1 week or progression on imaging) while on Androgen Deprivation Therapy (orchiectomy, LHRH agonist or -antagonist) with documented serum testosterone levels ≤ 1.7 nmol/L (≤ 0.50 ng/mL). Ongoing concurrent use of LHRH agonist or antagonist is required if the patient has not been surgically castrated
Presence (M1) or absence (M0) of metastases on imaging
Previous localised malignancy within 2 years with the exception of localized non-melanoma skin cancer and Ta or Tis bladder cancer (patients with asymptomatic Chronic Lymphocytic Leukemia can be included)
Previous metastatic malignancy within 5 years
Patient currently taking daily acetylsalicylic acid or a daily statin within the last 6 months
Patients with active liver disease (hepatitis B or C, cirrhosis) or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal or cholestasis
Gustave Roussy, Cancer Campus, Grand Paris
Lead sponsor
National Cancer Institute, France
Collaborator