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

Prior treatment

• 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
• Any concomitant drugs contraindicated for use with the trial drugs according to the product information (e.g. Fusidic acid, potent inhibitors of CYP3A4 or transport proteins: ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole and HIV protease inhibitors including ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir, telaprevir, saquinavir, darunavir, fosamprenavir, boceprevir, gemfibrozil, fenofibrate, etc)

Other illness

• Patients with excessive alcohol intake or history of a relevant liver disease
• Known hypersensitivity or intolerance to acetylsalicylic acid or atorvastatin or hypersensitivity to any of its components
• Contra-indication to acetylsalicylic acid or atorvastatin according to label, including known high-risk for haemorrhage,
• History of recent stroke or transient ischemic attack (TIA).
• Any serious underlying medical condition (by the investigator's judgement) which could impair the ability of the patient to participate in the trial
• Psychiatric disorder precluding understanding of information about trial related topics, providing informed consent, or interfering with compliance for oral drug intake

Lab values

• 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
• History of or active myopathy or significantly elevated (> 5 times ULN) CK levels
• Patients with hereditary galactose intolerance, Lapp-lactase deficiency or Glucose-Galactose-malabsorption

Other

• Compliance with trial medical follow-up impossible due to geographic, social or psychological reasons

• 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
• Performance status 0, 1 or 2
• No previous use of life- prolonging treatments for CRPC (including abiraterone, enzalutamide, radium-223, docetaxel, cabazitaxel, and sipuleucel-T). The use of these agents together with Androgen Deprivation Therapy (ADT) for castrate-sensitive disease is allowed.
• Adequate renal function within 30 days prior to registration: calculated creatinine clearance ≥ 50 mL/min, according to the formula of Cockcroft-Gault and adequate liver function with levels of AST and ALT ≤ 3xULN and no signs for cholestasis.
• Participation in other clinical trials is allowed except for trials with the same primary endpoint, i.e. OS
• Patient authorized to participate to a clinical trial by specific country regulation (eg patient affiliated to a social security system or beneficiary of the same)
• Information delivered to patient and informed consent form signed by the patient.